<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03266328</url>
  </required_header>
  <id_info>
    <org_study_id>17100289</org_study_id>
    <nct_id>NCT03266328</nct_id>
  </id_info>
  <brief_title>Procedure and In-hospital Outcome of Patients Under 40 Years Old Undergoing Primary Percutaneous Coronary Intervention for Acute ST Elevated Myocardial Infarction in Assiut University</brief_title>
  <official_title>Procedure and In-hospital Outcome of Patients Under 40 Years Old Undergoing Primary Percutaneous Coronary Intervention for Acute ST Elevated Myocardial Infarction in Assiut University</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sample size of 117 patients presented with ST elevated myocardial infarction for PPCI&#xD;
      starting from september 2017 will be divided to 2 groups, group 1 age up to 40 years old and&#xD;
      group 2 older than 40 years then previous history and clinical data and angiographic data at&#xD;
      PPCI and follow up in-hospital and after discharge for 3 months all these data will be&#xD;
      compared at both groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Myocardial infarction (MI) is a disease of middle and advanced age.&#xD;
&#xD;
      Most of the present knowledge of infarction is derived from studies in this older cohort of&#xD;
      patients.&#xD;
&#xD;
      In fact, some clinical studies of patients with chest pain have excluded individuals under 40&#xD;
      years of age&#xD;
&#xD;
      Although thrombolytic therapy has been shown to improve survival in elderly AMI patients when&#xD;
      compared with placebo, many studies have shown lower mortality rates when these patients are&#xD;
      treated with primary percutaneous coronary intervention(PPCI) for AMI&#xD;
&#xD;
      Young adults are a relatively small portion of those having acute myocardial infarction&#xD;
      (AMI). However they are an important group to examine with regard to risk factor modification&#xD;
      and secondary prevention.&#xD;
&#xD;
      Previous studies have estimated that young patients of less than 40 years old make up between&#xD;
      2% and 6% of all AMI&#xD;
&#xD;
      young patients has different characteristics from that in the older coronary arteriography&#xD;
      performed in young patients after myocardial infarction has identified a relatively high&#xD;
      prevalence of angiographically normal coronary arteries.&#xD;
&#xD;
      Risk factor analysis in young AMI patients has revealed a high prevalence of current smoking,&#xD;
      hyperlipidemia and positive family history&#xD;
&#xD;
      In addition, non-classical risk factors such as vasospastic tendencies, thrombophilic&#xD;
      conditions and a history of Kawasaki disease have also been proposed as the causes of AMI in&#xD;
      young patients.&#xD;
&#xD;
      PPCI is now widely accepted as a therapeutic strategy for older patients with AMI. Early,&#xD;
      complete revascularization can salvage myocardium at risk and improve survival rates.&#xD;
&#xD;
      However on the basis of the difference in etiology of AMI, there is a possibility that the&#xD;
      clinical effectiveness of PCI for young adults with AMI might be different from that old&#xD;
      patients&#xD;
&#xD;
      Nevertheless, coronary artery disease has been recognized in young age groups more frequently&#xD;
      in recent years.&#xD;
&#xD;
      It is a topic of increasing clinical interest due to the potential for premature death and&#xD;
      long-term disability.&#xD;
&#xD;
      Aim of the study :&#xD;
&#xD;
      The purpose of the present study is to examine the clinical background, angiographic&#xD;
      findings, acute results and in-hospital outcome of PPCI in young adults with AMI (less than&#xD;
      40 years) compared with those non young group (more than 40 years) .&#xD;
&#xD;
      Type of the study: case only , prospective study .Study Setting: cardiology department ,&#xD;
      assuit university hospital , assuit , Egypt&#xD;
&#xD;
      Study subjects:&#xD;
&#xD;
        1. Inclusion criteria:&#xD;
&#xD;
           All patients with acute myocardial infarction (STEMI) : chest pain &gt; 30 minutes and ST&#xD;
           segment elevation in more than one lead , treated with PPCI at assuit university&#xD;
           hospital starting from September 2017 .&#xD;
&#xD;
        2. Exclusion criteria:&#xD;
&#xD;
           Patients undergoing elective percutaneous intervention and thrombolytic therapy.&#xD;
&#xD;
        3. Sample Size Calculation: : Sample size was calculated using Epi-info version 3 , based&#xD;
           on previous studies , prevalence of MI in Egypt is 8.3 % , with confident level of 95 %&#xD;
           , the sample needed for the study was estimated to be about 117&#xD;
&#xD;
      Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …):&#xD;
&#xD;
      All patient will be subjected to :&#xD;
&#xD;
      1-history taking , clinical examination &amp; assessment of clinical risk factors of coronary&#xD;
      heart disease as ( age , sex , family history ,DM , HTN ,smoking , addiction and type of&#xD;
      addiction , previous ACS ,previous PCI , psychic trauma ,history of chest obstructive , renal&#xD;
      and vascular disease , weight ,length ,BMI ,BSA , obesity , KILLIP class , ischemic time ,&#xD;
      preinfarction angina ,mode of transport 2-12 lead ECG before and after PPCI. 3-Angiongraphic&#xD;
      findings, acute results of PPCI ( previous PCI , culprit artery , if MVD , which segment&#xD;
      affected ,presence or absence of visible thrombus ,type of penetrating wire ,direct stenting&#xD;
      or not ,type of the stent , name of the stent , number of stents , diameter and length of&#xD;
      each stent , usage of thrombus aspiration , balloon dilatation ,diameter and length of the&#xD;
      balloon ,and inflation pressure ,volume of contrast ,final TIMI flow ,presence of&#xD;
      collaterals.&#xD;
&#xD;
      4-evaluation of PCI success (in-hospital):&#xD;
&#xD;
      a-angiographic success :( residual stenosis ≤ 30% and TIMI flow grade 3) and side branch&#xD;
      angiographic success (residual stenosis ≤ 50% and TIMI flow grade 3)&#xD;
&#xD;
      a- procedural success : achievement of angiographic success without major clinical&#xD;
      complication as ( death ,MI ,emergency coronary artery bypass surgery ) during&#xD;
      hospitalization .&#xD;
&#xD;
      c- clinical success : in the short term , recovering of signs and symptoms of myocardial&#xD;
      ischemia .&#xD;
&#xD;
      5-Therapuetic data as ( aspirin loading dose , clopidogrel loading dose ,maintenance dose and&#xD;
      its duration , ticagrelor loading dose ,maintenance dose and its duration , usage of&#xD;
      tirofiban intracoronary or intravenous ) 6- echocardiographic finding during admission ( EF&#xD;
      by Simpson and M-mode , SWMA, mechanical complication ) 7-laboratory finding during admission&#xD;
      ( total cholesterol , LDL , HDL , TG , basal creatinine , creatinine at discharge ,basal CK&#xD;
      and CKMB , peak CK and CKMB , CK - CKMB - TNL at discharge , hemoglobin and platelet level )&#xD;
      8-follow up after 3 months for ( mortality , ACS, MI , target artery revascularization ,ISR&#xD;
      ,HF ,follow up echo EF by Simpson and M-mode , SWMA )&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2017</start_date>
  <completion_date type="Anticipated">August 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>clinical outcome</measure>
    <time_frame>48 hours</time_frame>
    <description>Evaluation of PCI success (in-hospital):&#xD;
angiographic success: (residual stenosis ≤ 30% and TIMI flow grade 3) and side branch angiographic success (residual stenosis ≤ 50% and TIMI flow grade 3) am&#xD;
procedural success: achievement of angiographic success without major clinical complication as (death, MI,emergency coronary artery bypass surgery) during hospitalization.&#xD;
clinical success: in the short term, recovering of signs and symptoms of myocardial ischemia.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">117</enrollment>
  <condition>ST Elevation Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>group 1</arm_group_label>
    <description>ST elevated myocardial infarction patient presented to assiut university hospital for Primary Percutaneous Coronary Intervention (PPCI) and their age is up to 40 years old</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group 2</arm_group_label>
    <description>ST elevated myocardial infarction patient presented to assiut university hospital for Primary Percutaneous Coronary Intervention (PPCI) and their age is more than 40 years old</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Primary Percutaneous Coronary Intervention (PPCI)</intervention_name>
    <description>Percutaneous Coronary Intervention in patients of acute myocardial infarction diagnosed using ECG findings</description>
    <arm_group_label>group 1</arm_group_label>
    <arm_group_label>group 2</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with acute myocardial infarction who receive treatment at Assiut University&#xD;
        Hospitals in the acute setting.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with acute myocardial infarction (STEMI): chest pain &gt; 30 minutes and ST&#xD;
             segment elevation in more than one lead, treated with PPCI at Assiut University&#xD;
             Hospitals starting from September 2017.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing elective percutaneous intervention and thrombolytic therapy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Assiut University Hospitals</name>
      <address>
        <city>Assiut</city>
        <zip>71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Mohamed T Galal, MBBCh</last_name>
      <email>mohamedtahagalal@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Salwa R Dimitry, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mohamed A Farghal, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mohamed A Abdelhafez, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Lee TH, Cook EF, Weisberg M, Sargent RK, Wilson C, Goldman L. Acute chest pain in the emergency room. Identification and examination of low-risk patients. Arch Intern Med. 1985 Jan;145(1):65-9.</citation>
    <PMID>3970650</PMID>
  </reference>
  <reference>
    <citation>Pozen MW, D'Agostino RB, Selker HP, Sytkowski PA, Hood WB Jr. A predictive instrument to improve coronary-care-unit admission practices in acute ischemic heart disease. A prospective multicenter clinical trial. N Engl J Med. 1984 May 17;310(20):1273-8. doi: 10.1056/NEJM198405173102001.</citation>
    <PMID>6371525</PMID>
  </reference>
  <reference>
    <citation>Towbin JA, Bricker JT, Garson A Jr. Electrocardiographic criteria for diagnosis of acute myocardial infarction in childhood. Am J Cardiol. 1992 Jun 15;69(19):1545-8. doi: 10.1016/0002-9149(92)90700-9.</citation>
    <PMID>1598867</PMID>
  </reference>
  <reference>
    <citation>Weinberger I, Rotenberg Z, Fuchs J, Sagy A, Friedmann J, Agmon J. Myocardial infarction in young adults under 30 years: risk factors and clinical course. Clin Cardiol. 1987 Jan;10(1):9-15. doi: 10.1002/clc.4960100104.</citation>
    <PMID>3815921</PMID>
  </reference>
  <reference>
    <citation>Chouhan L, Hajar HA, Pomposiello JC. Comparison of thrombolytic therapy for acute myocardial infarction in patients aged &lt; 35 and &gt; 55 years. Am J Cardiol. 1993 Jan 15;71(2):157-9. doi: 10.1016/0002-9149(93)90731-q.</citation>
    <PMID>8421976</PMID>
  </reference>
  <reference>
    <citation>Perski A, Olsson G, Landou C, de Faire U, Theorell T, Hamsten A. Minimum heart rate and coronary atherosclerosis: independent relations to global severity and rate of progression of angiographic lesions in men with myocardial infarction at a young age. Am Heart J. 1992 Mar;123(3):609-16. doi: 10.1016/0002-8703(92)90497-j.</citation>
    <PMID>1539512</PMID>
  </reference>
  <reference>
    <citation>Weaver WD, Litwin PE, Martin JS, Kudenchuk PJ, Maynard C, Eisenberg MS, Ho MT, Cobb LA, Kennedy JW, Wirkus MS. Effect of age on use of thrombolytic therapy and mortality in acute myocardial infarction. The MITI Project Group. J Am Coll Cardiol. 1991 Sep;18(3):657-62. doi: 10.1016/0735-1097(91)90784-7.</citation>
    <PMID>1869726</PMID>
  </reference>
  <reference>
    <citation>Global Use of Strategies to Open Occluded Coronary Arteries in Acute Coronary Syndromes (GUSTO IIb) Angioplasty Substudy Investigators. A clinical trial comparing primary coronary angioplasty with tissue plasminogen activator for acute myocardial infarction. N Engl J Med. 1997 Jun 5;336(23):1621-8. doi: 10.1056/NEJM199706053362301. Erratum In: N Engl J Med 1997 Jul 24;337(4):287.</citation>
    <PMID>9173270</PMID>
  </reference>
  <reference>
    <citation>Zimmerman FH, Cameron A, Fisher LD, Ng G. Myocardial infarction in young adults: angiographic characterization, risk factors and prognosis (Coronary Artery Surgery Study Registry). J Am Coll Cardiol. 1995 Sep;26(3):654-61. doi: 10.1016/0735-1097(95)00254-2.</citation>
    <PMID>7642855</PMID>
  </reference>
  <reference>
    <citation>Fournier JA, Sanchez A, Quero J, Fernandez-Cortacero JA, Gonzalez-Barrero A. Myocardial infarction in men aged 40 years or less: a prospective clinical-angiographic study. Clin Cardiol. 1996 Aug;19(8):631-6. doi: 10.1002/clc.4960190809.</citation>
    <PMID>8864336</PMID>
  </reference>
  <reference>
    <citation>Imazio M, Bobbio M, Bergerone S, Barlera S, Maggioni AP. Clinical and epidemiological characteristics of juvenile myocardial infarction in Italy: the GISSI experience. G Ital Cardiol. 1998 May;28(5):505-12.</citation>
    <PMID>9646064</PMID>
  </reference>
  <reference>
    <citation>Kannel WB, Abbott RD. Incidence and prognosis of unrecognized myocardial infarction. An update on the Framingham study. N Engl J Med. 1984 Nov 1;311(18):1144-7. doi: 10.1056/NEJM198411013111802.</citation>
    <PMID>6482932</PMID>
  </reference>
  <reference>
    <citation>Warren SE, Thompson SI, Vieweg WV. Historic and angiographic features of young adults surviving myocardial infarction. Chest. 1979 Jun;75(6):667-70. doi: 10.1378/chest.75.6.667.</citation>
    <PMID>436516</PMID>
  </reference>
  <reference>
    <citation>Wolfe MW, Vacek JL. Myocardial infarction in the young. Angiographic features and risk factor analysis of patients with myocardial infarction at or before the age of 35 years. Chest. 1988 Nov;94(5):926-30. doi: 10.1378/chest.94.5.926.</citation>
    <PMID>3180896</PMID>
  </reference>
  <reference>
    <citation>Davia JE, Hallal FJ, Cheitlin MD, Gregoratos G, McCarty R, Foote W. Coronary artery disease in young patients: arteriographic and clinical review of 40 cases aged 35 and under. Am Heart J. 1974 Jun;87(6):689-96. doi: 10.1016/0002-8703(74)90412-8. No abstract available.</citation>
    <PMID>4828802</PMID>
  </reference>
  <reference>
    <citation>Thompson SI, Vieweg WV, Alpert JS, Hagan AD. Incidence and age distribution of patients with myocardial infarction and normal coronary arteriograms. Cathet Cardiovasc Diagn. 1977;3(1):1-9. doi: 10.1002/ccd.1810030102.</citation>
    <PMID>837428</PMID>
  </reference>
  <reference>
    <citation>Glover MU, Kuber MT, Warren SE, Vieweg WV. Myocardial infarction before age 36: risk factor and arteriographic analysis. Am J Cardiol. 1982 May;49(7):1600-3. doi: 10.1016/0002-9149(82)90234-x.</citation>
    <PMID>6123253</PMID>
  </reference>
  <reference>
    <citation>Waters DD, Halphen C, Theroux P, David PR, Mizgala HF. Coronary artery disease in young women: clinical and angiographic features and correlation with risk factors. Am J Cardiol. 1978 Jul;42(1):41-7. doi: 10.1016/0002-9149(78)90982-7.</citation>
    <PMID>677035</PMID>
  </reference>
  <reference>
    <citation>Salem BI, Haikal M, Zambrano A, Bollis A, Gowda S. Acute myocardial infarction with &quot;normal&quot; coronary arteries: clinical and angiographic profiles, with ergonovine testing. Tex Heart Inst J. 1985 Mar;12(1):1-7.</citation>
    <PMID>15227036</PMID>
  </reference>
  <reference>
    <citation>Wei JY, Bulkley BH. Myocardial infarction before age 36 years in women: predominance of apparent nonatherosclerotic events. Am Heart J. 1982 Sep;104(3):561-6. doi: 10.1016/0002-8703(82)90227-7.</citation>
    <PMID>7113896</PMID>
  </reference>
  <reference>
    <citation>Welch CC, Proudfit WL, Sheldon WC. Coronary arteriographic findings in 1,000 women under age 50. Am J Cardiol. 1975 Feb;35(2):211-5. doi: 10.1016/0002-9149(75)90003-x.</citation>
    <PMID>1168016</PMID>
  </reference>
  <reference>
    <citation>Engel HJ, Engel E, Lichtlen PR. Coronary atherosclerosis and myocardial infarction in young women--role of oral contraceptives. Eur Heart J. 1983 Jan;4(1):1-6. doi: 10.1093/oxfordjournals.eurheartj.a061365. No abstract available.</citation>
    <PMID>6832174</PMID>
  </reference>
  <reference>
    <citation>Garoufalis S, Kouvaras G, Vitsias G, Perdikouris K, Markatou P, Hatzisavas J, Kassinos N, Karidis K, Foussas S. Comparison of angiographic findings, risk factors, and long term follow-up between young and old patients with a history of myocardial infarction. Int J Cardiol. 1998 Nov 30;67(1):75-80. doi: 10.1016/s0167-5273(98)00194-6.</citation>
    <PMID>9880203</PMID>
  </reference>
  <reference>
    <citation>Williams MJ, Restieaux NJ, Low CJ. Myocardial infarction in young people with normal coronary arteries. Heart. 1998 Feb;79(2):191-4. doi: 10.1136/hrt.79.2.191.</citation>
    <PMID>9538315</PMID>
  </reference>
  <reference>
    <citation>Choudhury L, Marsh JD. Myocardial infarction in young patients. Am J Med. 1999 Sep;107(3):254-61. doi: 10.1016/s0002-9343(99)00218-1.</citation>
    <PMID>10492319</PMID>
  </reference>
  <reference>
    <citation>Doughty M, Mehta R, Bruckman D, Das S, Karavite D, Tsai T, Eagle K. Acute myocardial infarction in the young--The University of Michigan experience. Am Heart J. 2002 Jan;143(1):56-62. doi: 10.1067/mhj.2002.120300.</citation>
    <PMID>11773912</PMID>
  </reference>
  <reference>
    <citation>Suzuki A, Yamagishi M, Kimura K, Sugiyama H, Arakaki Y, Kamiya T, Miyatake K. Functional behavior and morphology of the coronary artery wall in patients with Kawasaki disease assessed by intravascular ultrasound. J Am Coll Cardiol. 1996 Feb;27(2):291-6. doi: 10.1016/0735-1097(95)00447-5.</citation>
    <PMID>8557896</PMID>
  </reference>
  <reference>
    <citation>Saigo M, Waters DD, Abe S, Biro S, Minagoe S, Maruyama I, Tei C. Soluble fibrin, C-reactive protein, fibrinogen, factor VII, antithrombin, proteins C and S, tissue factor, D-dimer, and prothrombin fragment 1 + 2 in men with acute myocardial infarction &lt;/=45 years of age. Am J Cardiol. 2004 Dec 1;94(11):1410-3. doi: 10.1016/j.amjcard.2004.07.144.</citation>
    <PMID>15566913</PMID>
  </reference>
  <reference>
    <citation>. The AMI-Kyoto Multi-Center Risk Study, a large multicenter observational study in which 15 collaborating hospitals in Kyoto Prefecture have collected demographic, procedural and outcome data on AMI patients, was established in 2000 in order to analyze this data and establish an emergency-hospital network for heart diseases in Kyoto</citation>
  </reference>
  <reference>
    <citation>Lamm G. The epidcmiology of acutc myocardial infarction in young age groups. In: Roskamm H, editor. Mw&gt;cardial infarction at young age. Berlin:Springer-Verlag, 1981:5-12</citation>
  </reference>
  <reference>
    <citation>Burkart F, Salzmann C Angiographic findings in postinfarction patientsunder the age of 35. In ref. 2:56 60</citation>
  </reference>
  <reference>
    <citation>Motet P, Gutzwiller F, Junod B. Coronary artery disease in young adults under 35 years old: risk factors. In ref. 2:17-</citation>
  </reference>
  <reference>
    <citation>Gohlke H, Sturzenhofecker P, Thilo A, Droste C, Gornandt L, Roskamm Coronary angiographic findings and risk factors in postinfarction patients In ref. 2:61-77</citation>
  </reference>
  <reference>
    <citation>Hoit BD, Gilpin EA, Henning H, Maisel AA, Dittrich H, Carlisle J, Ross J Jr. Myocardial infarction in young patients: an analysis by age subsets. Circulation. 1986 Oct;74(4):712-21. doi: 10.1161/01.cir.74.4.712.</citation>
    <PMID>3757185</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>August 28, 2017</last_update_submitted>
  <last_update_submitted_qc>August 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>mohamed taha galal</investigator_full_name>
    <investigator_title>resident at cardiology department at assiut university hospital</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>ST Elevation Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03266328
org study id: 17100289
nct id: NCT03266328
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Sample size of 117 patients presented with ST elevated myocardial infarction for PPCI
      starting from september 2017 will be divided to 2 groups, group 1 age up to 40 years old and
      group 2 older than 40 years then previous history and clinical data and angiographic data at
      PPCI and follow up in-hospital and after discharge for 3 months all these data will be
      compared at both groups.
Myocardial infarction (MI) is a disease of middle and advanced age.

      Most of the present knowledge of infarction is derived from studies in this older cohort of
      patients.

      In fact, some clinical studies of patients with chest pain have excluded individuals under 40
      years of age

      Although thrombolytic therapy has been shown to improve survival in elderly AMI patients when
      compared with placebo, many studies have shown lower mortality rates when these patients are
      treated with primary percutaneous coronary intervention(PPCI) for AMI

      Young adults are a relatively small portion of those having acute myocardial infarction
      (AMI). However they are an important group to examine with regard to risk factor modification
      and secondary prevention.

      Previous studies have estimated that young patients of less than 40 years old make up between
      2% and 6% of all AMI

      young patients has different characteristics from that in the older coronary arteriography
      performed in young patients after myocardial infarction has identified a relatively high
      prevalence of angiographically normal coronary arteries.

      Risk factor analysis in young AMI patients has revealed a high prevalence of current smoking,
      hyperlipidemia and positive family history

      In addition, non-classical risk factors such as vasospastic tendencies, thrombophilic
      conditions and a history of Kawasaki disease have also been proposed as the causes of AMI in
      young patients.

      PPCI is now widely accepted as a therapeutic strategy for older patients with AMI. Early,
      complete revascularization can salvage myocardium at risk and improve survival rates.

      However on the basis of the difference in etiology of AMI, there is a possibility that the
      clinical effectiveness of PCI for young adults with AMI might be different from that old
      patients

      Nevertheless, coronary artery disease has been recognized in young age groups more frequently
      in recent years.

      It is a topic of increasing clinical interest due to the potential for premature death and
      long-term disability.

      Aim of the study :

      The purpose of the present study is to examine the clinical background, angiographic
      findings, acute results and in-hospital outcome of PPCI in young adults with AMI (less than
      40 years) compared with those non young group (more than 40 years) .

      Type of the study: case only , prospective study .Study Setting: cardiology department ,
      assuit university hospital , assuit , Egypt

      Study subjects:

        1. Inclusion criteria:

           All patients with acute myocardial infarction (STEMI) : chest pain > 30 minutes and ST
           segment elevation in more than one lead , treated with PPCI at assuit university
           hospital starting from September 2017 .

        2. Exclusion criteria:

           Patients undergoing elective percutaneous intervention and thrombolytic therapy.

        3. Sample Size Calculation: : Sample size was calculated using Epi-info version 3 , based
           on previous studies , prevalence of MI in Egypt is 8.3 % , with confident level of 95 %
           , the sample needed for the study was estimated to be about 117

      Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …):

      All patient will be subjected to :

      1-history taking , clinical examination & assessment of clinical risk factors of coronary
      heart disease as ( age , sex , family history ,DM , HTN ,smoking , addiction and type of
      addiction , previous ACS ,previous PCI , psychic trauma ,history of chest obstructive , renal
      and vascular disease , weight ,length ,BMI ,BSA , obesity , KILLIP class , ischemic time ,
      preinfarction angina ,mode of transport 2-12 lead ECG before and after PPCI. 3-Angiongraphic
      findings, acute results of PPCI ( previous PCI , culprit artery , if MVD , which segment
      affected ,presence or absence of visible thrombus ,type of penetrating wire ,direct stenting
      or not ,type of the stent , name of the stent , number of stents , diameter and length of
      each stent , usage of thrombus aspiration , balloon dilatation ,diameter and length of the
      balloon ,and inflation pressure ,volume of contrast ,final TIMI flow ,presence of
      collaterals.

      4-evaluation of PCI success (in-hospital):

      a-angiographic success :( residual stenosis ≤ 30% and TIMI flow grade 3) and side branch
      angiographic success (residual stenosis ≤ 50% and TIMI flow grade 3)

      a- procedural success : achievement of angiographic success without major clinical
      complication as ( death ,MI ,emergency coronary artery bypass surgery ) during
      hospitalization .

      c- clinical success : in the short term , recovering of signs and symptoms of myocardial
      ischemia .

      5-Therapuetic data as ( aspirin loading dose , clopidogrel loading dose ,maintenance dose and
      its duration , ticagrelor loading dose ,maintenance dose and its duration , usage of
      tirofiban intracoronary or intravenous ) 6- echocardiographic finding during admission ( EF
      by Simpson and M-mode , SWMA, mechanical complication ) 7-laboratory finding during admission
      ( total cholesterol , LDL , HDL , TG , basal creatinine , creatinine at discharge ,basal CK
      and CKMB , peak CK and CKMB , CK - CKMB - TNL at discharge , hemoglobin and platelet level )
      8-follow up after 3 months for ( mortality , ACS, MI , target artery revascularization ,ISR
      ,HF ,follow up echo EF by Simpson and M-mode , SWMA )
observational model: Case-Only
time perspective: Prospective
measure: clinical outcome
time frame: 48 hours
description: Evaluation of PCI success (in-hospital):
angiographic success: (residual stenosis ≤ 30% and TIMI flow grade 3) and side branch angiographic success (residual stenosis ≤ 50% and TIMI flow grade 3) am
procedural success: achievement of angiographic success without major clinical complication as (death, MI,emergency coronary artery bypass surgery) during hospitalization.
clinical success: in the short term, recovering of signs and symptoms of myocardial ischemia.
arm group label: group 1
description: ST elevated myocardial infarction patient presented to assiut university hospital for Primary Percutaneous Coronary Intervention (PPCI) and their age is up to 40 years old
arm group label: group 2
description: ST elevated myocardial infarction patient presented to assiut university hospital for Primary Percutaneous Coronary Intervention (PPCI) and their age is more than 40 years old
intervention type: Procedure
intervention name: Primary Percutaneous Coronary Intervention (PPCI)
description: Percutaneous Coronary Intervention in patients of acute myocardial infarction diagnosed using ECG findings
arm group label: group 1
arm group label: group 2
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
contact: 
investigator: 
investigator: 
investigator: 
country: Egypt
citation: Lee TH, Cook EF, Weisberg M, Sargent RK, Wilson C, Goldman L. Acute chest pain in the emergency room. Identification and examination of low-risk patients. Arch Intern Med. 1985 Jan;145(1):65-9.
PMID: 3970650
citation: Pozen MW, D'Agostino RB, Selker HP, Sytkowski PA, Hood WB Jr. A predictive instrument to improve coronary-care-unit admission practices in acute ischemic heart disease. A prospective multicenter clinical trial. N Engl J Med. 1984 May 17;310(20):1273-8. doi: 10.1056/NEJM198405173102001.
PMID: 6371525
citation: Towbin JA, Bricker JT, Garson A Jr. Electrocardiographic criteria for diagnosis of acute myocardial infarction in childhood. Am J Cardiol. 1992 Jun 15;69(19):1545-8. doi: 10.1016/0002-9149(92)90700-9.
PMID: 1598867
citation: Weinberger I, Rotenberg Z, Fuchs J, Sagy A, Friedmann J, Agmon J. Myocardial infarction in young adults under 30 years: risk factors and clinical course. Clin Cardiol. 1987 Jan;10(1):9-15. doi: 10.1002/clc.4960100104.
PMID: 3815921
citation: Chouhan L, Hajar HA, Pomposiello JC. Comparison of thrombolytic therapy for acute myocardial infarction in patients aged < 35 and > 55 years. Am J Cardiol. 1993 Jan 15;71(2):157-9. doi: 10.1016/0002-9149(93)90731-q.
PMID: 8421976
citation: Perski A, Olsson G, Landou C, de Faire U, Theorell T, Hamsten A. Minimum heart rate and coronary atherosclerosis: independent relations to global severity and rate of progression of angiographic lesions in men with myocardial infarction at a young age. Am Heart J. 1992 Mar;123(3):609-16. doi: 10.1016/0002-8703(92)90497-j.
PMID: 1539512
citation: Weaver WD, Litwin PE, Martin JS, Kudenchuk PJ, Maynard C, Eisenberg MS, Ho MT, Cobb LA, Kennedy JW, Wirkus MS. Effect of age on use of thrombolytic therapy and mortality in acute myocardial infarction. The MITI Project Group. J Am Coll Cardiol. 1991 Sep;18(3):657-62. doi: 10.1016/0735-1097(91)90784-7.
PMID: 1869726
citation: Global Use of Strategies to Open Occluded Coronary Arteries in Acute Coronary Syndromes (GUSTO IIb) Angioplasty Substudy Investigators. A clinical trial comparing primary coronary angioplasty with tissue plasminogen activator for acute myocardial infarction. N Engl J Med. 1997 Jun 5;336(23):1621-8. doi: 10.1056/NEJM199706053362301. Erratum In: N Engl J Med 1997 Jul 24;337(4):287.
PMID: 9173270
citation: Zimmerman FH, Cameron A, Fisher LD, Ng G. Myocardial infarction in young adults: angiographic characterization, risk factors and prognosis (Coronary Artery Surgery Study Registry). J Am Coll Cardiol. 1995 Sep;26(3):654-61. doi: 10.1016/0735-1097(95)00254-2.
PMID: 7642855
citation: Fournier JA, Sanchez A, Quero J, Fernandez-Cortacero JA, Gonzalez-Barrero A. Myocardial infarction in men aged 40 years or less: a prospective clinical-angiographic study. Clin Cardiol. 1996 Aug;19(8):631-6. doi: 10.1002/clc.4960190809.
PMID: 8864336
citation: Imazio M, Bobbio M, Bergerone S, Barlera S, Maggioni AP. Clinical and epidemiological characteristics of juvenile myocardial infarction in Italy: the GISSI experience. G Ital Cardiol. 1998 May;28(5):505-12.
PMID: 9646064
citation: Kannel WB, Abbott RD. Incidence and prognosis of unrecognized myocardial infarction. An update on the Framingham study. N Engl J Med. 1984 Nov 1;311(18):1144-7. doi: 10.1056/NEJM198411013111802.
PMID: 6482932
citation: Warren SE, Thompson SI, Vieweg WV. Historic and angiographic features of young adults surviving myocardial infarction. Chest. 1979 Jun;75(6):667-70. doi: 10.1378/chest.75.6.667.
PMID: 436516
citation: Wolfe MW, Vacek JL. Myocardial infarction in the young. Angiographic features and risk factor analysis of patients with myocardial infarction at or before the age of 35 years. Chest. 1988 Nov;94(5):926-30. doi: 10.1378/chest.94.5.926.
PMID: 3180896
citation: Davia JE, Hallal FJ, Cheitlin MD, Gregoratos G, McCarty R, Foote W. Coronary artery disease in young patients: arteriographic and clinical review of 40 cases aged 35 and under. Am Heart J. 1974 Jun;87(6):689-96. doi: 10.1016/0002-8703(74)90412-8. No abstract available.
PMID: 4828802
citation: Thompson SI, Vieweg WV, Alpert JS, Hagan AD. Incidence and age distribution of patients with myocardial infarction and normal coronary arteriograms. Cathet Cardiovasc Diagn. 1977;3(1):1-9. doi: 10.1002/ccd.1810030102.
PMID: 837428
citation: Glover MU, Kuber MT, Warren SE, Vieweg WV. Myocardial infarction before age 36: risk factor and arteriographic analysis. Am J Cardiol. 1982 May;49(7):1600-3. doi: 10.1016/0002-9149(82)90234-x.
PMID: 6123253
citation: Waters DD, Halphen C, Theroux P, David PR, Mizgala HF. Coronary artery disease in young women: clinical and angiographic features and correlation with risk factors. Am J Cardiol. 1978 Jul;42(1):41-7. doi: 10.1016/0002-9149(78)90982-7.
PMID: 677035
citation: Salem BI, Haikal M, Zambrano A, Bollis A, Gowda S. Acute myocardial infarction with "normal" coronary arteries: clinical and angiographic profiles, with ergonovine testing. Tex Heart Inst J. 1985 Mar;12(1):1-7.
PMID: 15227036
citation: Wei JY, Bulkley BH. Myocardial infarction before age 36 years in women: predominance of apparent nonatherosclerotic events. Am Heart J. 1982 Sep;104(3):561-6. doi: 10.1016/0002-8703(82)90227-7.
PMID: 7113896
citation: Welch CC, Proudfit WL, Sheldon WC. Coronary arteriographic findings in 1,000 women under age 50. Am J Cardiol. 1975 Feb;35(2):211-5. doi: 10.1016/0002-9149(75)90003-x.
PMID: 1168016
citation: Engel HJ, Engel E, Lichtlen PR. Coronary atherosclerosis and myocardial infarction in young women--role of oral contraceptives. Eur Heart J. 1983 Jan;4(1):1-6. doi: 10.1093/oxfordjournals.eurheartj.a061365. No abstract available.
PMID: 6832174
citation: Garoufalis S, Kouvaras G, Vitsias G, Perdikouris K, Markatou P, Hatzisavas J, Kassinos N, Karidis K, Foussas S. Comparison of angiographic findings, risk factors, and long term follow-up between young and old patients with a history of myocardial infarction. Int J Cardiol. 1998 Nov 30;67(1):75-80. doi: 10.1016/s0167-5273(98)00194-6.
PMID: 9880203
citation: Williams MJ, Restieaux NJ, Low CJ. Myocardial infarction in young people with normal coronary arteries. Heart. 1998 Feb;79(2):191-4. doi: 10.1136/hrt.79.2.191.
PMID: 9538315
citation: Choudhury L, Marsh JD. Myocardial infarction in young patients. Am J Med. 1999 Sep;107(3):254-61. doi: 10.1016/s0002-9343(99)00218-1.
PMID: 10492319
citation: Doughty M, Mehta R, Bruckman D, Das S, Karavite D, Tsai T, Eagle K. Acute myocardial infarction in the young--The University of Michigan experience. Am Heart J. 2002 Jan;143(1):56-62. doi: 10.1067/mhj.2002.120300.
PMID: 11773912
citation: Suzuki A, Yamagishi M, Kimura K, Sugiyama H, Arakaki Y, Kamiya T, Miyatake K. Functional behavior and morphology of the coronary artery wall in patients with Kawasaki disease assessed by intravascular ultrasound. J Am Coll Cardiol. 1996 Feb;27(2):291-6. doi: 10.1016/0735-1097(95)00447-5.
PMID: 8557896
citation: Saigo M, Waters DD, Abe S, Biro S, Minagoe S, Maruyama I, Tei C. Soluble fibrin, C-reactive protein, fibrinogen, factor VII, antithrombin, proteins C and S, tissue factor, D-dimer, and prothrombin fragment 1 + 2 in men with acute myocardial infarction </=45 years of age. Am J Cardiol. 2004 Dec 1;94(11):1410-3. doi: 10.1016/j.amjcard.2004.07.144.
PMID: 15566913
citation: . The AMI-Kyoto Multi-Center Risk Study, a large multicenter observational study in which 15 collaborating hospitals in Kyoto Prefecture have collected demographic, procedural and outcome data on AMI patients, was established in 2000 in order to analyze this data and establish an emergency-hospital network for heart diseases in Kyoto
citation: Lamm G. The epidcmiology of acutc myocardial infarction in young age groups. In: Roskamm H, editor. Mw>cardial infarction at young age. Berlin:Springer-Verlag, 1981:5-12
citation: Burkart F, Salzmann C Angiographic findings in postinfarction patientsunder the age of 35. In ref. 2:56 60
citation: Motet P, Gutzwiller F, Junod B. Coronary artery disease in young adults under 35 years old: risk factors. In ref. 2:17-
citation: Gohlke H, Sturzenhofecker P, Thilo A, Droste C, Gornandt L, Roskamm Coronary angiographic findings and risk factors in postinfarction patients In ref. 2:61-77
citation: Hoit BD, Gilpin EA, Henning H, Maisel AA, Dittrich H, Carlisle J, Ross J Jr. Myocardial infarction in young patients: an analysis by age subsets. Circulation. 1986 Oct;74(4):712-21. doi: 10.1161/01.cir.74.4.712.
PMID: 3757185
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: mohamed taha galal
investigator title: resident at cardiology department at assiut university hospital
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Infarction
sharing ipd: No