<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/NCT02989077</url>
  </required_header>
  <id_info>
    <org_study_id>ECCVA</org_study_id>
    <nct_id>NCT02989077</nct_id>
  </id_info>
  <brief_title>Risk Profiling for Patients With Isolated or Combined Coronary and Cerebral Ischemia, and Current Management Status</brief_title>
  <official_title>Risk Profiling for Patients With Isolated or Combined Coronary and Cerebral Ischemia, and Their Current Status of Risk Factors Control</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Egyptian Cerebro-Cardio-Vascular Association</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Egyptian Cerebro-Cardio-Vascular Association</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will delineate the risk profile of patients with isolated cerebral or coronary&#xD;
      ischemia and those with combined disease. The study will also evaluate current management&#xD;
      status of those patients and any unmet needs.This aim is proposed to be achieved by studying&#xD;
      3 groups of patients with coronary, cerebral or combined ischemia. Anticipated each group to&#xD;
      be 1000 patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: most of available data are designed to show risk profile of either coronary or&#xD;
      cerebral ischemia, few data compared both risk profiles or tried to outline risk factors for&#xD;
      combined ischemia.&#xD;
&#xD;
      The aim is to compare risk profile of isolated coronary, cerebral ischemia or combined&#xD;
      disease to find out specific profile for each territory affection. Current management of risk&#xD;
      factors will be documented to find out any unmet needs specially for sicker patients with&#xD;
      combined ischemia.&#xD;
&#xD;
      Material and methods: 3 groups of patients representing coronary, cerebral and combined&#xD;
      ischemia.will be studied.&#xD;
&#xD;
      Documentation of coronary ischemia will be either by history of coronary care unit admission,&#xD;
      ECG documenting an infarction or ischemia, other noninvasive testing, previous coronary&#xD;
      intervention or coronary artery bypass grafting. Documentation of cerebral ischemia will be&#xD;
      by history, examination for a neurological deficit or any imaging modality documenting&#xD;
      cerebral ischemia (brain CT, MRI or duplex whether for extra or intracranial vessels).&#xD;
&#xD;
      Risk factor analysis will be for the known risk factors like, age, sex, family history,&#xD;
      smoking, recurrent events (like more than one coronary event), sedentary life, waist/hip&#xD;
      ratio, BMI, diabetes(history, duration, current medication and current control status,&#xD;
      HbA1c), hypertension (history, duration, current drug treatment and current control status).&#xD;
      hypercholesterolemia (history, duration, drug treatment and control with current evaluation&#xD;
      of LDL, HDL, TG, ApoB/ApoA), hs-CRP, presence of AF( drug treatment).&#xD;
&#xD;
      Full patient data will be obtained in a Case Report Form (CRF) based format. CRF format will&#xD;
      be designed by the steering committee. Investigators at clinics or centers who agree to&#xD;
      share, will be committed to fulfill this CRF and send electronic form to central workstation&#xD;
      for database saving.&#xD;
&#xD;
      Filling the CRF will be based on a single interview between the investigator and the patient,&#xD;
      and any missing data or investigation that mandates another interview will be allowed to&#xD;
      complete the CRF within a period of 30 days.&#xD;
&#xD;
      Center or investigator agreement will be signed first to be involved in the study and to&#xD;
      receive the CRF.&#xD;
&#xD;
      All patients will sign a written consent to share in the study.&#xD;
&#xD;
      Data analysis will be presented as mean or numbers (%). The significance of relation between&#xD;
      qualitative variables will be analysed by chi-square test or Fisher's exact test as&#xD;
      indicated. The distribution of means among groups will be analysed by student t testor ANOVA&#xD;
      as appropriate.&#xD;
&#xD;
      Correlation between quantitative variables will be studied by correlation coefficient.&#xD;
&#xD;
      Independent predictors of primary outcomes will be analysed by logistic regression analysis&#xD;
      and cox regression analysis as indicated.&#xD;
&#xD;
      .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">March 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>30 Days</target_duration>
  <primary_outcome>
    <measure>Incidence of presence and control status for known risk factors (defined by questionnaire from history, clinical examination, laboratory testing) in each group of patients.</measure>
    <time_frame>12 months (after finishing of patients recruitment).</time_frame>
    <description>Number of patients in each group of having the risk factors and whether each risk factor is controlled or not?</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparing data of the incidence between groups (statistically) may result in a specific risk profile for combined coronary and cerebral ischemia.</measure>
    <time_frame>12 months, after calculating the incidence of risk factors in each group.</time_frame>
    <description>Data of the incidence of risk factors will be compared between different group.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Discovering unmet needs in controlling risk factors in our patients</measure>
    <time_frame>24 months, after revising and releasing incidence data, risk factors control will be subjected to analysis and comparison to the standard care.</time_frame>
    <description>Any management gap for risk factors (defined as under diagnosis, under treatment, or uncontrolled patients) will be recorded .To arise awareness of the health care system (including decision makers and public community) regarding any management gap.</description>
  </other_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Ischemia, Myocardial</condition>
  <condition>Risk Factor, Cardiovascular</condition>
  <condition>Ischemia, Cerebral</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <description>Having combined coronary and cerebral ischemia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <description>Having only coronary ischemia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group C</arm_group_label>
    <description>Having only cerebral ischemia</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Any coronary or cerebral ischemic patients diagnosed in the ICU or at follow up in the&#xD;
        outpatient clinics will be enrolled in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Coronary ischemic patients diagnosed by history, non invasive testing, previous&#xD;
             intervention or previous CABG.&#xD;
&#xD;
          -  Cerebral ischemic patients diagnosed by history, neurological deficit or imaging&#xD;
             suggestive of brain ischemia or extra-cranial, intracranial arterial atherosclerotic&#xD;
             disease.&#xD;
&#xD;
          -  Combined cerebral and coronary ischemia diagnosed by the mentioned criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe heart failure.&#xD;
&#xD;
          -  Severe neurological deficit .&#xD;
&#xD;
          -  Significant severe co-morbidities with multiple medications.&#xD;
&#xD;
          -  Any missing clinical, drug or laboratory data from the data needed for Case Report&#xD;
             Form completion.&#xD;
&#xD;
          -  Any patient refused to sign to the written consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Bassem E Badr, Doctorate</last_name>
    <phone>+201223950548</phone>
    <email>bassemzarif@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marwa M Zaki, BPharm</last_name>
    <phone>+20226246160</phone>
    <email>dr.marwamamdouh@ymail.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Emerging Risk Factors Collaboration; Di Angelantonio E, Kaptoge S, Wormser D, Willeit P, Butterworth AS, Bansal N, O'Keeffe LM, Gao P, Wood AM, Burgess S, Freitag DF, Pennells L, Peters SA, Hart CL, Haheim LL, Gillum RF, Nordestgaard BG, Psaty BM, Yeap BB, Knuiman MW, Nietert PJ, Kauhanen J, Salonen JT, Kuller LH, Simons LA, van der Schouw YT, Barrett-Connor E, Selmer R, Crespo CJ, Rodriguez B, Verschuren WM, Salomaa V, Svardsudd K, van der Harst P, Bjorkelund C, Wilhelmsen L, Wallace RB, Brenner H, Amouyel P, Barr EL, Iso H, Onat A, Trevisan M, D'Agostino RB Sr, Cooper C, Kavousi M, Welin L, Roussel R, Hu FB, Sato S, Davidson KW, Howard BV, Leening MJ, Leening M, Rosengren A, Dorr M, Deeg DJ, Kiechl S, Stehouwer CD, Nissinen A, Giampaoli S, Donfrancesco C, Kromhout D, Price JF, Peters A, Meade TW, Casiglia E, Lawlor DA, Gallacher J, Nagel D, Franco OH, Assmann G, Dagenais GR, Jukema JW, Sundstrom J, Woodward M, Brunner EJ, Khaw KT, Wareham NJ, Whitsel EA, Njolstad I, Hedblad B, Wassertheil-Smoller S, Engstrom G, Rosamond WD, Selvin E, Sattar N, Thompson SG, Danesh J. Association of Cardiometabolic Multimorbidity With Mortality. JAMA. 2015 Jul 7;314(1):52-60. doi: 10.1001/jama.2015.7008. Erratum In: JAMA. 2015 Sep 15;314(11):1179. Leening, Maarten [corrected to Leening, Maarten J G].</citation>
    <PMID>26151266</PMID>
  </reference>
  <reference>
    <citation>Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L; INTERHEART Study Investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):937-52. doi: 10.1016/S0140-6736(04)17018-9.</citation>
    <PMID>15364185</PMID>
  </reference>
  <reference>
    <citation>Soler EP, Ruiz VC. Epidemiology and risk factors of cerebral ischemia and ischemic heart diseases: similarities and differences. Curr Cardiol Rev. 2010 Aug;6(3):138-49. doi: 10.2174/157340310791658785.</citation>
    <PMID>21804773</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>December 7, 2016</last_update_submitted>
  <last_update_submitted_qc>December 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Egyptian Cerebro-Cardio-Vascular Association</investigator_affiliation>
    <investigator_full_name>Bassem zarif</investigator_full_name>
    <investigator_title>Consultant cardiologist, Vise president of Egyptian cerebro-cardio-vascular Association</investigator_title>
  </responsible_party>
  <keyword>combined coronary and cerebral ischemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Ischemia</mesh_term>
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>after recruiting sites and investigators.</ipd_description>
  </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/NCT02989077
org study id: ECCVA
nct id: NCT02989077
lead sponsor: 
has dmc: Yes
This study will delineate the risk profile of patients with isolated cerebral or coronary
      ischemia and those with combined disease. The study will also evaluate current management
      status of those patients and any unmet needs.This aim is proposed to be achieved by studying
      3 groups of patients with coronary, cerebral or combined ischemia. Anticipated each group to
      be 1000 patients.
Background: most of available data are designed to show risk profile of either coronary or
      cerebral ischemia, few data compared both risk profiles or tried to outline risk factors for
      combined ischemia.

      The aim is to compare risk profile of isolated coronary, cerebral ischemia or combined
      disease to find out specific profile for each territory affection. Current management of risk
      factors will be documented to find out any unmet needs specially for sicker patients with
      combined ischemia.

      Material and methods: 3 groups of patients representing coronary, cerebral and combined
      ischemia.will be studied.

      Documentation of coronary ischemia will be either by history of coronary care unit admission,
      ECG documenting an infarction or ischemia, other noninvasive testing, previous coronary
      intervention or coronary artery bypass grafting. Documentation of cerebral ischemia will be
      by history, examination for a neurological deficit or any imaging modality documenting
      cerebral ischemia (brain CT, MRI or duplex whether for extra or intracranial vessels).

      Risk factor analysis will be for the known risk factors like, age, sex, family history,
      smoking, recurrent events (like more than one coronary event), sedentary life, waist/hip
      ratio, BMI, diabetes(history, duration, current medication and current control status,
      HbA1c), hypertension (history, duration, current drug treatment and current control status).
      hypercholesterolemia (history, duration, drug treatment and control with current evaluation
      of LDL, HDL, TG, ApoB/ApoA), hs-CRP, presence of AF( drug treatment).

      Full patient data will be obtained in a Case Report Form (CRF) based format. CRF format will
      be designed by the steering committee. Investigators at clinics or centers who agree to
      share, will be committed to fulfill this CRF and send electronic form to central workstation
      for database saving.

      Filling the CRF will be based on a single interview between the investigator and the patient,
      and any missing data or investigation that mandates another interview will be allowed to
      complete the CRF within a period of 30 days.

      Center or investigator agreement will be signed first to be involved in the study and to
      receive the CRF.

      All patients will sign a written consent to share in the study.

      Data analysis will be presented as mean or numbers (%). The significance of relation between
      qualitative variables will be analysed by chi-square test or Fisher's exact test as
      indicated. The distribution of means among groups will be analysed by student t testor ANOVA
      as appropriate.

      Correlation between quantitative variables will be studied by correlation coefficient.

      Independent predictors of primary outcomes will be analysed by logistic regression analysis
      and cox regression analysis as indicated.

      .
observational model: Case-Control
time perspective: Cross-Sectional
measure: Incidence of presence and control status for known risk factors (defined by questionnaire from history, clinical examination, laboratory testing) in each group of patients.
time frame: 12 months (after finishing of patients recruitment).
description: Number of patients in each group of having the risk factors and whether each risk factor is controlled or not?
measure: Comparing data of the incidence between groups (statistically) may result in a specific risk profile for combined coronary and cerebral ischemia.
time frame: 12 months, after calculating the incidence of risk factors in each group.
description: Data of the incidence of risk factors will be compared between different group.
measure: Discovering unmet needs in controlling risk factors in our patients
time frame: 24 months, after revising and releasing incidence data, risk factors control will be subjected to analysis and comparison to the standard care.
description: Any management gap for risk factors (defined as under diagnosis, under treatment, or uncontrolled patients) will be recorded .To arise awareness of the health care system (including decision makers and public community) regarding any management gap.
arm group label: Group A
description: Having combined coronary and cerebral ischemia.
arm group label: Group B
description: Having only coronary ischemia
arm group label: group C
description: Having only cerebral ischemia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Bassem E Badr, Doctorate
phone: +201223950548
email: bassemzarif@gmail.com
last name: Marwa M Zaki, BPharm
phone: +20226246160
email: dr.marwamamdouh@ymail.com
citation: Emerging Risk Factors Collaboration; Di Angelantonio E, Kaptoge S, Wormser D, Willeit P, Butterworth AS, Bansal N, O'Keeffe LM, Gao P, Wood AM, Burgess S, Freitag DF, Pennells L, Peters SA, Hart CL, Haheim LL, Gillum RF, Nordestgaard BG, Psaty BM, Yeap BB, Knuiman MW, Nietert PJ, Kauhanen J, Salonen JT, Kuller LH, Simons LA, van der Schouw YT, Barrett-Connor E, Selmer R, Crespo CJ, Rodriguez B, Verschuren WM, Salomaa V, Svardsudd K, van der Harst P, Bjorkelund C, Wilhelmsen L, Wallace RB, Brenner H, Amouyel P, Barr EL, Iso H, Onat A, Trevisan M, D'Agostino RB Sr, Cooper C, Kavousi M, Welin L, Roussel R, Hu FB, Sato S, Davidson KW, Howard BV, Leening MJ, Leening M, Rosengren A, Dorr M, Deeg DJ, Kiechl S, Stehouwer CD, Nissinen A, Giampaoli S, Donfrancesco C, Kromhout D, Price JF, Peters A, Meade TW, Casiglia E, Lawlor DA, Gallacher J, Nagel D, Franco OH, Assmann G, Dagenais GR, Jukema JW, Sundstrom J, Woodward M, Brunner EJ, Khaw KT, Wareham NJ, Whitsel EA, Njolstad I, Hedblad B, Wassertheil-Smoller S, Engstrom G, Rosamond WD, Selvin E, Sattar N, Thompson SG, Danesh J. Association of Cardiometabolic Multimorbidity With Mortality. JAMA. 2015 Jul 7;314(1):52-60. doi: 10.1001/jama.2015.7008. Erratum In: JAMA. 2015 Sep 15;314(11):1179. Leening, Maarten [corrected to Leening, Maarten J G].
PMID: 26151266
citation: Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L; INTERHEART Study Investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):937-52. doi: 10.1016/S0140-6736(04)17018-9.
PMID: 15364185
citation: Soler EP, Ruiz VC. Epidemiology and risk factors of cerebral ischemia and ischemic heart diseases: similarities and differences. Curr Cardiol Rev. 2010 Aug;6(3):138-49. doi: 10.2174/157340310791658785.
PMID: 21804773
responsible party type: Principal Investigator
investigator affiliation: Egyptian Cerebro-Cardio-Vascular Association
investigator full name: Bassem zarif
investigator title: Consultant cardiologist, Vise president of Egyptian cerebro-cardio-vascular Association
mesh term: Brain Ischemia
mesh term: Cerebral Infarction
mesh term: Myocardial Ischemia
mesh term: Ischemia
sharing ipd: Yes
ipd description: after recruiting sites and investigators.