<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/NCT03252665</url>
  </required_header>
  <id_info>
    <org_study_id>16CR1012A</org_study_id>
    <nct_id>NCT03252665</nct_id>
  </id_info>
  <brief_title>Efficacy of Intracoronary Infusion of Different Medicine in STEMI Patients Undergoing Primary PCI</brief_title>
  <official_title>Efficacy of Intracoronary Infusion of Different Medicine With Targeted Perfusion Catheter on Myocardial Perfusion in Patients With STEMI Undergoing Primary PCI:an Open,Prospective,Randomized,Multicenter Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanghai 10th People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai 6th People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ruijin Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>RenJi Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study intends to evaluate the efficacy of different medicine delivering by targed&#xD;
      perfusion catheter incoronary administration on epicardial, myocardial perfusion and clinical&#xD;
      outcomes in STEMI patients undergoing primary PCI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of STEMI therapy is to successfully restore both epicardial blood flow and&#xD;
      myocardial perfusion. PCI has been documented as being the most effective method for&#xD;
      restoration of epicardial blood flow. However, epicardial blood flow does not necessarily&#xD;
      equate to myocardial perfusion; not every patient with TIMI 3 flow after successful PCI&#xD;
      achieves effective myocardial tissue-level perfusion. Although epicardial TIMI 3 flow could&#xD;
      be restored in &gt;90% of STEMI patients undergoing PCI, normalization of myocardial perfusion&#xD;
      was achieved less frequently, with detrimental impacts on survival。 Currently, there are two&#xD;
      main methods of angiographic assessment of myocardial perfusion: TIMI myocardial perfusion&#xD;
      grading (TMPG), described by Gibson et al. and myocardial blush grading (MBG), described by&#xD;
      Van't Hof et al. These established myocardial perfusion parameters, TMPG and MBG, have been&#xD;
      widely used in various important trials and are reported to be highly useful in predicting&#xD;
      clinical outcomes. However, visual assessment of these methods is categorical, subjective,&#xD;
      and operator dependent. TIMI Myocardial Perfusion Frame Count (TMPFC), a novel and objective&#xD;
      method that measures the filling and clearance of contrast in the myocardium using&#xD;
      cine-angiographic frame-counting, was developed by our center to quantify myocardial tissue-&#xD;
      level perfusion and was proved to be a predictive value on clinical prognosis.&#xD;
&#xD;
      Currently, there are two main types of interventions to improve myocardial perfusion . One&#xD;
      kind is the mechanical method, which included thrombus aspiration catheter and the distal&#xD;
      protective devices. It has been confirmed that the mechanical method can effectively improve&#xD;
      epicardial and myocardial perfusion in patient with part of large vessels and high burden&#xD;
      thrombus. But for patients with small vessels and no obvious visual thrombus, the efficacy is&#xD;
      not significant.&#xD;
&#xD;
      The other kind intervention is medicine which included GP IIb/IIIa receptor antagonist ,&#xD;
      adenosine , sodium nitroprusside, verapamil etc. Part of the drugs have some effect but the&#xD;
      overall clinical efficacy is still not satisfied.&#xD;
&#xD;
      The study intends to use targeted perfusion catheter to deliver drug to the distal targeted&#xD;
      blood vessels. TMPFC and TMPG are applied to evaluate the efficacy of treatment with&#xD;
      Nicorandil versus Alprostadil on myocardial tissue-level perfusion in STEMI patients&#xD;
      undergoing primary PCI.&#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">June 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>TIMI Myocardial Perfusion Frame Count (TMPFC)</measure>
    <time_frame>One mins after PCI</time_frame>
    <description>TMPFC is a novel method to standardize and quantify myocardial perfusion by timing the filling and washout of contrast in the myocardium using cine-angiographic frame-counting. Briefly, the first frame of TMPFC was defined as the frame that clearly demonstrated the first appearance of myocardial blush beyond the IRA (F1). The last frame of TMPFC was then defined as the frame where contrast or myocardial blush disappeared (F2). TMPFC is F2-F1 frame counts at a filming rate of 15 frames/sec, or (F2-F1)×2 frame counts at the corrected filming rate of 30 frames/sec</description>
  </primary_outcome>
  <primary_outcome>
    <measure>TIMI Myocardial Perfusion Frame Count (TMPFC)</measure>
    <time_frame>One mins after intracoronary medicine infusion post-PCI</time_frame>
    <description>TMPFC is a novel method to standardize and quantify myocardial perfusion by timing the filling and washout of contrast in the myocardium using cine-angiographic frame-counting. Briefly, the first frame of TMPFC was defined as the frame that clearly demonstrated the first appearance of myocardial blush beyond the IRA (F1). The last frame of TMPFC was then defined as the frame where contrast or myocardial blush disappeared (F2). TMPFC is F2-F1 frame counts at a filming rate of 15 frames/sec, or (F2-F1)×2 frame counts at the corrected filming rate of 30 frames/sec</description>
  </primary_outcome>
  <primary_outcome>
    <measure>TIMI Myocardial Perfusion Grade (TMPG)</measure>
    <time_frame>One mins after PCI</time_frame>
    <description>TMPG is an angiographic measure of myocardial perfusion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>TIMI Myocardial Perfusion Grade (TMPG)</measure>
    <time_frame>One mins after intracoronary medicine infusion post-PCI</time_frame>
    <description>TMPG is an angiographic measure of myocardial perfusion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ST-segment Resolution</measure>
    <time_frame>90 mins after PCI</time_frame>
    <description>Resolution of the initial sum of ST-segment elevation ≥ 70%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial-specific isoenzyme of creatine kinase (CK-MB) enzyme levels peri-PCI</measure>
    <time_frame>Within 0 to 48 hours after enrollment</time_frame>
    <description>Infarct size is measured by the myocardial-specific isoenzyme of creatine kinase (CK-MB) area under the curve, calculated by the linear-trapezoidal method. If the baseline or last value is missing, the corresponding value will be set to zero. For missing values of intermediate time points, linear interpolation is used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TIMI Flow Grade (TFG)</measure>
    <time_frame>One mins after PCI</time_frame>
    <description>TIMI Flow Grade (TFG)assesses flow in the epicardial arteries</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TIMI Flow Grade (TFG)</measure>
    <time_frame>One mins after intracoronary medicine infusion post-PCI</time_frame>
    <description>TIMI Flow Grade (TFG)assesses flow in the epicardial arteries</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TIMI Frame Count (CTFC)</measure>
    <time_frame>One mins after PCI</time_frame>
    <description>CTFC is a continuous measurement assessing flow in the epicardial arteries.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TIMI Frame Count (CTFC)</measure>
    <time_frame>One mins after intracoronary medicine infusion post-PCI</time_frame>
    <description>CTFC is a continuous measurement assessing flow in the epicardial arteries.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wall motion score index (WMSI) and LVEF by echocardiography</measure>
    <time_frame>Echocardiography was performed 3-5 days after PCI</time_frame>
    <description>Echocardiographic index includes WMSI and LVEF</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CMR defined MVO</measure>
    <time_frame>3-5 days post-infarct</time_frame>
    <description>MVO was defined as hypoenhanced area within infracted zone measured by CMR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infarct Size by Cardiac Magnetic Resonance Imaging (CMR)</measure>
    <time_frame>3-5 days post-infarct</time_frame>
    <description>Infarct size (expressed as a percentage of LV myocardial mass) between two groups 3-5 days post-infarct assessed by the extent of late gadolinium enhancement on CMR</description>
  </secondary_outcome>
  <other_outcome>
    <measure>MACE</measure>
    <time_frame>in-hospital (within 14 days)</time_frame>
    <description>MACE includes all cause death, reinfarction, target vessel revascularization, and stroke</description>
  </other_outcome>
  <other_outcome>
    <measure>MACE</measure>
    <time_frame>30 days after randomization</time_frame>
    <description>MACE includes all cause death, reinfarction, target vessel revascularization, and stroke</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>ST Segment Elevation Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>alprostadil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>alprostadil,2ug, dilivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>nicorandil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>nicorandil,2mg, dilivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>nitroglycerin</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>nitroglycerin,200ug, dilivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alprostadil</intervention_name>
    <description>alprostadil,2ug, dilivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients</description>
    <arm_group_label>alprostadil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nicorandil</intervention_name>
    <description>Nicorandil,2mg, dilivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients</description>
    <arm_group_label>nicorandil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nitroglycerin</intervention_name>
    <description>Nitroglycerin,200ug, dilivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients</description>
    <arm_group_label>nitroglycerin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: over 18 or 18 years old, less than 75 years old;&#xD;
&#xD;
          -  Patents with myocardial infarction who have symptom onset within 6h before&#xD;
             randomization;&#xD;
&#xD;
          -  ECG: ≥2 mm ST-segment elevation in 2 contiguous precordial leads or ≥1 mm ST-segment&#xD;
             elevation in 2 contiguous extremity leads ;&#xD;
&#xD;
          -  Signed informed consent form prior to trial participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Evidence of cardiac rupture;&#xD;
&#xD;
          2. ECG: new left bundle branch block;&#xD;
&#xD;
          3. Thrombolysis contradictions:&#xD;
&#xD;
          4. Severe complication&#xD;
&#xD;
               -  Other diseases with life expectancy ≤12 months;&#xD;
&#xD;
               -  Any history of Severe renal or hepatic dysfunction(hepatic failure, cirrhosis,&#xD;
                  portal hypertension and active hepatitis); Neutropenia, thrombocytopenia ; Known&#xD;
                  acute pancreatitis;&#xD;
&#xD;
               -  Known acute pericarditis and/or subacute bacterial endocarditis;&#xD;
&#xD;
               -  Arterial aneurysm, arterial/venous malformation and aorta dissection;&#xD;
&#xD;
          5. Complex heart condition&#xD;
&#xD;
               -  Cardiogenic shock(SBP &lt;90 mmHg after fluid infusion or SBP&lt;100 mmHg after&#xD;
                  vasoactive drugs);&#xD;
&#xD;
               -  PCI within previous 1 month or Previous coronary-artery bypass surgery(CABG);&#xD;
&#xD;
               -  Previously known multivessel coronary artery disease not suitable for&#xD;
                  revascularization;&#xD;
&#xD;
               -  Hospitalisation for cardiac reason within past 48 hours;&#xD;
&#xD;
          6. Not suitable for clinical trial&#xD;
&#xD;
               -  Inclusion in another clinical trial;&#xD;
&#xD;
               -  Previous enrolment in this study or treatment with an investigational drug or&#xD;
                  device under another study protocol in the past 7 days;&#xD;
&#xD;
               -  Pregnancy or lactating;&#xD;
&#xD;
               -  Body weight &lt;40kg or &gt;125kg;&#xD;
&#xD;
               -  Known hypersensitivity to any drug that may appear in the study;&#xD;
&#xD;
               -  Inability to follow the protocol and comply with follow-up requirements or any&#xD;
                  other reason that the investigator feels would place the patient at increased&#xD;
                  risk.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ben He, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ben He, MD,PhD</last_name>
    <phone>68383609</phone>
    <email>heben1025@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ren Ji Hospital Afflited to School of Medicine, Shanghai Jiao Tong University</name>
      <address>
        <city>ShangHai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Ding S, Pu J, Qiao ZQ, Shan P, Song W, Du Y, Shen JY, Jin SX, Sun Y, Shen L, Lim YL, He B. TIMI myocardial perfusion frame count: a new method to assess myocardial perfusion and its predictive value for short-term prognosis. Catheter Cardiovasc Interv. 2010 Apr 1;75(5):722-32. doi: 10.1002/ccd.22298.</citation>
    <PMID>19960517</PMID>
  </reference>
  <reference>
    <citation>Gurbel PA, Bliden KP, Butler K, Tantry US, Gesheff T, Wei C, Teng R, Antonino MJ, Patil SB, Karunakaran A, Kereiakes DJ, Parris C, Purdy D, Wilson V, Ledley GS, Storey RF. Randomized double-blind assessment of the ONSET and OFFSET of the antiplatelet effects of ticagrelor versus clopidogrel in patients with stable coronary artery disease: the ONSET/OFFSET study. Circulation. 2009 Dec 22;120(25):2577-85. doi: 10.1161/CIRCULATIONAHA.109.912550. Epub 2009 Nov 18.</citation>
    <PMID>19923168</PMID>
  </reference>
  <reference>
    <citation>Gibson CM, Cannon CP, Murphy SA, Ryan KA, Mesley R, Marble SJ, McCabe CH, Van De Werf F, Braunwald E. Relationship of TIMI myocardial perfusion grade to mortality after administration of thrombolytic drugs. Circulation. 2000 Jan 18;101(2):125-30. doi: 10.1161/01.cir.101.2.125.</citation>
    <PMID>10637197</PMID>
  </reference>
  <reference>
    <citation>van 't Hof AW, Liem A, Suryapranata H, Hoorntje JC, de Boer MJ, Zijlstra F. Angiographic assessment of myocardial reperfusion in patients treated with primary angioplasty for acute myocardial infarction: myocardial blush grade. Zwolle Myocardial Infarction Study Group. Circulation. 1998 Jun 16;97(23):2302-6. doi: 10.1161/01.cir.97.23.2302.</citation>
    <PMID>9639373</PMID>
  </reference>
  <reference>
    <citation>Chinese Society of Cardiology of Chinese Medical Association; Editorial Board of Chinese Journal of Cardiology. [Guideline of non-ST segment elevation acute coronary syndrome]. Zhonghua Xin Xue Guan Bing Za Zhi. 2012 May;40(5):353-67. No abstract available. Chinese.</citation>
    <PMID>22883082</PMID>
  </reference>
  <reference>
    <citation>Kidambi A, Mather AN, Motwani M, Swoboda P, Uddin A, Greenwood JP, Plein S. The effect of microvascular obstruction and intramyocardial hemorrhage on contractile recovery in reperfused myocardial infarction: insights from cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2013 Jun 27;15(1):58. doi: 10.1186/1532-429X-15-58.</citation>
    <PMID>23806080</PMID>
  </reference>
  <reference>
    <citation>Roe MT, Ohman EM, Maas AC, Christenson RH, Mahaffey KW, Granger CB, Harrington RA, Califf RM, Krucoff MW. Shifting the open-artery hypothesis downstream: the quest for optimal reperfusion. J Am Coll Cardiol. 2001 Jan;37(1):9-18. doi: 10.1016/s0735-1097(00)01101-3.</citation>
    <PMID>11153779</PMID>
  </reference>
  <reference>
    <citation>Pu J, Shan P, Ding S, Qiao Z, Jiang L, Song W, Du Y, Shen J, Shen L, Jin S, He B. Gender differences in epicardial and tissue-level reperfusion in patients undergoing primary angioplasty for acute myocardial infarction. Atherosclerosis. 2011 Mar;215(1):203-8. doi: 10.1016/j.atherosclerosis.2010.11.019. Epub 2010 Nov 26.</citation>
    <PMID>21176835</PMID>
  </reference>
  <reference>
    <citation>Pu J, Ding S, Shan P, Qiao Z, Song W, Du Y, Shen J, Jin S, He B. Comparison of epicardial and myocardial perfusions after primary coronary angioplasty for ST-elevation myocardial infarction in patients under and over 75 years of age. Aging Clin Exp Res. 2010 Aug;22(4):295-302. doi: 10.1007/BF03337726. Epub 2009 Dec 1.</citation>
    <PMID>20009495</PMID>
  </reference>
  <reference>
    <citation>Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.</citation>
    <PMID>21670242</PMID>
  </reference>
  <reference>
    <citation>Shen LH, Wan F, Shen L, Ding S, Gong XR, Qiao ZQ, Du YP, Song W, Shen JY, Jin SX, Pu J, Yao TB, Jiang LS, Li WZ, Zhou GW, Liu SW, Han YL, He B. Pharmacoinvasive therapy for ST elevation myocardial infarction in China: a pilot study. J Thromb Thrombolysis. 2012 Jan;33(1):101-8. doi: 10.1007/s11239-011-0657-7.</citation>
    <PMID>22094974</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 14, 2017</last_update_submitted>
  <last_update_submitted_qc>August 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>STEMI</keyword>
  <keyword>myocardial perfusion</keyword>
  <keyword>TMPFC</keyword>
  <keyword>Nicorandil</keyword>
  <keyword>Alprostadil</keyword>
  <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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nicorandil</mesh_term>
    <mesh_term>Nitroglycerin</mesh_term>
    <mesh_term>Alprostadil</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03252665
org study id: 16CR1012A
nct id: NCT03252665
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study intends to evaluate the efficacy of different medicine delivering by targed
      perfusion catheter incoronary administration on epicardial, myocardial perfusion and clinical
      outcomes in STEMI patients undergoing primary PCI.
The goal of STEMI therapy is to successfully restore both epicardial blood flow and
      myocardial perfusion. PCI has been documented as being the most effective method for
      restoration of epicardial blood flow. However, epicardial blood flow does not necessarily
      equate to myocardial perfusion; not every patient with TIMI 3 flow after successful PCI
      achieves effective myocardial tissue-level perfusion. Although epicardial TIMI 3 flow could
      be restored in >90% of STEMI patients undergoing PCI, normalization of myocardial perfusion
      was achieved less frequently, with detrimental impacts on survival。 Currently, there are two
      main methods of angiographic assessment of myocardial perfusion: TIMI myocardial perfusion
      grading (TMPG), described by Gibson et al. and myocardial blush grading (MBG), described by
      Van't Hof et al. These established myocardial perfusion parameters, TMPG and MBG, have been
      widely used in various important trials and are reported to be highly useful in predicting
      clinical outcomes. However, visual assessment of these methods is categorical, subjective,
      and operator dependent. TIMI Myocardial Perfusion Frame Count (TMPFC), a novel and objective
      method that measures the filling and clearance of contrast in the myocardium using
      cine-angiographic frame-counting, was developed by our center to quantify myocardial tissue-
      level perfusion and was proved to be a predictive value on clinical prognosis.

      Currently, there are two main types of interventions to improve myocardial perfusion . One
      kind is the mechanical method, which included thrombus aspiration catheter and the distal
      protective devices. It has been confirmed that the mechanical method can effectively improve
      epicardial and myocardial perfusion in patient with part of large vessels and high burden
      thrombus. But for patients with small vessels and no obvious visual thrombus, the efficacy is
      not significant.

      The other kind intervention is medicine which included GP IIb/IIIa receptor antagonist ,
      adenosine , sodium nitroprusside, verapamil etc. Part of the drugs have some effect but the
      overall clinical efficacy is still not satisfied.

      The study intends to use targeted perfusion catheter to deliver drug to the distal targeted
      blood vessels. TMPFC and TMPG are applied to evaluate the efficacy of treatment with
      Nicorandil versus Alprostadil on myocardial tissue-level perfusion in STEMI patients
      undergoing primary PCI.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: TIMI Myocardial Perfusion Frame Count (TMPFC)
time frame: One mins after PCI
description: TMPFC is a novel method to standardize and quantify myocardial perfusion by timing the filling and washout of contrast in the myocardium using cine-angiographic frame-counting. Briefly, the first frame of TMPFC was defined as the frame that clearly demonstrated the first appearance of myocardial blush beyond the IRA (F1). The last frame of TMPFC was then defined as the frame where contrast or myocardial blush disappeared (F2). TMPFC is F2-F1 frame counts at a filming rate of 15 frames/sec, or (F2-F1)×2 frame counts at the corrected filming rate of 30 frames/sec
measure: TIMI Myocardial Perfusion Frame Count (TMPFC)
time frame: One mins after intracoronary medicine infusion post-PCI
description: TMPFC is a novel method to standardize and quantify myocardial perfusion by timing the filling and washout of contrast in the myocardium using cine-angiographic frame-counting. Briefly, the first frame of TMPFC was defined as the frame that clearly demonstrated the first appearance of myocardial blush beyond the IRA (F1). The last frame of TMPFC was then defined as the frame where contrast or myocardial blush disappeared (F2). TMPFC is F2-F1 frame counts at a filming rate of 15 frames/sec, or (F2-F1)×2 frame counts at the corrected filming rate of 30 frames/sec
measure: TIMI Myocardial Perfusion Grade (TMPG)
time frame: One mins after PCI
description: TMPG is an angiographic measure of myocardial perfusion
measure: TIMI Myocardial Perfusion Grade (TMPG)
time frame: One mins after intracoronary medicine infusion post-PCI
description: TMPG is an angiographic measure of myocardial perfusion
measure: ST-segment Resolution
time frame: 90 mins after PCI
description: Resolution of the initial sum of ST-segment elevation ≥ 70%
measure: Myocardial-specific isoenzyme of creatine kinase (CK-MB) enzyme levels peri-PCI
time frame: Within 0 to 48 hours after enrollment
description: Infarct size is measured by the myocardial-specific isoenzyme of creatine kinase (CK-MB) area under the curve, calculated by the linear-trapezoidal method. If the baseline or last value is missing, the corresponding value will be set to zero. For missing values of intermediate time points, linear interpolation is used.
measure: TIMI Flow Grade (TFG)
time frame: One mins after PCI
description: TIMI Flow Grade (TFG)assesses flow in the epicardial arteries
measure: TIMI Flow Grade (TFG)
time frame: One mins after intracoronary medicine infusion post-PCI
description: TIMI Flow Grade (TFG)assesses flow in the epicardial arteries
measure: TIMI Frame Count (CTFC)
time frame: One mins after PCI
description: CTFC is a continuous measurement assessing flow in the epicardial arteries.
measure: TIMI Frame Count (CTFC)
time frame: One mins after intracoronary medicine infusion post-PCI
description: CTFC is a continuous measurement assessing flow in the epicardial arteries.
measure: Wall motion score index (WMSI) and LVEF by echocardiography
time frame: Echocardiography was performed 3-5 days after PCI
description: Echocardiographic index includes WMSI and LVEF
measure: CMR defined MVO
time frame: 3-5 days post-infarct
description: MVO was defined as hypoenhanced area within infracted zone measured by CMR
measure: Infarct Size by Cardiac Magnetic Resonance Imaging (CMR)
time frame: 3-5 days post-infarct
description: Infarct size (expressed as a percentage of LV myocardial mass) between two groups 3-5 days post-infarct assessed by the extent of late gadolinium enhancement on CMR
measure: MACE
time frame: in-hospital (within 14 days)
description: MACE includes all cause death, reinfarction, target vessel revascularization, and stroke
measure: MACE
time frame: 30 days after randomization
description: MACE includes all cause death, reinfarction, target vessel revascularization, and stroke
arm group label: alprostadil
arm group type: Experimental
description: alprostadil,2ug, dilivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients
arm group label: nicorandil
arm group type: Experimental
description: nicorandil,2mg, dilivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients
arm group label: nitroglycerin
arm group type: Placebo Comparator
description: nitroglycerin,200ug, dilivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients
intervention type: Drug
intervention name: Alprostadil
description: alprostadil,2ug, dilivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients
arm group label: alprostadil
intervention type: Drug
intervention name: Nicorandil
description: Nicorandil,2mg, dilivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients
arm group label: nicorandil
intervention type: Drug
intervention name: Nitroglycerin
description: Nitroglycerin,200ug, dilivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients
arm group label: nitroglycerin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ben He, MD,PhD
role: Principal Investigator
affiliation: Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
last name: Ben He, MD,PhD
phone: 68383609
email: heben1025@hotmail.com
facility: 
country: China
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PMID: 19960517
citation: Gurbel PA, Bliden KP, Butler K, Tantry US, Gesheff T, Wei C, Teng R, Antonino MJ, Patil SB, Karunakaran A, Kereiakes DJ, Parris C, Purdy D, Wilson V, Ledley GS, Storey RF. Randomized double-blind assessment of the ONSET and OFFSET of the antiplatelet effects of ticagrelor versus clopidogrel in patients with stable coronary artery disease: the ONSET/OFFSET study. Circulation. 2009 Dec 22;120(25):2577-85. doi: 10.1161/CIRCULATIONAHA.109.912550. Epub 2009 Nov 18.
PMID: 19923168
citation: Gibson CM, Cannon CP, Murphy SA, Ryan KA, Mesley R, Marble SJ, McCabe CH, Van De Werf F, Braunwald E. Relationship of TIMI myocardial perfusion grade to mortality after administration of thrombolytic drugs. Circulation. 2000 Jan 18;101(2):125-30. doi: 10.1161/01.cir.101.2.125.
PMID: 10637197
citation: van 't Hof AW, Liem A, Suryapranata H, Hoorntje JC, de Boer MJ, Zijlstra F. Angiographic assessment of myocardial reperfusion in patients treated with primary angioplasty for acute myocardial infarction: myocardial blush grade. Zwolle Myocardial Infarction Study Group. Circulation. 1998 Jun 16;97(23):2302-6. doi: 10.1161/01.cir.97.23.2302.
PMID: 9639373
citation: Chinese Society of Cardiology of Chinese Medical Association; Editorial Board of Chinese Journal of Cardiology. [Guideline of non-ST segment elevation acute coronary syndrome]. Zhonghua Xin Xue Guan Bing Za Zhi. 2012 May;40(5):353-67. No abstract available. Chinese.
PMID: 22883082
citation: Kidambi A, Mather AN, Motwani M, Swoboda P, Uddin A, Greenwood JP, Plein S. The effect of microvascular obstruction and intramyocardial hemorrhage on contractile recovery in reperfused myocardial infarction: insights from cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2013 Jun 27;15(1):58. doi: 10.1186/1532-429X-15-58.
PMID: 23806080
citation: Roe MT, Ohman EM, Maas AC, Christenson RH, Mahaffey KW, Granger CB, Harrington RA, Califf RM, Krucoff MW. Shifting the open-artery hypothesis downstream: the quest for optimal reperfusion. J Am Coll Cardiol. 2001 Jan;37(1):9-18. doi: 10.1016/s0735-1097(00)01101-3.
PMID: 11153779
citation: Pu J, Shan P, Ding S, Qiao Z, Jiang L, Song W, Du Y, Shen J, Shen L, Jin S, He B. Gender differences in epicardial and tissue-level reperfusion in patients undergoing primary angioplasty for acute myocardial infarction. Atherosclerosis. 2011 Mar;215(1):203-8. doi: 10.1016/j.atherosclerosis.2010.11.019. Epub 2010 Nov 26.
PMID: 21176835
citation: Pu J, Ding S, Shan P, Qiao Z, Song W, Du Y, Shen J, Jin S, He B. Comparison of epicardial and myocardial perfusions after primary coronary angioplasty for ST-elevation myocardial infarction in patients under and over 75 years of age. Aging Clin Exp Res. 2010 Aug;22(4):295-302. doi: 10.1007/BF03337726. Epub 2009 Dec 1.
PMID: 20009495
citation: Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.
PMID: 21670242
citation: Shen LH, Wan F, Shen L, Ding S, Gong XR, Qiao ZQ, Du YP, Song W, Shen JY, Jin SX, Pu J, Yao TB, Jiang LS, Li WZ, Zhou GW, Liu SW, Han YL, He B. Pharmacoinvasive therapy for ST elevation myocardial infarction in China: a pilot study. J Thromb Thrombolysis. 2012 Jan;33(1):101-8. doi: 10.1007/s11239-011-0657-7.
PMID: 22094974
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Infarction
mesh term: Nicorandil
mesh term: Nitroglycerin
mesh term: Alprostadil