<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/NCT03296670</url>
  </required_header>
  <id_info>
    <org_study_id>LSG1501104</org_study_id>
    <nct_id>NCT03296670</nct_id>
  </id_info>
  <brief_title>Efficacy of Intracoronary Infusion of Different Medicine in STEMI Patients With CSFP</brief_title>
  <official_title>Intracoronary Infusion of Alprostadil and Nitroglycerin With Targeted Perfusion Microcatheter in STEMI Patients With Coronary Slow Flow Phenomenon</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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 targeted&#xD;
      perfusion catheter in coronary administration on coronary blood flow in STEMI patients with&#xD;
      CSFP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of STEMI therapy is to successfully restore epicardial blood flow. PCI has been&#xD;
      documented as being the most effective method for restoration of epicardial blood flow.&#xD;
      However, stenting does not necessarily equate to epicardial blood flow; not every patient&#xD;
      achieves TIMI 3 flow after successful PCI.&#xD;
&#xD;
      Currently, there are two main types of interventions to improve epicardial blood flow. One is&#xD;
      the mechanical method, which included thrombus aspiration catheter and the distal protective&#xD;
      devices. It has been confirmed that the mechanical method can effectively improve epicardial&#xD;
      and myocardial perfusion in patient with part of large vessels and high burden thrombus. But&#xD;
      for patients with small vessels and no obvious visual thrombus, the efficacy is not&#xD;
      significant.&#xD;
&#xD;
      The other intervention is medicine which included GP IIb/IIIa receptor antagonist, adenosine,&#xD;
      sodium nitroprusside, verapamil etc. Part of the drugs have some effect but the overall&#xD;
      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. TFG and cTFC are applied to evaluate the efficacy of treatment with&#xD;
      Alprostadil or Nitroglycerin on coronary blood flow in STEMI patients with CSFP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2015</start_date>
  <completion_date type="Actual">August 31, 2017</completion_date>
  <primary_completion_date type="Actual">April 28, 2017</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 Flow Grade (TFG)</measure>
    <time_frame>One mins after PCI</time_frame>
    <description>TIMI Flow Grade (TFG)assesses flow in the epicardial arteries</description>
  </primary_outcome>
  <primary_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>
  </primary_outcome>
  <primary_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>
  </primary_outcome>
  <primary_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>
  </primary_outcome>
  <secondary_outcome>
    <measure>LVEF by echocardiography</measure>
    <time_frame>Echocardiography was performed 3-7 days after PCI</time_frame>
    <description>Echocardiographic index includes LVEF</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>ST Segment Elevation Myocardial Infarction</condition>
  <condition>Coronary Slow Flow Phenomenon</condition>
  <arm_group>
    <arm_group_label>alprostadil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>alprostadil,2ug, delivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients with CSFP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>nitroglycerin</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>nitroglycerin,200ug, delivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients with CSFP</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alprostadil</intervention_name>
    <description>alprostadil,2ug, delivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients with CSFP</description>
    <arm_group_label>alprostadil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nitroglycerin</intervention_name>
    <description>Nitroglycerin,200ug, delivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients with CSFP</description>
    <arm_group_label>nitroglycerin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patents with myocardial infarction who have symptom onset within 12h before randomization;&#xD;
        ECG: ≥2 mm ST-segment elevation in 2 contiguous precordial leads or ≥1 mm ST-segment&#xD;
        elevation in 2 contiguous extremity leads ; Corrected TIMI frame counted (cTFC) measured&#xD;
        from the final angiographic imaging after PCI exceeding 40 frames; Signed informed consent&#xD;
        form prior to trial participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Coronary artery bypass surgery (CABG) history; Failed in stents implanting; Severe heart&#xD;
        failure; Cardiogenic shock.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</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>
  <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>September 2017</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>March 11, 2020</last_update_submitted>
  <last_update_submitted_qc>March 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>STEMI</keyword>
  <keyword>CSFP</keyword>
  <keyword>Alprostadil</keyword>
  <keyword>targeted perfusion microcatheter</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>
    <mesh_term>No-Reflow Phenomenon</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03296670
org study id: LSG1501104
nct id: NCT03296670
lead sponsor: 
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 targeted
      perfusion catheter in coronary administration on coronary blood flow in STEMI patients with
      CSFP.
The goal of STEMI therapy is to successfully restore epicardial blood flow. PCI has been
      documented as being the most effective method for restoration of epicardial blood flow.
      However, stenting does not necessarily equate to epicardial blood flow; not every patient
      achieves TIMI 3 flow after successful PCI.

      Currently, there are two main types of interventions to improve epicardial blood flow. One 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 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. TFG and cTFC are applied to evaluate the efficacy of treatment with
      Alprostadil or Nitroglycerin on coronary blood flow in STEMI patients with CSFP.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
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: LVEF by echocardiography
time frame: Echocardiography was performed 3-7 days after PCI
description: Echocardiographic index includes LVEF
arm group label: alprostadil
arm group type: Experimental
description: alprostadil,2ug, delivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients with CSFP
arm group label: nitroglycerin
arm group type: Placebo Comparator
description: nitroglycerin,200ug, delivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients with CSFP
intervention type: Drug
intervention name: Alprostadil
description: alprostadil,2ug, delivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients with CSFP
arm group label: alprostadil
intervention type: Drug
intervention name: Nitroglycerin
description: Nitroglycerin,200ug, delivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients with CSFP
arm group label: nitroglycerin
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ben He, MD,PhD
role: Principal Investigator
affiliation: Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
facility: 
country: China
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.
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: No-Reflow Phenomenon
mesh term: Nitroglycerin
mesh term: Alprostadil