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出境医 / 临床实验 / Clinical Study of Cardiomyopeptidin on Postoperative Ischemia-reperfusion Injury in Patients With Primary PCI

Clinical Study of Cardiomyopeptidin on Postoperative Ischemia-reperfusion Injury in Patients With Primary PCI

Study Description
Brief Summary:
In this study, advanced techniques of myocardial nuclear magnetic perfusion scanning were used to quantitatively assess infarct size after acute myocardial infarction, saved viable myocardium, and microcirculatory obstruction area. Objectively and quantitatively evaluate early use of cardiomyopeptidin for direct PCI of ST-segment elevation myocardial infarction. After the improvement of microcirculation and increase the intervention effect of viable myocardium.

Condition or disease Intervention/treatment Phase
Survival Myocardial Area After Acute Myocardial Death Left Ventricular Ejection Fraction Drug: cardiomyopeptidin Phase 4

Detailed Description:
This is a prospective, randomized, controlled, single-blind, single-center clinical trial. Patients with ST-segment elevation myocardial infarction (STEMI) who were admitted in the People's Liberation Army General Hospital were equally randomized to receive either cardiomyopeptidin or placebo, and patients in cardiomyopeptidin group are given the injection of cardiomyopeptidinl before primary percutaneous coronary intervention (PCI) and intravenous infusion of cardiomyopeptidin was performed 3 days after primary PCI. Myocardial perfusion flow grade was evaluated by the result of primary PCI. Myocardial infarct size, microvascular obstruction and salvage myocardium were evaluated by enhanced cardiac magnetic resonance (CMR). Major adverse cardiovascular events (nonfatal myocardial infarction, all-cause death, hospitalization for acute heart failure, and revascularization for angina) were observed during the 6-month follow-up. CMR is performed to evaluate the effect of cardiomyopeptidin before primary PCI on myocardial salvage and microcirculation perfusion in patients with STEMI.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Random, controlled, single blind
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Single-blind, Controlled Clinical Trial of Cardiomyopeptidin Intervention in Patients With Acute ST-segment Elevation Myocardial Infarction Undergoing Direct PCI After Ischemia-reperfusion Injury
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : January 31, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Myocardin test group
Patients in cardiomyopeptidin group are given the injection of cardiomyopeptidinl before primary percutaneous coronary intervention (PCI) and intravenous infusion of cardiomyopeptidin was performed 3 days after primary PCI.
 Drug: cardiomyopeptidin
The main component of cardiomyopeptidin is the peptide active substance extracted from the ventricular myocytes of healthy young pigs.
No Intervention: Blank test group
Patients in blank test group aren't given the injection of cardiomyopeptidinl before primary percutaneous coronary intervention (PCI) .
Outcome Measures
Primary Outcome Measures :
  1. Myocardial infarct size [ Time Frame: 7±3 days after surgery ]
    Nuclear magnetic imaging focused on the assessment of myocardial infarct size（%）;


Secondary Outcome Measures :
  1. Delay enhancement [ Time Frame: 7±3 days after surgery ]
    Nuclear magnetic imaging focused on microcirculation obstruction, myocardial edema area, delayed enhancement

  2. ECG ST-T changes [ Time Frame: "hour6", "hour12","hour24"after myocardial infarction ]
    Interpretation of ST-T changes in leads based on electrocardiogram

  3. Heart function classification [ Time Frame: "day6", "week4","week12","week24"after surgery ]
    Cardiac function grading of patients with acute myocardial infarction by Killip grading

  4. CK（ng/ml） [ Time Frame: "hour6", "hour12","hour24" and 7±3 days after myocardial infarction ]
    one of Myocardial enzymes CK-MB(ng/ml)、cTnT(ng/ml)、BNP(pg/ml)

  5. CK-MB(ng/ml) [ Time Frame: "hour6", "hour12","hour24" and 7±3 days after myocardial infarction ]
    one of Myocardial enzymes cTnT(ng/ml)、BNP(pg/ml)

  6. cTnT(ng/ml) [ Time Frame: "hour6", "hour12","hour24" and 7±3 days after myocardial infarction ]
    one of Myocardial enzymes

  7. BNP(pg/ml) [ Time Frame: "hour6", "hour12","hour24" and 7±3 days after myocardial infarction ]
    one of Myocardial enzymes

  8. Cardiac echocardiography [ Time Frame: 3days and 1,3,6 monthes after myocardial infarction ]
    Left ventricular ejection fraction

  9. Incidence of cardiovascular events [ Time Frame: 7±3 days and 1,3,6 monthes after myocardial infarction ]
    Non-lethal myocardial infarction, all-cause death, revascularization due to angina pectoris, re-hospitalization of acute heart failure


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1) Sign the informed consent form;
  • 2) Age ≥ 18 and ≤ 80 years old, gender is not limited;
  • 3) Defining the diagnosis of acute myocardial infarction, with indications for direct coronary intervention;
  • 4) Ischemic chest pain lasts for more than 30 minutes and adjacent ST or 2 leads of more than 2 or more leads (limb lead ≥ 0.1 mV, chest lead ≥ 0.2 mV) with or without elevated myocardial enzyme levels ;
  • 5) The course of disease is ≤12 hours or accompanied by cardiogenic shock or heart failure (onset >12h).

Exclusion Criteria:

  • (1) Cardiogenic shock, Killip III-IV grade, papillary muscle rupture, interventricular septal perforation, ventricular ventricular fibrillation and electrical cardioversion, and III degree AVB implantation of temporary pacemaker before PCI;
  • (2) LVEF ≤ 30%;
  • (3) Previous history of PCI and CABG history;
  • (4) acute and chronic infectious diseases (severe pneumonia, etc.);
  • (5) Recent history of hemorrhagic stroke (within six months);
  • (6) Combining liver and kidney dysfunction caused by various reasons;
  • (7) History of valvular heart disease;
  • (8) Congenital heart disease and pulmonary hypertension;
  • (9) History of various types of cardiomyopathy;
  • (10) bleeding and other thrombotic diseases;
  • (11) severe anemia, thrombocytopenia and other blood system diseases;
  • (12) Patients with malignant tumors, autoimmune diseases, and various causes of glucocorticoids and immunosuppressive agents;
  • (13) Patients with a history of drug allergy, allergic diseases or allergies, or patients who are allergic to any of the ingredients in this product;
  • (14) Patients with severe mental or neurological diseases;
  • (15) pregnant women, lactating women, and subjects with a pregnancy plan during the trial;
  • (16) According to the investigator's judgment, the subject is unable to complete the study or may not be able to comply (for administrative reasons or other reasons) the subjects required for this study.
  • (17) Patients who have participated in other clinical trials in the past 3 months.Researchers believe that it is not appropriate to participate in this clinical trial.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Geng Qian 13810914587 zouzouyuting@163.com
Contact: Kai Yan 13940849959 ykanna_715@163.com

Sponsors and Collaborators
Dalian Zhen-Ao Bio-Tech Co., Ltd.
Investigators
Layout table for investigator information
Study Director: Yundai Chen cardiology
Tracking Information
First Submitted Date  ICMJE April 18, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date May 22, 2019
Estimated Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2019) 		Myocardial infarct size [ Time Frame: 7±3 days after surgery ]
Nuclear magnetic imaging focused on the assessment of myocardial infarct size（%）;
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2019)
  • Delay enhancement [ Time Frame: 7±3 days after surgery ]
    Nuclear magnetic imaging focused on microcirculation obstruction, myocardial edema area, delayed enhancement
  • ECG ST-T changes [ Time Frame: "hour6", "hour12","hour24"after myocardial infarction ]
    Interpretation of ST-T changes in leads based on electrocardiogram
  • Heart function classification [ Time Frame: "day6", "week4","week12","week24"after surgery ]
    Cardiac function grading of patients with acute myocardial infarction by Killip grading
  • CK（ng/ml） [ Time Frame: "hour6", "hour12","hour24" and 7±3 days after myocardial infarction ]
    one of Myocardial enzymes CK-MB(ng/ml)、cTnT(ng/ml)、BNP(pg/ml)
  • CK-MB(ng/ml) [ Time Frame: "hour6", "hour12","hour24" and 7±3 days after myocardial infarction ]
    one of Myocardial enzymes cTnT(ng/ml)、BNP(pg/ml)
  • cTnT(ng/ml) [ Time Frame: "hour6", "hour12","hour24" and 7±3 days after myocardial infarction ]
    one of Myocardial enzymes
  • BNP(pg/ml) [ Time Frame: "hour6", "hour12","hour24" and 7±3 days after myocardial infarction ]
    one of Myocardial enzymes
  • Cardiac echocardiography [ Time Frame: 3days and 1,3,6 monthes after myocardial infarction ]
    Left ventricular ejection fraction
  • Incidence of cardiovascular events [ Time Frame: 7±3 days and 1,3,6 monthes after myocardial infarction ]
    Non-lethal myocardial infarction, all-cause death, revascularization due to angina pectoris, re-hospitalization of acute heart failure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study of Cardiomyopeptidin on Postoperative Ischemia-reperfusion Injury in Patients With Primary PCI
Official Title  ICMJE A Randomized, Single-blind, Controlled Clinical Trial of Cardiomyopeptidin Intervention in Patients With Acute ST-segment Elevation Myocardial Infarction Undergoing Direct PCI After Ischemia-reperfusion Injury
Brief Summary In this study, advanced techniques of myocardial nuclear magnetic perfusion scanning were used to quantitatively assess infarct size after acute myocardial infarction, saved viable myocardium, and microcirculatory obstruction area. Objectively and quantitatively evaluate early use of cardiomyopeptidin for direct PCI of ST-segment elevation myocardial infarction. After the improvement of microcirculation and increase the intervention effect of viable myocardium.
Detailed Description This is a prospective, randomized, controlled, single-blind, single-center clinical trial. Patients with ST-segment elevation myocardial infarction (STEMI) who were admitted in the People's Liberation Army General Hospital were equally randomized to receive either cardiomyopeptidin or placebo, and patients in cardiomyopeptidin group are given the injection of cardiomyopeptidinl before primary percutaneous coronary intervention (PCI) and intravenous infusion of cardiomyopeptidin was performed 3 days after primary PCI. Myocardial perfusion flow grade was evaluated by the result of primary PCI. Myocardial infarct size, microvascular obstruction and salvage myocardium were evaluated by enhanced cardiac magnetic resonance (CMR). Major adverse cardiovascular events (nonfatal myocardial infarction, all-cause death, hospitalization for acute heart failure, and revascularization for angina) were observed during the 6-month follow-up. CMR is performed to evaluate the effect of cardiomyopeptidin before primary PCI on myocardial salvage and microcirculation perfusion in patients with STEMI.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Random, controlled, single blind
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Survival Myocardial Area After Acute Myocardial Death
  • Left Ventricular Ejection Fraction
Intervention  ICMJE Drug: cardiomyopeptidin
The main component of cardiomyopeptidin is the peptide active substance extracted from the ventricular myocytes of healthy young pigs.
Study Arms  ICMJE
  • Experimental: Myocardin test group
    Patients in cardiomyopeptidin group are given the injection of cardiomyopeptidinl before primary percutaneous coronary intervention (PCI) and intravenous infusion of cardiomyopeptidin was performed 3 days after primary PCI.
    Intervention: Drug: cardiomyopeptidin
  • No Intervention: Blank test group
    Patients in blank test group aren't given the injection of cardiomyopeptidinl before primary percutaneous coronary intervention (PCI) .
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 19, 2019) 		160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2020
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1) Sign the informed consent form;
  • 2) Age ≥ 18 and ≤ 80 years old, gender is not limited;
  • 3) Defining the diagnosis of acute myocardial infarction, with indications for direct coronary intervention;
  • 4) Ischemic chest pain lasts for more than 30 minutes and adjacent ST or 2 leads of more than 2 or more leads (limb lead ≥ 0.1 mV, chest lead ≥ 0.2 mV) with or without elevated myocardial enzyme levels ;
  • 5) The course of disease is ≤12 hours or accompanied by cardiogenic shock or heart failure (onset >12h).

Exclusion Criteria:

  • (1) Cardiogenic shock, Killip III-IV grade, papillary muscle rupture, interventricular septal perforation, ventricular ventricular fibrillation and electrical cardioversion, and III degree AVB implantation of temporary pacemaker before PCI;
  • (2) LVEF ≤ 30%;
  • (3) Previous history of PCI and CABG history;
  • (4) acute and chronic infectious diseases (severe pneumonia, etc.);
  • (5) Recent history of hemorrhagic stroke (within six months);
  • (6) Combining liver and kidney dysfunction caused by various reasons;
  • (7) History of valvular heart disease;
  • (8) Congenital heart disease and pulmonary hypertension;
  • (9) History of various types of cardiomyopathy;
  • (10) bleeding and other thrombotic diseases;
  • (11) severe anemia, thrombocytopenia and other blood system diseases;
  • (12) Patients with malignant tumors, autoimmune diseases, and various causes of glucocorticoids and immunosuppressive agents;
  • (13) Patients with a history of drug allergy, allergic diseases or allergies, or patients who are allergic to any of the ingredients in this product;
  • (14) Patients with severe mental or neurological diseases;
  • (15) pregnant women, lactating women, and subjects with a pregnancy plan during the trial;
  • (16) According to the investigator's judgment, the subject is unable to complete the study or may not be able to comply (for administrative reasons or other reasons) the subjects required for this study.
  • (17) Patients who have participated in other clinical trials in the past 3 months.Researchers believe that it is not appropriate to participate in this clinical trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03958422
Other Study ID Numbers  ICMJE DLZA2019P01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Dalian Zhen-Ao Bio-Tech Co., Ltd.
Study Sponsor  ICMJE Dalian Zhen-Ao Bio-Tech Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Yundai Chen cardiology
PRS Account Dalian Zhen-Ao Bio-Tech Co., Ltd.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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