Clinical Study of Cardiomyopeptidin on Postoperative Ischemia-reperfusion Injury in Patients With Primary PCI
May 19, 2019 updated by: Dalian Zhen-Ao Bio-Tech Co., Ltd.
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
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.
Study Overview
Status
Unknown
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
160
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
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) .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Myocardial infarct size
Time Frame: 7±3 days after surgery
|
Nuclear magnetic imaging focused on the assessment of myocardial infarct size（%）;
|
7±3 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Delay enhancement
Time Frame: 7±3 days after surgery
|
Nuclear magnetic imaging focused on microcirculation obstruction, myocardial edema area, delayed enhancement
|
7±3 days after surgery
|
|
ECG ST-T changes
Time Frame: "hour6", "hour12","hour24"after myocardial infarction
|
Interpretation of ST-T changes in leads based on electrocardiogram
|
"hour6", "hour12","hour24"after myocardial infarction
|
|
Heart function classification
Time Frame: "day6", "week4","week12","week24"after surgery
|
Cardiac function grading of patients with acute myocardial infarction by Killip grading
|
"day6", "week4","week12","week24"after surgery
|
|
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)
|
"hour6", "hour12","hour24" and 7±3 days after myocardial infarction
|
|
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)
|
"hour6", "hour12","hour24" and 7±3 days after myocardial infarction
|
|
cTnT(ng/ml)
Time Frame: "hour6", "hour12","hour24" and 7±3 days after myocardial infarction
|
one of Myocardial enzymes
|
"hour6", "hour12","hour24" and 7±3 days after myocardial infarction
|
|
BNP(pg/ml)
Time Frame: "hour6", "hour12","hour24" and 7±3 days after myocardial infarction
|
one of Myocardial enzymes
|
"hour6", "hour12","hour24" and 7±3 days after myocardial infarction
|
|
Cardiac echocardiography
Time Frame: 3days and 1,3,6 monthes after myocardial infarction
|
Left ventricular ejection fraction
|
3days and 1,3,6 monthes after myocardial infarction
|
|
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
|
7±3 days and 1,3,6 monthes after myocardial infarction
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Yundai Chen, Cardiology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2019
Primary Completion (Anticipated)
November 30, 2019
Study Completion (Anticipated)
January 31, 2020
Study Registration Dates
First Submitted
April 18, 2019
First Submitted That Met QC Criteria
May 19, 2019
First Posted (Actual)
May 22, 2019
Study Record Updates
Last Update Posted (Actual)
May 22, 2019
Last Update Submitted That Met QC Criteria
May 19, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DLZA2019P01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.