Survival Myocardial Area After Acute Myocardial DeathPhase 4NCT03958422
Clinical Study of Cardiomyopeptidin on Postoperative Ischemia-reperfusion Injury in Patients With Primary PCI
A Phase 4 study testing cardiomyopeptidin in people with Survival Myocardial Area After Acute Myocardial Death and Left Ventricular Ejection Fraction, run by Dalian Zhen-Ao Bio-Tech Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Survival Myocardial Area After Acute Myocardial Death, Left Ventricular Ejection Fraction
- What is being tested?
- cardiomyopeptidin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2019to 31 Jan 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- (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;
Show all 17Show fewer
- (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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Being tested
- cardiomyopeptidin
- Keywords
- Acute myocardial infarction, Nuclear magnetic image, Survival myocardial area
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiomyopeptidinDrug
The main component of cardiomyopeptidin is the peptide active substance extracted from the ventricular myocytes of healthy young pigs.
| Study group | Role | What they receive |
|---|---|---|
| Myocardin test group | Experimental | 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. Receives: Drug: cardiomyopeptidin |
| Blank test group | No intervention | Patients in blank test group aren't given the injection of cardiomyopeptidinl before primary percutaneous coronary intervention (PCI) . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial infarct size
Nuclear magnetic imaging focused on the assessment of myocardial infarct size（%）;
Measured: 7±3 days after surgery
Secondary outcomes (9)
Delay enhancement
Nuclear magnetic imaging focused on microcirculation obstruction, myocardial edema area, delayed enhancement
Measured: 7±3 days after surgery
ECG ST-T changes
Interpretation of ST-T changes in leads based on electrocardiogram
Measured: "hour6", "hour12","hour24"after myocardial infarction
Heart function classification
Cardiac function grading of patients with acute myocardial infarction by Killip grading
Measured: "day6", "week4","week12","week24"after surgery
CK（ng/ml）
one of Myocardial enzymes CK-MB(ng/ml)、cTnT(ng/ml)、BNP(pg/ml)
Measured: "hour6", "hour12","hour24" and 7±3 days after myocardial infarction
CK-MB(ng/ml)
one of Myocardial enzymes cTnT(ng/ml)、BNP(pg/ml)
Measured: "hour6", "hour12","hour24" and 7±3 days after myocardial infarction
cTnT(ng/ml)
one of Myocardial enzymes
Measured: "hour6", "hour12","hour24" and 7±3 days after myocardial infarction
BNP(pg/ml)
one of Myocardial enzymes
Measured: "hour6", "hour12","hour24" and 7±3 days after myocardial infarction
Cardiac echocardiography
Left ventricular ejection fraction
Measured: 3days and 1,3,6 monthes after myocardial infarction
Incidence of cardiovascular events
Non-lethal myocardial infarction, all-cause death, revascularization due to angina pectoris, re-hospitalization of acute heart failure
Measured: 7±3 days and 1,3,6 monthes after myocardial infarction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start1 Jun 2019 (estimated)
- Primary completion30 Nov 2019 (estimated)
- Study completion31 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Survival Myocardial Area After Acute Myocardial DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random, controlled, single blind
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalian Zhen-Ao Bio-Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yundai Chen, Study director, cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958422
- Sponsor's protocol ID
- DLZA2019P01
- Status last verified
- Apr 2019
- First submitted
- 18 Apr 2019
- Last updated
- 22 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03958422
- Acronym / sponsor ID
- DLZA2019P01
- Keywords
- Acute myocardial infarction, Nuclear magnetic image, Survival myocardial area
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Dalian Zhen-Ao Bio-Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 31 Jan 2020 (estimated)
- First posted
- 22 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Random, controlled, single blind
| Arm | Type | Receives |
|---|---|---|
| Myocardin test group | Experimental | Drug: cardiomyopeptidinPatients 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. |
| Blank test group | No intervention | –Patients in blank test group aren't given the injection of cardiomyopeptidinl before primary percutaneous coronary intervention (PCI) . |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (17 listed)
- (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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiomyopeptidinThe main component of cardiomyopeptidin is the peptide active substance extracted from the ventricular myocytes of healthy young pigs. | Drug | Myocardin test group |
Primary outcome
Myocardial infarct size
Time frame: 7±3 days after surgery
Nuclear magnetic imaging focused on the assessment of myocardial infarct size（%）;
9 secondary outcomes
Delay enhancement
Time frame: 7±3 days after surgery
ECG ST-T changes
Time frame: "hour6", "hour12","hour24"after myocardial infarction
Heart function classification
Time frame: "day6", "week4","week12","week24"after surgery
CK（ng/ml）
Time frame: "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
cTnT(ng/ml)
Time frame: "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
Cardiac echocardiography
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2019.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yundai Chen study director
cardiology
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cardiomyopeptidin in people with Survival Myocardial Area After Acute Myocardial Death and Left Ventricular Ejection Fraction, run by Dalian Zhen-Ao Bio-Tech Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Geng Qian (13810914587, zouzouyuting@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial infarct size (time frame: 7±3 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2019.