NCT03958422

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2019

Shorter than P25 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 22, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

May 22, 2019

Status Verified

April 1, 2019

Enrollment Period

6 months

First QC Date

April 18, 2019

Last Update Submit

May 19, 2019

Conditions

Survival Myocardial Area After Acute Myocardial DeathLeft Ventricular Ejection Fraction

Keywords

Acute myocardial infarctionNuclear magnetic imageSurvival myocardial area

Outcome Measures

Primary Outcomes (1)

  • Myocardial infarct size

    Nuclear magnetic imaging focused on the assessment of myocardial infarct size（%）;

    7±3 days after surgery

Secondary Outcomes (9)

  • Delay enhancement

    7±3 days after surgery

  • ECG ST-T changes

    "hour6", "hour12","hour24"after myocardial infarction

  • Heart function classification

    "day6", "week4","week12","week24"after surgery

  • CK（ng/ml）

    "hour6", "hour12","hour24" and 7±3 days after myocardial infarction

  • CK-MB(ng/ml)

    "hour6", "hour12","hour24" and 7±3 days after myocardial infarction

  • +4 more secondary outcomes

Study Arms (2)

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.

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) .

Interventions

cardiomyopeptidinDRUG

The main component of cardiomyopeptidin is the peptide active substance extracted from the ventricular myocytes of healthy young pigs.

Myocardin test group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) Sign the informed consent form;
  • \) Age ≥ 18 and ≤ 80 years old, gender is not limited;
  • \) Defining the diagnosis of acute myocardial infarction, with indications for direct coronary intervention;
  • \) 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 ;
  • \) The course of disease is ≤12 hours or accompanied by cardiogenic shock or heart failure (onset \>12h).

You may not qualify if:

  • (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;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

cardiomyopeptidin

Study Officials

  • Yundai Chen

    cardiology

    STUDY DIRECTOR

Central Study Contacts

Geng Qian

CONTACT

13810914587zouzouyuting@163.com

Kai Yan

CONTACT

13940849959ykanna_715@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Random, controlled, single blind
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2019

First Posted

May 22, 2019

Study Start

June 1, 2019

Primary Completion

November 30, 2019

Study Completion

January 31, 2020

Last Updated

May 22, 2019

Record last verified: 2019-04