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A phase IIa clinical trial of coronary artery bypass grafting concurrent injection of recombinant adenovirus-hepatocyte growth factor in the treatment of ischemic heart disease

Recombinant adenovirus-hepatocyte growth factor in the treatment of ischemic heart disease

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14004898
Enrollment
Unknown
Registered
2014-07-07
Start date
2014-07-10
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic heart disease

Interventions

High dose:Ad-HGF
Low dose:Ad-HGF
Placebo:Placebo

Sponsors

The General Hospital of the People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 35 to 70 years, both male and female; 2. To be with coronary heart disease and with ST elevation myocardial infarction history, myocardial infarction longer than four weeks; 3. Coronary angiography (CAG) showed obvious left main coronary artery lesions (degree of coronary artery stenosis more than 50%; equal to the proximal narrow of the anterior descending branch and cyclotron branch of the left main coronary artery lesions more than 70%; or involving the multiple vascular lesions of anterior descending brance (narrow more than 70%); 4. Left ventricular angiography and echocardiographic shows hint left heart function (ejection fraction less than 40%) with segmental ventricular wall motion abnormalities; 5. The heart type single electron emission computed tomography (ct) scan (SPECT) and PETCT scan showed myocardial infarction area exists perfusion/metabolic don't match; 6. 24 hours dynamic electrocardiogram showed no frequent ventricular premature beat and other arrhythmias; 7. New York heart association (NYHA) heart function class II or III; 8. To be with normal cognitive ability, willing to take part in the trial and complete the follow-up; signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Not suit for coronary artery bypass grafting operation; 2. To be complicated with systematic active infection; 3. To be with severe liver and kidney dysfunction (ALT more than 135mmol/L, Cr more than 200umol/L) or COPD; 4. To be complicated with hepatitis B or C patient or career; 5. To be with obvious bleeding trend as well as blood disease; 6. To be complicated with tumor or end stage disease; 7. The expected life shorter than 6 months; 8. To be complicated with heart valves or left ventricular aneurysm or other disease need surgery; 9. To be with hyperplastic retinopathy history; 10. alcohol abuse or drug in past three months; 11. Pregnancy woman; 12. To be complicated with cerebrovascular disease include cerebral infarction and cerebral hemorrhage history; 13. Took part in and accepted other drug trial.

Design outcomes

Primary

MeasureTime frame
heart function;Myocardial perfusion/metabolism;Range of myocardial infarctio;

Secondary

MeasureTime frame
Severe adverse events at month 3 and 6;NYHA, 6 minutes walking test, quality of life;Cardiac contraction ability, Ventricular wall thickness;

Countries

China

Contacts

Public ContactGao Changqing
gaochq301@yahoo.com+86 13801182232

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026