Low ejection fraction coronary heart disease
Conditions
Interventions
Treatment group:During coronary artery bypass grafting, the subjects were treated with fine stem cell patch
Control group:Only Coronary artery bypass grafting.
Sponsors
Fuwai Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) 18~80 years old (including critical value), male or female; 2) It is diagnosed as ischemic cardiomyopathy caused by coronary atherosclerosis, complicated with heart failure and has been treated with the best anti-heart failure treatment; 3) NYHA cardiac function classification is ? ~ ?; 4) At least 4 weeks after the last myocardial infarction; 5) Patients who intend to undergo coronary artery bypass grafting; 6) Color Doppler echocardiography: left ventricular ejection fraction (LVEF) < 35%; 7) Gadolinium-enhanced cardiac magnetic resonance detection: using the 17-segment analysis method suggested by AHA, there are two or more segments in the anterior wall and lateral wall of left ventricle; 8) Gadolinium-enhanced cardiac magnetic resonance detection suggests that the left ventricular myocardial scar volume is = 15%; 9) Subjects who have good compliance, can understand and cooperate with the corresponding inspection operations, are willing to use drugs according to the requirements of the plan and receive follow-up inspection on time; 10) The life expectancy of patients at screening is at least 180 days; 11) Those who voluntarily participate in this study and sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients who meet the indications of coronary artery bypass grafting except those in Article 2 of the inclusion criteria; 2) Patients whose infarct focus is only on the lower wall and have ventricular aneurysm that needs to be removed; 3) Acute myocardial infarction requires emergency surgery; 4) Patients who need to undergo combined surgery, including papillary muscle rupture, severe mitral regurgitation, severe tricuspid regurgitation, or other heart diseases that need surgical treatment, should be ruled out by the researchers; 5) Patients with high risk factors of Coronary artery bypass grafting, including severe cardiopulmonary insufficiency, new cerebral infarction within 3 months, mediastinal disease, severe stenosis or occlusion of carotid artery, who are receiving extracorporeal life support therapy (except IABP); 6) According to the researcher's evaluation, there are active bleeding (gastric ulcer, cerebral hemorrhage, etc.) or hematological diseases [such as anemia; Leukopenia; Thrombocytopenia; Myelodysplastic syndrome; Acute or chronic leukemia; Plasma cell disease (such as multiple myeloma)]; 7) There are uncontrollable arrhythmia or malignant arrhythmia in clinic and the researcher determines that there is a high risk in participating in the study; 8) People with autoimmune diseases (such as rheumatoid arthritis and systemic lupus erythematosus) or allergic to bovine-derived materials; 9) Those who have been allergic to gentamicin in the past; 10) Suffering from malignant tumor, or having any history of malignant tumor within 5 years before screening, except for cervical carcinoma in situ, squamous cell carcinoma of skin or basal cell carcinoma that had been treated for radical treatment in the past; 11) Patients with positive serological virology (HBsAg, HCV antibody, HIV antibody and Treponema pallidum antibody), including hepatitis B virus carriers, patients with stable hepatitis B after drug treatment and patients with cured hepatitis C (HCV-RNA test negative) can be included in the group after being judged qualified by researchers; 12) Those who have participated in any other clinical trials within 3 months before screening; 13) Patients who have implanted pacemakers within 3 months before screening and are not suitable for CMR examination; 14) Female subjects of childbearing age who are breast-feeding or have positive pregnancy test during the screening period; 15) Have a family planning within six months from the signing of the informed consent form to the end of the trial, and are unwilling or unable to take effective contraceptive measures; 16) Suffering from the following diseases that may limit the participation in this study according to the researcher's judgment: for example, serious infection in active period or poor clinical control; Arterial hypertension that is still uncontrolled even after standard treatment; Patients with hypotension; Diabetes with unsatisfactory blood sugar control; 17) Complicated with viral hepatitis, severe active liver disease, abnormal liver function, abnormal renal function or received dialysis treatment within 28 days before operation; 18) Subjects who have been allergic to nuclear magnetic or CT contrast agents in the past; 19) Patients who have received stem cell transplantation in the past year; 20) According to the researcher's judgment, there are diseases that weaken the subject's ability to provide informed consent, such as unstable mental illness, cognitive im
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events and serious adverse events;Color Doppler echocardiography:Left ventricular ejection fraction (LVEF);Gadolinium-enhanced cardiac magnetic resonance;Incidence rate of ventricular arrhythmia; High sensitivity troponin I ;Changes of immunogenicity compared with baseline period;Changes of ultra-long-range electrocardiogram compared with baseline period;Changes of tumor markers compared with screening period;Changes of cytokines subsets compared with baseline period;Changes of vital signs and physical examination compared with baseline period;Changes of 12-lead ECG compared with baseline period;Changes of laboratory tests compared with baseline period;Incidence of adverse events related to stem cell sheet implantation;Changes of lymphocyte subsets;High sensitivity C-reactive protein; | — |
Secondary
| Measure | Time frame |
|---|---|
| High sensitivity troponin I ;Activity tolerance test (6-minute walking test);PET-CT examination of heart;NYHA cardiac function classification of new york Heart Association;Minnesota Heart Failure Quality of Life Questionnaire Score;Incidence of malignant cardiogenic events;all cause mortality; | — |
Countries
China
Contacts
Public ContactZheng Zhe
Fuwai Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed