Skip to content

The effect of Qishen Yiqi dropping pills on myocardial microcirculation in patients with acute myocardial infarction after PCI

The effect of Qishen Yiqi dropping pills on myocardial microcirculation in patients with acute myocardial infarction after PCI

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000659
Enrollment
Unknown
Registered
2025-04-06
Start date
2024-04-24
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Myocardial Infarction

Interventions

experimental group:Qishen Yiqi dropping pills and standard secondary prevention treatment for coronary heart disease
control group:The simulated agent of Qishen Yiqi dropping pills and standard secondary prevention treatment for coronary heart disease

Sponsors

The First Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged =18 years regardless of gender; 2. Diagnosed with acute myocardial infarction (AMI) including ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI); 3. Indicated for PCI and within 24 hours after the completion of PCI; 4. Receiving standard secondary prevention medications for coronary artery disease after PCI; 5. No use of Qishen Yiqi Dropping Pills for at least 2 weeks prior to enrollment; 6. Signed the informed consent form for the study.

Exclusion criteria

Exclusion criteria: 1. Planned revascularization procedures (including stent implantation or coronary artery bypass grafting) in the near future. 2. Heart failure classified as NYHA functional class III or IV cardiogenic shock or requiring inotropic drugs or intra-aortic balloon pump (IABP) support. 3. Severe complications occurring during the PCI procedure. 4. Failure to randomize within 14 days after follow-up MCE shows no improvement in the CSI. 5. Persistent circulatory congestion or valvular heart disease uncorrected by surgery with an anticipated high frequency of hospitalizations or recurrence during follow-up. 6. Aortic stenosis with a valve area <1.5 cm². 7. History of allergy to the study drug or known/suspected contraindications to the study drug. 8. Other causes of angina such as severe aortic valve stenosis or insufficiency coronary arteritis caused by rheumatic fever or other conditions syphilitic aortitis leading to coronary ostial stenosis or occlusion hypertrophic cardiomyopathy or congenital coronary artery anomalies. 9. Occurrence of other severe cardiovascular or cerebrovascular events within the past three months such as stroke or transient ischemic attack. 10. Presence of malignant tumors multi-organ failure or other conditions likely to result in a life expectancy of less than two months. 11. Cognitive impairment substance dependence or severe psychiatric disorders. 12. Intravenous drug abuse. 13. Pregnancy or breastfeeding or plans to conceive or donate eggs during the study period. 14. Inability to comply with follow-up. 15. Concurrent participation in other clinical trials. 16. Inability to understand or complete all follow-up procedures. 17. Any other factors likely to compromise adherence to the study protocol. 18. Deemed unsuitable for participation in this clinical trial for any reason by the investigator.

Design outcomes

Primary

MeasureTime frame
Contrast core Index, CSI;

Secondary

MeasureTime frame
Retinal vascular density;The area of foveal avascular zone;Angina symptom score;Central retinal venular equivalent, CRVE;Central retinal arteriolar equivalent, CRAE;retinal vascular fractal dimension, FD;Arteriole to venule ratio, AVR;

Countries

China

Contacts

Public ContactWei Fangfei

The First Affiliated Hospital of Sun Yat-sen University

fangfeimuxiang@163.com+86 136 7246 8116

Outcome results

None listed

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