Status:
UNKNOWN
Clinical Study on the Effect of Zhenyuan Capsule on Cardiopulmonary Function in Patients With SCAD
Lead Sponsor:
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Conditions:
Stable Coronary Heart Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
A randomized, double-blind, placebo trial was adopted, and cardiopulmonary exercise load test (CPET) was used to detect peak oxygen uptake (PeakVO2) and exercise metabolic equivalent (METs) to confirm...
Eligibility Criteria
Inclusion
- Results of coronary angiography or spiral CT:Patients with coronary artery stenosis ≥ 50%, or with a clear history of myocardial infarction, or stable condition more than one month after ACS treatment (percutaneous coronary intervention therapy, PCI, coronary artery bypass graft, CABG)；
- LVEF≥40%；
- Angina grade Ⅰ-Ⅱ (CCS grade);
- The syndrome differentiation of traditional Chinese medicine is the syndrome of qi deficiency and blood stasis；
- 18 years old ≤ age ≤ 75 years old；
- In accordance with the risk stratification of cardiac rehabilitation in patients with coronary heart disease, the patients with moderate and low risk can carry out cardiopulmonary rehabilitation by exercise；
- Those who sign the informed consent form.
Exclusion
- Patients with acute myocardial infarction or unstable angina pectoris, or within one month after PCI or CABG;
- Patients with absolute and relative contraindications in accordance with cardiopulmonary exercise test;
- Patients who took Zhenyuan capsule in the past 1 month or participated in other clinical trials in the past 1 month；
- Renal insufficiency, serum creatinine \> 2.5mg / dl in male and \> 2.0mg/dl in female；
- Patients with obvious liver disease or both ALT and AST were 3 times higher than the normal upper limit；
- New York heart function (NYHA) grade IV, or patients with recurrent malignant arrhythmias;
- Complicated with chronic obstructive pulmonary disease or even respiratory failure, or complicated with pulmonary infection;
- Diabetic patients with random blood glucose ≥ 13.7mmol/L or glycosylated hemoglobin ≥ 9.5%;
- Pregnant or preparing pregnant women, lactating women;
- Patients with acute cerebrovascular diseases; malignant tumors or patients with life expectancy of less than 1 year; patients with severe hematopoietic diseases; patients with severe mental illness;
- For those who are allergic to the known ingredients of the drug.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04421287
Start Date
June 1 2020
End Date
December 1 2021
Last Update
June 9 2020
Active Locations (1)
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1
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, China, 100091