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Clinical study of Yiqi Huoxue Herbs on Improving Exercise Tolerance in patients with Stable Coronary Artery Disease

Phase 4
Recruiting
Conditions
Stable coronary artery disease
Registration Number
ITMCTR2100004540
Lead Sponsor
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

(1) Aged between 18 to 75 years.
(2) Patients with stable coronary artery disease, coronary artery stenosis >= 50% identified by coronary angiography or coronary computed tomography angiography, or with stable clinical condition >= 3 months after percutaneous coronary intervention treatment (with low or moderate risk of sports rehabilitation);
(3) Patients with symptoms of fatigue or shortness of breath , or the typical symptoms of effort angina, or with a history of previous myocardial infarction, or with documented heart failure diagnosis (including heart failure with preserved ejection fraction);
(4) Patients providing written informed consents.

Exclusion Criteria

(1) Left main coronary artery stenosis (5th segment) >= 50% or proximal left anterior descending coronary artery stenosis (6th segment) > 70%;
(2) Severe aortic stenosis, acute aortic dissection, acute myocarditis or pericarditis, aneurysm, severe pulmonary hypertension, acute pulmonary embolism, pulmonary infarction, bullae, emphysema, respiratory failure and other cardiopulmonary diseases, or heart Failure (NYHA >= III);
(3) Acute cerebrovascular disease;
(4) Uncontrolled blood pressure with the systolic blood pressure >= 160mmHg and/or diastolic blood pressure >= 100mmHg;
(5) Uncontrolled arrhythmia with clinical symptoms or hemodynamic disorders;
(6) Severe primary hepatic, renal, hematopoietic system, acute infectious diseases, mental disorders, or other diseases that are not suitable for cardiopulmonary exercise test;
(7) Pregnant, planning to pregnant or lactating women;
(8) Underwent major surgical intervention on the skull or chest and abdomen within 4 weeks and with a bleeding tendency;
(9) Participated in other clinical trials within 1 month;
(10) Allergic to the test drug or its known components.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Peak VO2;AT;
Secondary Outcome Measures
NameTimeMethod
Seattle Angina Questionnaire;VO2/HR;Cardiopulmonary exercise test: the start time and duration of ST-segment depression=1mm in the ECG;METs;VEmax;The Short Form (36) Health Survey;
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