Efficacy evaluation of improving cardiopulmonary exercise tolerance of stable coronary heart disease by activating blood circulation and removing blood stasis

Phase 1

Recruiting

• Conditions: Stable coronary heart disease

• Registration Number: ITMCTR2100004312
• Lead Sponsor: Beijing Hospital of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Aged 18-80 years;
(2) Meet the diagnostic criteria for stable coronary heart disease, coronary artery stenosis confirmed by coronary angiography or coronary CT angiography is >= 50%, or patients with acute coronary syndrome have stable condition >= 3 months after percutaneous coronary intervention (PCI) (low or moderate risk of exercise rehabilitation);
(3) clinical symptoms of chest tightness or chest pain, or exertional angina pectoris, or old history of myocardial infarction, or clinically diagnosed heart failure (including ejection fraction retention heart failure);
(4) Signed the informed consent.

Exclusion Criteria

(1) Patients with acute myocardial infarction, unstable angina pectoris or uncontrolled arrhythmia in the last 3 months;
(2) With severe aortic stenosis, acute aortic dissection, acute myocarditis, pericarditis or aneurysms, severe pulmonary hypertension, acute pulmonary embolism and pulmonary infarction, pulmonary bulla, cardiopulmonary diseases such as emphysema, respiratory failure, or heart failure, cardiac function III level and above);
(3) Patients with acute cerebrovascular disease;
(4) Poor hypertension control (systolic blood pressure >= 160mmHg or diastolic blood pressure >= 100mmHg);
(5) Uncontrolled arrhythmias with clinical symptoms or hemodynamic disturbances;
(6) Patients with abnormal liver function (ALT or AST higher than 2 times the upper limit of normal value), abnormal renal function (CR >3mg/ dL or 265.2umol/ L), or with severe primary diseases of liver, kidney, hematopoietic system, acute infectious diseases, electrolyte disturbance, mental illness, or with other diseases are not suitable for the cardiopulmonary exercise test;
(7) Women who are pregnant, planning to become pregnant or lactating;
(8) Patients who have had major cranial and thoracic and abdominal operations within the last 4 weeks and have bleeding tendency;
(9) Participating in other clinical trials within the last 1 month;
(10) Allergic to the test drug or its ingredients.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak O2;