A single center, prospective, randomized, blank controlled clinical study to evaluate cardiopulmonary exercise test and exercise tolerance changes in patients with stable coronary heart disease after taking Guanxining tablets

Beijing Hospital of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•(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.

•(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.

发起方