ITMCTR2024000215尚未招募1 期
A randomized controlled study on the intervention of Shen Qi Yang Xin Formula in stable coronary heart disease
试验速览
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 40 至 75（—）
- 性别
- All
入选标准
- •(1) Meet the diagnostic criteria for stable coronary artery disease, and Coronary CTA or coronary angiography shows a 50%-70% narrowing of the lumen diameter of at least one major branch;
- •(2) Coronary CTA within the past month shows CT-FFR >0.8;
- •(3) Meet the diagnostic criteria of Qi deficiency and blood stasis;
- •(4) Age 30-75 years old, no gender restriction;
- •(5) Volunteer to be tested and sign an informed consent form.
排除标准
- •(1) Acute myocardial infarction or coronary artery revascularization treatment within the last 30 days.
- •(2) Those who have one of the following diseases: a. Hypertension and still high blood pressure after treatment with antihypertensive drugs (systolic blood pressure =160mmHg, diastolic blood pressure =100mmHg); b. Severe malignant arrhythmia, pulmonary heart disease, rheumatoid artery disease, myocarditis, cardiomyopathy, aortic coarctation, pulmonary embolism and other serious diseases.
- •(3) Those with symptoms of chest pain associated with diseases such as hyperthyroidism, ervical spondylosis, bile-cardiac syndrome, esophageal hiatal hernia, neurosis, and menopausal syndrome.
- •(4) Those at risk of severe bleeding.
- •(5) Those with serum ghrelin or serum creatinine >3 times the upper limit of normal reference value.
- •(6) Those with severe hematologic diseases and malignant tumors.
- •(7) Those with one of the following contraindications to coronary CTA: a. Previous history of severe allergic reaction to contrast media; b. Patients who are unable to cooperate with scanning and breath-holding; c. Pregnant women, lactating women, or women of childbearing age with childbearing requirements; d. Clinical signs of life are unstable (e.g., acute myocardial infarction, decompensated heart failure, severe hypotension, etc.); e. Severe renal insufficiency.
- •(8) Persons who are mentally ill or have cognitive dysfunction.
- •(9) Hypersensitivity to the test drug.
- •(10) Participation in other clinical trials within the last 1 month, or oral administration of blood-activating and blood-stasis-relieving herbal preparations.
- •(11) Patients whose coronary CTA images are unavailable or of poor quality for plaque characterization or hydrodynamic analysis.
研究者
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