A randomized controlled study on the intervention of Shen Qi Yang Xin Formula in stable coronary heart disease

Early Phase 1

• Conditions: stable coronary heart disease

• Registration Number: ITMCTR2024000215
• Lead Sponsor: Xiyuan Hospital, China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

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

Inclusion Criteria

(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.

Exclusion Criteria

(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.

Study & Design

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