Presentation on the efficacy and safety of Kuanxiong aerosol in improving exercise tolerance in patients with coronary heart disease and angina pectoris

Phase 1

• Conditions: coronary heart disease and angina pectoris

• Registration Number: ITMCTR2000003106
• Lead Sponsor: Guangdong Provincial Hospital of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

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

Inclusion Criteria

1. Diagnosis of coronary heart disease by coronary CT or coronary angiography;
2. Age 18-75 years old, no lower limb dysfunction, can complete cardiopulmonary exercise test;
3. Satisfy one of the following three items:
(1) coronary CT or coronary angiography indicates 50% -80% of coronary stenosis, but no PCI;
(2) PCI, coronary CT or coronary The angiography showed that other non-intervention coronary stenosis was 50% -80%, and no PCI treatment was performed.
(3) No obvious stenosis after PCI, but chest tightness and chest pain symptoms;
4. Excessive chest tightness, palpitations, chest and back pain, shortness of breath, and heart discomfort, exacerbated after the activity, and the Seattle Angina Pectoris Scale SAQ, Angina Pectoris Frequency Dimension (AF) score <= 80
5. Maximum oxygen uptake VO2 (l / min) maximum value / expected value% < 84%;
6. Subjects were informed and voluntarily signed informed consent.

Exclusion Criteria

1. Patients with revascularization plan within 1 month;
2. Canadian Cardiovascular Association (CCS) patients with grade 4 stable angina;
3. Uncontrolled hypertension (systolic blood pressure> 180mmHg or diastolic blood pressure> 100mmHg), although patients are undergoing antihypertensive treatment;
4. NYHA Class IV or LVEF < 30% of patients;
5. Patients with coronary heart disease and atrial fibrillation;
6. Clinically significant comorbidities, including liver dysfunction (whose ALT or AST levels are more than 2 times higher than normal), renal impairment (serum creatinine levels are more than 2 times higher than normal), history of cerebral hemorrhage or epilepsy Patients who need anticonvulsants;
7. Myocardial infarction occurred 1 month before the start of the research project;
8. Patients with acute coronary syndrome confirmed by examination and rheumatic heart disease, dilated heart disease, severe aortic stenosis and hyperthyroidism;
9. Patients with hemoglobin below 90 g / L;
10. Intermittent claudication, or those unable to participate in cardiopulmonary function assessment due to severe leg pain;
11. ECG shows ST segment elevation over 2mm;
12. Patients participating in any other clinical research or taking their research drug within 30 days;
13. People with known or suspected allergies or allergies to the study drug;
14. Drug abusers: Patients have a recent (in the past 2 years) history of alcohol abuse or a known history of drug dependence;
15. Patients with malignant tumors and mental illness;
16. Patients who the investigator determined were not eligible to participate in the study.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Supplementation / expected value of maximum oxygen uptake VO2 (l / min)%;

Secondary Outcome Measures

Name	Time	Method
VSAQ;CCS;SF-36;VAS;SAQ;Maximum oxygen uptake;the frequency of angina pectoris per week;Number of steps exercised by the subject daily;Maximal cardiac output;Implementation of exercise prescriptions;Oxygen threshold oxygen uptake;METS;NYHA;Anaerobic threshold / maximum oxygen uptake%;Nitroglycerin usage;