Coronary Microvascular Disease Clinical Trial
Official title:
The Efficacy and Safety of Tongxinluo Capsule in Patients With Coronary Microvascular Disease
Verified date | January 2020 |
Source | Qilu Hospital of Shandong University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To investigate the efficacy and safety of Tongxinluo in patients with microvascular angina pectoris. Long-term follow-up of 1 to 5 years will be performed to evaluate the effect of Tongxinluo on long-term adverse cardiovascular events in patients with coronary microvascular disease.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | January 2025 |
Est. primary completion date | January 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks; 2. Coronary normal or stenosis < 20%; 3. Ischemic depression in ST segment during resting or exercise; 4. Blood flow reserve (CFR) of the anterior descending coronary artery < 2.0; 5. Subjects or their guardians agreed to participate in this study. Exclusion Criteria: 1. Previous myocardial infarction or PCI or CABG treatment; 2. A history of heart failure or LVEF < 50%; 3. Severe arrhythmia; 4. Myocarditis, Pericardium Disease, Valvular Disease, or Cardiomyopathy; 5. A history of stroke within half a year; 6. Diabetes difficult to control; 7. Refractory hypertension or hypertension accompanied by left ventricular wall thickness > 12 mm; 8. Familial hypercholesterolemia; 9. Takayasu arteritis, Kawasaki disease or coronary artery malformation; 10. Pregnant or nursing, or having the intention to give birth within one year; 11. Hepatic or renal dysfunction; 12. Other diseases which may cause serious risks to patients; 13. Requiring warfarin anticoagulant therapy; Taking potassium channel opener, CCB, ACEI drugs or traditional Chinese medicines; 14. Allergic to contrast agents or blood products; 15. Patients who participated in clinical research of other drugs within 3 months before being selected. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Qilu Hospital of Shandong University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes of Coronary Flow Reserve | 1 year |
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