Coronary Microvascular Disease
Conditions
Brief summary
To investigate the efficacy and safety of Qishenyiqi in patients with microvascular angina pectoris. Long-term follow-up of 1 year will be performed to evaluate the effect of Qishenyiqi on coronary flow reserve and adverse cardiovascular events in patients with coronary microvascular disease.
Interventions
DRUGQishenyiqi dripping pills 1 bag, three times a day
Qishenyiqi dripping pills, 1 bag once, three times a day, 12 months
DRUGPlacebo 1 bag, three times a day
Placebo, 1 bag once, three times a day, 12 months
Sponsors
Qilu Hospital of Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks; * Coronary normal or stenosis \< 20%; * Ischemic depression in ST segment during resting or exercise; * Blood flow reserve (CFR) of the anterior descending coronary artery \< 2.0; * Subjects or their guardians agreed to participate in this study.
Exclusion criteria
* Previous myocardial infarction or PCI or CABG treatment; * A history of heart failure; * Severe arrhythmia; * Refractory hypertension or hypertension accompanied by left ventricular wall thickness \> 12 mm; * Familial hypercholesterolemia; * Takayasu arteritis, Kawasaki disease or coronary artery malformation; * Pregnant or nursing, or having the intention to give birth within one year; * Hepatic or renal dysfunction; * Allergic to contrast agents or traditional Chinese medicines; * Patients who participated in clinical research of other drugs within 3 months before being selected.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of coronary flow reserve measured by three-dimensional echocardiography from baseline to 12 months after follow-up | 1 year |
Countries
China
Contacts
Primary ContactPanpan Hao, Dr.
Outcome results
None listed