Status:
NOT_YET_RECRUITING
Clinical Evaluation of Aromatic Wentong in the Treatment of Coronary Microvascular Disease
Lead Sponsor:
China-Japan Friendship Hospital
Conditions:
Coronary Microvascular Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Coronary Microvascular Disease (CMD) is a condition where patients experience chest pain (angina) even though their coronary arteries appear normal on angiography. It is common among people with coron...
Eligibility Criteria
Inclusion
- Aged between 18 and 80 years, regardless of gender.
- Clinical symptoms of myocardial ischemia.
- Objective evidence of myocardial ischemia, including:
- ECG changes during chest pain episodes,
- Stress test-induced chest pain symptoms and/or abnormal myocardial blood flow and/or abnormal cardiac wall motion with ischemic ECG changes.
- Coronary angiography (CAG) showing \>50% reduction in the diameter of the epicardial coronary artery.
- QFR \> 0.80 and AMR \> 2.5 mmHg·s/cm.
- Discontinuation of all Chinese medicine interventions for at least two weeks prior to enrollment.
- Provision of informed consent and a signed informed consent form.
Exclusion
- Significant liver or kidney dysfunction, defined as ALT, AST, or blood creatinine levels \>3 times the upper limit of normal.
- Severe cardiac conditions, including heart failure, myocarditis, cardiomyopathy, acute pericarditis, structural heart disease.
- Severe systemic diseases, such as severe mental illness, hematopoietic system disorders, or malignant tumors.
- Suspected or confirmed allergy to the trial drug.
- Individuals deemed by researchers to be unsuitable for participation in the clinical trial.
- Women who are pregnant, planning to become pregnant, or currently lactating.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
528 Patients enrolled
Trial Details
Trial ID
NCT06901570
Start Date
April 1 2025
End Date
July 1 2028
Last Update
April 11 2025
Active Locations (1)
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1
China-Japan Friendship Hospital
Beijing, Chaoyang District, China, 100029