Microvascular Angina Intervention With Compound Danshen Dripping Pill (MAIDS)

Launched by QILU HOSPITAL OF SHANDONG UNIVERSITY · Oct 15, 2023

Keywords

ClinConnect Summary

The MAIDS trial is studying the effects of a traditional Chinese medicine called Compound Danshen Dropping Pill on patients with microvascular angina, which is a type of chest pain caused by problems in the small blood vessels of the heart. This study aims to see if the pill can improve blood flow and reduce the number of chest pain episodes that people experience during physical activity. Participants in the trial will be randomly assigned to receive either the actual medication or a placebo (a sugar pill that looks the same but has no treatment effect) for six months, taking three doses a day.

To be eligible for the trial, participants should be between 30 and 75 years old, have typical symptoms of exertional chest pain, and be able to confirm their condition through specific heart tests. Those with certain other heart or health issues, pregnant or breastfeeding women, and those involved in other clinical studies will not be able to participate. Throughout the study, participants will have follow-up visits every two months to monitor their progress and any changes in their symptoms. This trial is currently recruiting participants, so it’s an opportunity for those who qualify to potentially benefit from a new treatment option.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • 1. with typical symptoms of exertional angina;
• • 2. coronary CTA or angiography with normal coronary artery or \<50% stenosis, or \<50% residual coronary stenosis after revascularization;
• • 3. resting electrocardiogram or During exercise stress, it was found that the ST segment had an ischemic downward shift (the horizontal or downward slope after the J-point shift \> 0.1 mv, lasting 0.08 s);
• • 4. Transthoracic ultrasound examination of blood in the anterior descending coronary artery before and after intravenous injection of adenosine Flow reserve check CFR\<2.5;
• • 5. The patient himself agrees to participate in this study.
• • Exclusion criteria
• • 1. Less than 30 years old or more than 75 years old;
• • 2. Have a history of carotid endarterectomy or stent implantation, and have a history of stroke;
• • 3. Myocarditis, pericardial disease, valvular disease, cardiomyopathy;
• • 4. Difficult to control diabetes mellitus (fasting blood glucose\>7.0 mmol/L);
• • 5. Uncontrolled hypertension (SBP\>150 mmHg and/or DBP\>90 mmHg);
• • 6. Familial hypercholesterolemia;
• • 7. Multiple Takayasu arteritis;
• • 8. Those who are pregnant or lactating, or have fertility intention within one year, or have not taken effective contraceptive measures during the childbearing period;
• • 9. Abnormal liver function (the level of serum GPT is 3.0 times higher than the upper limit of normal value) or abnormal renal function (the level of serum creatinine is more than 2 mg/dl);
• • 10. Other respiratory, digestive, blood, infection, immunity, endocrine, neuropsychiatric, tumor diseases with clinical significance that may cause serious danger to patients;
• • 11. Taking traditional Chinese medicine preparations of K channel opener, promoting blood circulation and removing blood stasis to improve microcirculation;
• • 12. Allergies to intra arterial injection of contrast agents, blood and blood products;
• • 13. Patients who are participating in other clinical studies.