Microvascular Angina Intervention With Compound Danshen Dripping Pill (MAIDS)

Summary

Coronary microvascular disease (MVD) refers to exertional angina or myocardial ischemia caused by abnormal structure and/or function of precoronary arterioles and arterioles under the action of various pathogenic factors. The symptoms of patients with coronary microvascular disease are mainly exertion-related chest pain episodes. The basic and clinical researches of the traditional Chinese medicine compound Danshen dropping pills have found that it can improve vascular endothelial function and relieve angina pectoris, and it is widely used in clinical practice. This is a randomized, double-blind, placebo-controlled, multicenter clinical study of Compound Danshen Dropping Pills and blank control in patients with microvascular angina pectoris. The experimental drug and control drug of this clinical trial were selected according to the ratio of 1:1 patients were enrolled in the pre-experiment. After the selected patients signed the informed consent, they were divided into a compound Danshen dripping pill treatment group and a placebo group according to a random, double-blind, placebo-controlled method. Dosage of Compound Danshen Dropping Pills or placebo: 20 capsules each time, 3 times a day, for a total of 6 months. Follow-up was performed every 2 months for a total of 6 months. Primary study endpoints is the difference of the left anterior descending coronary flow reserve (CFR) measured by ultrasound between the two groups compared with the baseline. Secondary study endpoint include the Number of angina attacks per week, the time of angina pectoris and the time of ischemic ST segment depression in exercise test.

Timeline

Start

2018-12-18

Primary completion

2027-06-30

Completion

2028-06-30

Publications

• Background Mulvagh SL, Rakowski H, Vannan MA, Abdelmoneim SS, Becher H, Bierig SM, Burns PN, Castello R, Coon PD, Hagen ME, Jollis JG, Kimball TR, Kitzman DW, Kronzon I, Labovitz AJ, Lang RM, Mathew J, Moir WS, Nagueh SF, Pearlman AS, Perez JE, Porter TR, Rosenbloom J, Strachan GM, Thanigaraj S, Wei K, Woo A, Yu EH, Zoghbi WA; American Society of Echocardiography. American Society of Echocardiography Consensus Statement on the Clinical Applications of Ultrasonic Contrast Agents in Echocardiography. J Am Soc Echocardiogr. 2008 Nov;21(11):1179-201; quiz 1281. doi: 10.1016/j.echo.2008.09.009.
• Background Porter TR, Abdelmoneim S, Belcik JT, McCulloch ML, Mulvagh SL, Olson JJ, Porcelli C, Tsutsui JM, Wei K. Guidelines for the cardiac sonographer in the performance of contrast echocardiography: a focused update from the American Society of Echocardiography. J Am Soc Echocardiogr. 2014 Aug;27(8):797-810. doi: 10.1016/j.echo.2014.05.011. No abstract available.
• Background Mygind ND, Michelsen MM, Pena A, Frestad D, Dose N, Aziz A, Faber R, Host N, Gustafsson I, Hansen PR, Hansen HS, Bairey Merz CN, Kastrup J, Prescott E. Coronary Microvascular Function and Cardiovascular Risk Factors in Women With Angina Pectoris and No Obstructive Coronary Artery Disease: The iPOWER Study. J Am Heart Assoc. 2016 Mar 15;5(3):e003064. doi: 10.1161/JAHA.115.003064.
• Background Michelsen MM, Pena A, Mygind ND, Frestad D, Gustafsson I, Hansen HS, Kastrup J, Bech J, Host N, Prescott E. Coronary Flow Velocity Reserve Assessed by Transthoracic Doppler: The iPOWER Study: Factors Influencing Feasibility and Quality. J Am Soc Echocardiogr. 2016 Jul;29(7):709-16. doi: 10.1016/j.echo.2016.02.011. Epub 2016 Mar 31.
• Background Prasad M, McBane R, Reriani M, Lerman LO, Lerman A. Coronary endothelial dysfunction is associated with increased risk of venous thromboembolism. Thromb Res. 2016 Mar;139:17-21. doi: 10.1016/j.thromres.2015.12.024. Epub 2015 Dec 29.
• Background Yao GH, Zhang C, Sun FR, Zhang M, Zhao YX, Zhang PF, Zhong L, Ding SF, Chen WQ, Li XN, Zhang Y. Quantification of transmural gradient of blood flow in myocardial ischemia with real-time myocardial contrast echocardiography and dipyridamole stress test. Ultrasound Med Biol. 2008 Jan;34(1):22-30. doi: 10.1016/j.ultrasmedbio.2007.06.019. Epub 2007 Sep 14.

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