Microvascular Angina Intervention With Compound Danshen Dripping Pill (MAIDS)

NCT06092736 | Recruiting Phase 4 DMC

• 1 other identifier: 11671808
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Microvascular Angina

Keywords

Coronary Blood Flow Reserve; Microvascular Angina; Compound Danshen Dripping Pill; echocardiography

Outcome Measures

Primary Outcomes (1)

• The change of the left anterior descending coronary flow reserve (CFR)measured by echocardiography.

  the difference of the left anterior descending coronary flow reserve (CFR) measured by ultrasound between the two groups.

  At the end of 6-month follow-up compared to the baseline

Secondary Outcomes (3)

• Number of angina attacks per week.

  During 6 months of following up.

• The time of angina pectoris in exercise test.

  At the end of 6-month follow-up compared to the baseline.

• The time of ischemic ST segment depression in exercise test.

  At the end of 6-month follow-up compared to the baseline.

Study Arms (2)

Compound Danshen Dropping Pills

EXPERIMENTAL

Treatment group: Compound Danshen Dropping Pills (Tianjin Tasly Co., Ltd.), orally after meals, 3 times a day, 20 capsules each time.

Drug: Compound Danshen Dropping Pills

Placebo

PLACEBO COMPARATOR

Placebo group: placebo (appearance is the same as Compound Danshen Dropping Pills, main ingredient: starch. Production unit: Tianjin Tasly Co., Ltd.), orally after meals, 3 times a day , 20 capsules each time.

Drug: Placebo

Interventions

Compound Danshen Dropping Pills DRUG

Dosage of Compound Danshen Dropping Pills: 20 capsules each time, 3 times a day, after meals. The follow-up period was 6 months.

Compound Danshen Dropping Pills

Placebo DRUG

placebo (appearance is the same as Compound Danshen Dropping Pills, main ingredient: starch. Production unit: Tianjin Tasly Co., Ltd.), orally after meals, 3 times a day , 20 capsules each time.

Placebo

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• with typical symptoms of exertional angina;
• coronary CTA or angiography with normal coronary artery or \<50% stenosis, or \<50% residual coronary stenosis after revascularization;
• 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);
• Transthoracic ultrasound examination of blood in the anterior descending coronary artery before and after intravenous injection of adenosine Flow reserve check CFR\<2.5;
• The patient himself agrees to participate in this study.

You may not qualify if:

• Less than 30 years old or more than 75 years old;
• Have a history of carotid endarterectomy or stent implantation, and have a history of stroke;
• Myocarditis, pericardial disease, valvular disease, cardiomyopathy;
• Difficult to control diabetes mellitus (fasting blood glucose\>7.0 mmol/L);
• Uncontrolled hypertension (SBP\>150 mmHg and/or DBP\>90 mmHg);
• Familial hypercholesterolemia;
• Multiple Takayasu arteritis;
• Those who are pregnant or lactating, or have fertility intention within one year, or have not taken effective contraceptive measures during the childbearing period;
• 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);
• Other respiratory, digestive, blood, infection, immunity, endocrine, neuropsychiatric, tumor diseases with clinical significance that may cause serious danger to patients;
• Taking traditional Chinese medicine preparations of K channel opener, promoting blood circulation and removing blood stasis to improve microcirculation;
• Allergies to intra arterial injection of contrast agents, blood and blood products;
• Patients who are participating in other clinical studies.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 18992671 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.

  PMID: 25085408 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.

  PMID: 27068634 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.

  PMID: 27038514 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.

  PMID: 26916291 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.

  PMID: 17854984 BACKGROUND

MeSH Terms

Conditions

Microvascular Angina

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Yun Zhang, PhD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun Zhang, PhD

CONTACT

+86-18560086626; zhangyun@sdu.edu.cn

Xiaoling Liu, PhD

CONTACT

+86-18560086718; xiaolingliusdu@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2023
• First Posted: October 23, 2023
• Study Start: December 18, 2018
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: October 23, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The sharing time period is 6 months to 1 year after the data is released.
• Access Criteria: Share IPD under the conditions of protecting the privacy of patients and ensuring the safety of all diseases. It is necessary to contact the researcher and open the sharing authority after the researcher's consent.

Locations

CN (1)