T-MICRO: Effect of Trimetazidine on the Improvement of Coronary Microvascular Dysfunction in Patients With INOCA(Ischemia and no Obstructive Coronary Artery Disease)

• Sponsor: Shanghai 10th People's Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03504202
• Collaborator: (none)
• Enrollment: 10
• Arm: 1
• Anticipated Duration (Months): 18.1

Study Details

Study Description

Brief Summary

This is a prospective study which aims to explore the effect of Trimetazidine on the improvement of coronary microvascular dysfunction in patients with INOCA (ischemia and no obstructive coronary artery disease). Enrolled patients will be assessed SAQ(Seattle Angina Score), Canadian Angina Grade(Canadian Cardiovascular Society, CCS), Six-Minute Walk Test, CFR(coronary flow reserve) .CFR inspection with D-SPECT and pressure guide wire.Patients will receive six months Trimetazidine(35mg tid) after enrollment. And their SAQ (Seattle Angina Score), Canadian Angina Grade(Canadian Cardiovascular Society, CCS), Six-Minute Walk Test, CFR will be followed up.

Condition or Disease	Intervention/Treatment	Phase
Patients With INOCA(Ischemia and no Obstructive Coronary Artery Disease) Who Have Coronary Microvascular Dysfunction	Drug: Trimetazidine	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Trimetazidine on the Improvement of Coronary Microvascular Dysfunction in Patients With INOCA(Ischemia and no Obstructive Coronary Artery Disease)
• Anticipated Study Start Date: Mar 1, 2019
• Anticipated Primary Completion Date: Apr 1, 2020
• Anticipated Study Completion Date: Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Trimetazidine	Drug: Trimetazidine; After enrollment, experimental group will receive Trimetazidine(35mg tid) for six months .

Outcome Measures

Primary Outcome Measures

1. Coronary flow reserve (CFR) improves [six months]

Secondary Outcome Measures

1. Seattle angina score or Canadian angina grade drops [six months]

2. Six-minute walking experiment improves [six months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• age≥18 years

• Typical angina symptoms

• Coronary angiography or coronary computed tomography examination showed no significant epicardial coronary artery stenosis (<20%)

• Never used trimetazidine

• The CFR measured by the pressure guide wire is less than 2.0

• agree to participant the study and sign informed written consent

• available for six months follow up

Exclusion Criteria:

• Severe liver and kidney disease

• Contraindications of Trimetazidine

• Use of CYP3A inhibitors, such as diltiazem, verapamil, and other drugs that may affect CFR measurements

• QT interval extension

• Atrial fibrillation or left bundle branch block

• Left ventricular systolic dysfunction (EF <55%)

• Coronary artery fistula

• Myocardial bridge

• Non-cardiogenic chest pain and other heart diseases

• Severe heart valve disease

• Diabetes

• Recent ACS( Acute coronary syndrome)

• Pregnancy

• Failed to complete inspection

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Shanghai 10th People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ya-Wei Xu, The chief director of department of cardiology, Shanghai 10th People's Hospital
• ClinicalTrials.gov Identifier: NCT03504202
• Other Study ID Numbers: T-MICRO01
• First Posted: Apr 20, 2018
• Last Update Posted: Oct 25, 2018
• Last Verified: Oct 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ischemia; Trimetazidine

Study Results

No Results Posted as of Oct 25, 2018