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

Tongji University

Status: Unknown

Conditions: Patients With INOCA(Ischemia and no Obstructive Coronary Artery Disease) Who Have Coronary Microvascular Dysfunction

Treatments: Drug: Trimetazidine

Study type: Interventional

Funder types: Other

Identifiers

NCT03504202

T-MICRO01

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Trimetazidine

Experimental group

Treatment:

Drug: Trimetazidine