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

Not Applicable

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

• Registration Number: NCT03504202
• Lead Sponsor: Shanghai 10th People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-11
• Study First Submitted QC: 2018-04-19
• Study First Posted: 2018-04-20
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-24
• Last Update Posted: 2018-10-25
• Study Start: 2019-03-01
• Primary Completion: 2020-04-01
• Study Completion: 2020-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Trimetazidine	Trimetazidine	-

Primary Outcome Measures

Name	Time	Method
Coronary flow reserve (CFR) improves	six months

Secondary Outcome Measures

Name	Time	Method
Six-minute walking experiment improves	six months
Seattle angina score or Canadian angina grade drops	six months