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

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

— T-MICRO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03504202
• Other study ID #: T-MICRO01
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: October 2018
• Source: Shanghai 10th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: September 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Trimetazidine
After enrollment, experimental group will receive Trimetazidine(35mg tid) for six months .

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary flow reserve (CFR) improves		six months
Secondary	Seattle angina score or Canadian angina grade drops		six months
Secondary	Six-minute walking experiment improves		six months