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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03504202
Other study ID # T-MICRO01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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