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

Primary Purpose

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

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Trimetazidine

About this trial

This is an interventional treatment trial for Patients With INOCA(Ischemia and no Obstructive Coronary Artery Disease) Who Have Coronary Microvascular Dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Trimetazidine

Arm Description

Outcomes

Primary Outcome Measures

Coronary flow reserve (CFR) improves

Secondary Outcome Measures

Seattle angina score or Canadian angina grade drops

Six-minute walking experiment improves

Full Information

NCT ID

NCT03504202

First Posted

April 11, 2018

Last Updated

October 24, 2018

Sponsor

Shanghai 10th People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03504202

Brief Title

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

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2019 (Anticipated)

Primary Completion Date

April 1, 2020 (Anticipated)

Study Completion Date

September 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai 10th People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Trimetazidine

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Trimetazidine

Intervention Description

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

Primary Outcome Measure Information:

Title

Coronary flow reserve (CFR) improves

Time Frame

six months

Secondary Outcome Measure Information:

Title

Seattle angina score or Canadian angina grade drops

Time Frame

six months

Title

Six-minute walking experiment improves

Time Frame

six months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Learn more about this trial

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

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