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

October 24, 2018 updated by: Ya-Wei Xu, Shanghai 10th People's Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trimetazidine
Drug: Trimetazidine
After enrollment, experimental group will receive Trimetazidine(35mg tid) for six months .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Coronary flow reserve (CFR) improves
Time Frame: six months
six months

Secondary Outcome Measures

Outcome Measure
Time Frame
Seattle angina score or Canadian angina grade drops
Time Frame: six months
six months
Six-minute walking experiment improves
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 10th People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2019

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

April 11, 2018

First Submitted That Met QC Criteria

April 19, 2018

First Posted (Actual)

April 20, 2018

Study Record Updates

Last Update Posted (Actual)

October 25, 2018

Last Update Submitted That Met QC Criteria

October 24, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T-MICRO01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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

Clinical Trials on Trimetazidine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe