Effect of Trimetazidine on the Improvement of Coronary Microvascular Dysfunction in Patients With INOCA(Ischemia and no Obstructive Coronary Artery Disease)
T-MICRO
1 other identifier
interventional
10
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2018
CompletedFirst Posted
Study publicly available on registry
April 20, 2018
CompletedStudy Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedOctober 25, 2018
October 1, 2018
1.1 years
April 11, 2018
October 24, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Coronary flow reserve (CFR) improves
six months
Secondary Outcomes (2)
Seattle angina score or Canadian angina grade drops
six months
Six-minute walking experiment improves
six months
Study Arms (1)
Trimetazidine
EXPERIMENTALInterventions
After enrollment, experimental group will receive Trimetazidine(35mg tid) for six months .
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- The chief director of department of cardiology
Study Record Dates
First Submitted
April 11, 2018
First Posted
April 20, 2018
Study Start
March 1, 2019
Primary Completion
April 1, 2020
Study Completion
September 1, 2020
Last Updated
October 25, 2018
Record last verified: 2018-10