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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)

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ClinicalTrials.gov Identifier: NCT03504202
Recruitment Status : Not yet recruiting
First Posted : April 20, 2018
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Ya-Wei Xu, Shanghai 10th People's Hospital

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.

Condition or disease Intervention/treatment Phase
Patients With INOCA(Ischemia and no Obstructive Coronary Artery Disease) Who Have Coronary Microvascular Dysfunction Drug: Trimetazidine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Trimetazidine on the Improvement of Coronary Microvascular Dysfunction in Patients With INOCA(Ischemia and no Obstructive Coronary Artery Disease)
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Coronary flow reserve (CFR) improves [ Time Frame: six months ]

Secondary Outcome Measures :
  1. Seattle angina score or Canadian angina grade drops [ Time Frame: six months ]
  2. Six-minute walking experiment improves [ Time Frame: six months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Ya-Wei Xu, The chief director of department of cardiology, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT03504202     History of Changes
Other Study ID Numbers: T-MICRO01
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Trimetazidine
Vasodilator Agents