NIPH Clinical Trials Search

Effect of EPA/DHA treatment on coronary hyperintense plaque detected by non-contrast T1-weighted magnetic resonance imaging

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	coronary artery disease with dyslipidemia
Date of first enrollment	2014/12/20
Target sample size	150
Countries of recruitment	Japan
Study type	Interventional,observational
Intervention(s)	2-g group: Subjects will take 2 g per dose of omega-3-acid ethyl esters once daily, immediately after meal. 4-g group: Subjects will take 2 g per dose of omega-3-acid ethyl esters twice daily, immediately after meal. No-treatment group: Subjects will not take omega-3-acid ethyl esters.

Outcome(s)

Primary Outcome

Change in plaque to myocardium ratio (PMR) in the primary lesion measured by non-contrast T1-weighted cardiac magnetic resonance (CMR) imaging (change at study completion or discontinuation from baseline)

Secondary Outcome

1) Change in plaque to myocardium ratio (PMR) in all lesions measured by non-contrast T1-weighted cardiac magnetic resonance (CMR) imaging (change at study completion or discontinuation from baseline) 2) Percent change in plaque to myocardium ratio (PMR) in the primary lesion measured by non-contrast T1-weighted cardiac magnetic resonance (CMR) imaging (percent change at study completion or discontinuation from baseline) 3) Percent change in plaque to myocardium ratio (PMR) in all lesions measured by non-contrast T1-weighted cardiac magnetic resonance (CMR) imaging (percent change at study completion or discontinuation from baseline) 4) Changes in Hounsfield units, plaque volume, vessel area, and plaque area in the primary lesion measured by computed tomography angiography (CTA) (change at study completion or discontinuation from baseline) 5) Changes in Hounsfield units, plaque volume, vessel area, and plaque area in all lesions measured by computed tomography angiography (CTA) (change at study completion or discontinuation from baseline) 6) Percent changes in Hounsfield units, plaque volume, vessel area, and plaque area in the primary lesion measured by computed tomography angiography (CTA) (percent change at study completion or discontinuation from baseline) 7) Percent changes in Hounsfield units, plaque volume, vessel area, and plaque area in all lesions measured by computed tomography angiography (CTA) (percent change at study completion or discontinuation from baseline)

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	Not applicable
Gender	Male and Female
Include criteria
Exclude criteria	1. Use of EPA preparation within 12 weeks before informed consent 2. Scheduled to undergo percutaneous coronary intervention (PCI) or coronary-artery bypass grafting (CABG) during the observation period 3. Presence of type 1 diabetes mellitus or type 2 diabetes mellitus with uncontrolled hyperglycemia (HbA1C more than;8.0%) 4. Presence of bleeding (e.g., hemophilia, capillary fragility, gastrointestinal tract ulcer, urinary tract bleeding, hemoptysis, vitreous hemorrhage) 5. History of hypersensitivity to any component of the investigational product 6. Other patients who are inappropriate for participation in this study in the opinion of the principal investigator or investigator.