Slowing HEART diSease With Lifestyle and Omega-3 Fatty Acids

Completed · Not applicable

Conditions studied: Coronary Heart Disease, Metabolic Syndrome

In brief

The purpose of the study is to target inflammation to reduce progression of noncalcified plaque in the coronary arteries using omega-3 fatty acid supplementation compared to standard of care.

Key facts

Study ID

NCT01624727

Run by

Beth Israel Deaconess Medical Center

People needed

338

Starts

2009-06-01

Expected to finish

2015-01-15

Last updated by the study team

2017-09-27

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• coronary artery disease
• previous myocardial infarction
• angioplasty (> 6 months ago)
• previous coronary bypass surgery (> 12 months ago)
• stable angina
• non-calcified plaque on prior CT
• abnormal exercise tolerance test
• aged 21- 80 years
• BMI ≥ 27 kg/m2 and ≤ 35 kg/m2 if female and ≤ 40 kg/m2 if male (a BMI > 24.5 for subjects from Asian origin)
• stable dose of statin for 1 month at screening or unable to tolerate a statin
• normal renal function - estimated creatinine clearance calculated using Cockcroft-Gault (CG) equation ≥60 at screening [eCrCLCG (ml/min) = [(140 - age) x weight (kg)]/[SCr(mg/dl) x 72] x [0.85 if female] or serum Cr < 1.3
• ALT, AST) < 3 times upper limits of normal)
• normal thyroid function or on stable dose replacement therapy
• an ETT performed within 12 months prior

You may not qualify if…

• unstable angina (increase in frequency or severity of anginal episodes or development of chest pain at rest)
• significant obstructive disease in left main coronary artery, ostial LAD or newly diagnosed three-vessel disease since prior cardiac catheterization by MDCTA
• significant heart failure (NYHA class III and IV)
• Current atrial fibrillation or Wolf-Parkinson-White (WPW) syndrome
• allergy to beta-blocker in subjects with resting heart rate > 65 bpm
• systolic blood pressure > 160 mm Hg
• diastolic BP > 100 mm Hg
• persons with allergies to iodinated contrast material or shellfish
• allergy to nitroglycerin
• history of asthma only if unable to tolerate beta-blockers
• BMI > 35 kg/m2 if female and > 40 kg/m2 if male
• body weight > 350 lbs
• Use of drugs for weight loss [eg Xenical (orlistat), Meridia (sibutramine), Acutrim (phenylpropanolamine) or similar over-the-counter medications] within three months of screening
• surgery within 30 days of screening
• history of acquired immune deficiency syndrome or human immunodeficiency virus (HIV)
• poor mental function or history of dementia/Alzheimer's Disease or on medications used for treatment of dementia [e.g. Tacrine (Cognex), Rivastigmine (Exelon), Galantamine (Razadyne, Reminyl), Donepezil (Aricept), Memantine (Namenda)] or any other reason to except patient difficulty in complying with the requirements of the study
• medicine for erectile dysfunction within 72 hours prior to MDCTA
• Prior stroke with residual cognitive deficit or functional deficit preventing any type of exercise
• Current chemotherapy or radiation for malignancy
• Current weekly alcohol consumption > 21 units/week (1 unit = 1 beer, 1 glass of wine, 1 mixed cocktail containing 1 ounce of alcohol)
• Exclusions based on nuclear imaging:
• Transient cavity dilation
• More than one vascular territory involved with reversible defect (multiple defects)
• Reversible defects involving the anterior wall, septum or apex (LAD territory)
• Exclusions based on echocardiography imaging:

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• South Shore Medical Group — Milton, Massachusetts, United States

Full record on ClinicalTrials.gov

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