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Coronary Artery Disease with Excess Weight

TINSAL Trial

Targeting Inflammation Using Salsalate or Lifestyle Intervention in Cardiovascular Disease

Principal investigator

Francine Welty, MD, PhD

Co-investigators

Melvin Clouse, MD
Ernst Schaefer, MD
Allison Goldfine, MD
Steve Shoelson, MD, PhD
Thomas Hauser, MD

Coordinator

Jennifer Vetter
Phone: 617-632-7656
Email: TINSAL@bidmc.harvard.edu

Focus: Patients with coronary heart disease who are at least mildly overweight

The goal is to learn more about controlling inflammation, a process that contributes to development of dangerous soft plaque in the arteries supplying the heart. The presence of soft plaque is sometimes called "silent heart disease" because it is difficult to detect. A new cardiac Computer Tomography (CT) scanner detects soft plaque non-invasively.

The study will measure the impact of three factors on inflammation: lifestyle (diet, exercise, weight loss and an Omega-3 fatty acid supplement (fish oil capsules); salsalate (an anti-inflammatory drug which is approved to treat arthritis); and a placebo. The study may help develop a better treatment for people who have heart disease and are at least mildly overweight.

Study subjects will have the new CT scan which can look inside the blood vessels of the heart non-invasively. At the end of the study, they'll have a repeat CT scan to see if their blockages are improved, the same or worse.

The study offers two additional options. One is a dental exam to see if the health of the teeth and gums contributes to the plaque build-up in our arteries and whether the type of bacteria in the mouth might prevent a person from losing weight. The second is a magnetic resonance imaging (MRI) study of the aorta, the large vessel from the heart to all parts of the body to see if there is plaque build-up.

Financial compensation is provided.