Evaluating a Heart Magnetic Resonance Imaging (MRI) Procedure and the Effect of Fish Oil Supplementation in People Who Have Recently Had a Heart Attack (The PROSPECT-CMR Study)

A new MRI technique to examine the heart was recently developed. In this study, researchers
will use this new technique to evaluate the heart in people who have recently had a heart
attack to determine whether a specific pattern of heart muscle damage is related to sudden
cardiac death. This fatal condition, also known as cardiac arrest, occurs when the heart
abruptly stops pumping blood to the body, resulting in loss of consciousness, absence of
pulse, and a stop in breathing. The most common cause of sudden cardiac death is a heart
attack.

In addition to evaluating the new heart MRI technique, this study will also examine the
effects of fish oil supplementation in people who have recently had a heart attack. Recent
research has shown that omega-3 fatty acids, commonly found in fish oil, may be beneficial
for people with heart conditions. Lastly, the study will determine whether specific
biomarkers and genetic factors can help predict the likelihood of a person dying from sudden
cardiac death after previously experiencing a heart attack.

This study will enroll people who have had a heart attack in the 2 to 4 weeks before study
entry. At a baseline study visit, participants will undergo an MRI of their heart and
complete an exercise stress test on a treadmill. A blood sample will be collected, and women
will provide a urine sample for a pregnancy test. Questionnaires asking about diet, medical
history, and emotions will also be completed. Participants will then be randomly assigned to
receive either fish oil supplements or placebo on a daily basis for 9 months. Every 2 to 3
months, study researchers will call participants to check on their health and progress. At a
study visit at Month 9, participants will undergo repeat baseline testing. After this visit,
study researchers will call participants every 6 months for 3 years to follow up on
participants' health status.

Inclusion Criteria:

- Experienced a heart attack in the 2 to 4 weeks before study entry

- Lives in the greater Boston area or adjacent regions (within a 50-mile radius of
Boston)

Exclusion Criteria:

- Unable to undergo an MRI because of metallic implants (e.g., pacemakers, an
implantable cardioverter defibrillator [AICD]) at time of study entry

- Active cancer or any other terminal illness with an expected survival rate of less
than 6 months after study entry

- Significant kidney dysfunction with a glomerular filtration rate (GFR) of less than
60 mL/min in the 2 weeks before study entry

- Inability to follow study procedures

- Pregnant

- Hemodynamic instability

- Urgent clinical need for a pacemaker or AICD

- Inaccessibility of medical records