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)
Recruitment status was Recruiting
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Purpose
Doctors use magnetic resonance imaging (MRI) to obtain detailed pictures of the inside of the body. This study will evaluate a new MRI technique in people who have recently had a heart attack. Researchers will also examine the effect of fish oil supplementation on heart health in study participants.
| Condition | Intervention | Phase |
|---|---|---|
|
Myocardial Infarction Death, Sudden, Cardiac |
Drug: Omega-3 Fatty Acids (Fish Oil Supplements) Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Prognostic Impact and Arrhythmic Potential of Peri-Infarct Zone by Cardiac MRI |
- Predictive value of peri-infarct zone on sudden cardiac death [ Time Frame: Measured in the 3-year follow-up period after participant's last study visit ] [ Designated as safety issue: No ]
- Effect of omega-3 fatty acids on sudden cardiac death after a heart attack [ Time Frame: Measured in the 3-year follow-up period after participant's last study visit ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 414 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Participants will receive a highly purified form of omega-3 fatty acids for 9 months.
|
Drug: Omega-3 Fatty Acids (Fish Oil Supplements)
4 grams of omega-3 fatty acids taken orally once per day for 9 months
Other Name: Lovaza (GlaxoSmithKline)
|
|
Placebo Comparator: 2
Participants will receive placebo for 9 months.
|
Drug: Placebo
Placebo tablets taken orally once per day for 9 months
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Raymond Y. Kwong, MD, MPH, FACC | 857-307-1960 | rykwong@partners.org |
| Contact: Mahadevan Rajaram, MD, FRCPC | 857-307-1960 | mrajaram@partners.org |
| United States, Massachusetts | |
| Brigham and Women's Hospital, Shapiro Cardiovascular Center | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Raymond Y. Kwong, MD, MPH, FACC 857-307-1960 rykwong@partners.org | |
| Contact: Mahadevan Rajaram, MD, FRCPC 857-307-1960 mrajaram@partners.org | |
| Principal Investigator: Raymond Y. Kwong, MD, MPH, FACC | |
| Sub-Investigator: Mahadevan Rajaram, MD, FRCPC | |
| Sub-Investigator: Shuaib M. Abdullah, MD | |
| Principal Investigator: | Raymond Y. Kwong, MD, MPH, FACC | Brigham and Women's Hospital |
More Information
Publications:
| Responsible Party: | Raymond Y. Kwong, MD, MPH, FACC, Director-Cardiac MRI, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT00729430 History of Changes |
| Other Study ID Numbers: | 591, 1 R01 HL091157-01A1 |
| Study First Received: | August 4, 2008 |
| Last Updated: | February 20, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
|
Heart Attack Sudden Cardiac Death Peri-infarct Zone Omega-3 Fatty Acids |
Biological Markers Cytogenetic Analysis Cardiac Arrest |
Additional relevant MeSH terms:
|
Death, Sudden, Cardiac Heart Diseases Cardiovascular Diseases Heart Arrest Death Death, Sudden Infarction |
Myocardial Infarction Pathologic Processes Ischemia Necrosis Myocardial Ischemia Vascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013