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)

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Information provided by (Responsible Party):
Raymond Y. Kwong, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00729430
First received: August 4, 2008
Last updated: July 30, 2013
Last verified: July 2013

August 4, 2008
July 30, 2013
August 2008
May 2013   (final data collection date for primary outcome measure)
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 ]
Predictive value of Peri-infarct zone on Sudden Cardiac Death [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00729430 on ClinicalTrials.gov Archive Site
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 ]
Effect of Omega-3 fatty acids on Sudden Cardiac Death post STEMI [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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)
Prognostic Impact and Arrhythmic Potential of Peri-infarct Zone by Cardiac MRI

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Myocardial Infarction
  • Death, Sudden, Cardiac
  • 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)
  • Drug: Placebo
    Placebo tablets taken orally once per day for 9 months
  • Experimental: 1
    Participants will receive a highly purified form of omega-3 fatty acids for 9 months.
    Intervention: Drug: Omega-3 Fatty Acids (Fish Oil Supplements)
  • Placebo Comparator: 2
    Participants will receive placebo for 9 months.
    Intervention: Drug: Placebo
Yan AT, Shayne AJ, Brown KA, Gupta SN, Chan CW, Luu TM, Di Carli MF, Reynolds HG, Stevenson WG, Kwong RY. Characterization of the peri-infarct zone by contrast-enhanced cardiac magnetic resonance imaging is a powerful predictor of post-myocardial infarction mortality. Circulation. 2006 Jul 4;114(1):32-9. Epub 2006 Jun 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
374
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00729430
591, R01HL091157-01, 1 R01 HL091157-01A1
Yes
Raymond Y. Kwong, MD, Brigham and Women's Hospital
Brigham and Women's Hospital
  • National Heart, Lung, and Blood Institute (NHLBI)
  • GlaxoSmithKline
Principal Investigator: Raymond Y. Kwong, MD, MPH, FACC Brigham and Women's Hospital
Brigham and Women's Hospital
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP