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
  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
Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 374
Study Start Date: August 2008
Study Completion Date: May 2013
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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729430

Locations
United States, Massachusetts
Brigham and Women's Hospital, Shapiro Cardiovascular Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
GlaxoSmithKline
Investigators
Principal Investigator: Raymond Y. Kwong, MD, MPH, FACC Brigham and Women's Hospital
  More Information

Publications:
Responsible Party: Raymond Y. Kwong, MD, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00729430     History of Changes
Other Study ID Numbers: 591, R01HL091157-01, 1 R01 HL091157-01A1
Study First Received: August 4, 2008
Last Updated: July 30, 2013
Health Authority: United States: Federal Government

Keywords provided by Brigham and Women's Hospital:
Heart Attack
Sudden Cardiac Death
Peri-infarct Zone
Omega-3 Fatty Acids
Biological Markers
Cytogenetic Analysis
Cardiac Arrest

Additional relevant MeSH terms:
Death, Sudden
Death, Sudden, Cardiac
Infarction
Myocardial Infarction
Cardiovascular Diseases
Death
Heart Arrest
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014