Prognostic, Anti-arrhythmic, and Ventricular Remodeling Effects of High Dose Fish Oil in Patients With a Recent Myocardial Infarction
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 358
- 试验地点
- 1
- 主要终点
- Effect of Omega-3 Fatty Acids on Adverse Left Ventricular Remodeling
研究概览
简要总结
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.
详细描述
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.
Apart from studying the likelihood of sudden cardiac death, This study will measure the change in structure and pumping function of the heart (known as ventricular remodeling) and this study will determine if the high dose of fish oil treatment will result in an improvement of the heart.
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 6 months. Every 2 to 3 months, study researchers will call participants to check on their health and progress. At a study visit at Month 6, 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
- •Hemodynamic instability
- •Urgent clinical need for a pacemaker or AICD
- •Inaccessibility of medical records
研究组 & 干预措施
Omega-3 Fatty Acids
Participants will receive a highly purified form of omega-3 fatty acids for 6 months.
干预措施: Omega-3 Fatty Acids (Fish Oil Supplements) (Drug)
Placebo
Participants will receive placebo for 6 months.
干预措施: Placebo (Drug)
结局指标
主要结局
Effect of Omega-3 Fatty Acids on Adverse Left Ventricular Remodeling
时间窗: Before and after study treatments
Measured as change in left ventricular end-systolic volume indexed to body surface area from baseline to post-treatment (6-months)
次要结局
- Effect of Omega-3 Fatty Acids on Non-Infarct Myocardial Fibrosis(Measured in the 3-year follow-up period after participant's last study visit)
- Effect of Omega-3 Fatty Acids on Infarct Size(Measured in the 3-year follow-up period after participant's last study visit)
- Effect of Omega-3 Fatty Acids on Left Ventricular Ejection Fraction(Measured in the 3-year follow-up period after participant's last study visit)
研究者
Raymond Y. Kwong, MD
Principal Investigator
Brigham and Women's Hospital
