The Effects of Lovaza® in Acute Myocardial Infarction (OmegaMI)
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|ClinicalTrials.gov Identifier: NCT01155336|
Recruitment Status : Terminated (Only 5 individuals were able to be recruited.)
First Posted : July 1, 2010
Results First Posted : March 11, 2013
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Infarction||Drug: Lovaza® Drug: The placebo contained 1 gram of corn oil in each capsule.||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effects of Lovaza® on Platelet Function and Cardiac Electrophysiology in Acute Myocardial Infarction|
|Study Start Date :||June 2010|
|Primary Completion Date :||May 2011|
|Study Completion Date :||May 2011|
Lovaza® is a prescription grade EPA+DHA fish oil supplement. Four capsules (each containing 1 gram of fish oil) were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.
Lovaza® is prescription grade EPA+DHA fish oil supplement.
Other Name: Fish oil
Placebo Comparator: Corn Oil
The placebo contained 1 gram of corn oil in each capsule. Four capsules were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.
Drug: The placebo contained 1 gram of corn oil in each capsule.
Other Name: Corn oil
- Platelet Function [ Time Frame: 12 hours ]Platelet function will be measured with PFA-100 test which has been shown to correlate with an increased risk for cardiovascular events in several well conducted studies and in a meta-analysis. The PFA-100 measures the number of seconds required for a clot to form in whole blood which is passed through an aperture in a cartridge coated with epinephrine. It is meant to imitate clotting in human arteries.
- Cardiac Electrophysiology [ Time Frame: 1 week ]A 20-minute supine 12-lead Holter ECG will allow the quantification of a series of standard ECG parameters as well as provide insight into frequency-domain HRV parameters, QRS duration and morphology, using signal-averaged ECG (SAECG), repolarization morphology, and variability utilizing specialized programs.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155336
|United States, New York|
|University or Rochester|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Robert Block, MD, MPH||University or Rochester|