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|
|Actual Primary Completion Date :||May 2011|
|Actual 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.
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|