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NCT01624727 · ClinicalTrials.gov registry record · NA
Slowing HEART diSease With Lifestyle and Omega-3 Fatty Acids
A NA study of Metabolic Syndrome and Coronary Heart Disease, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 338
- Enrollment target
- 2
- Study locations
NCT01624727: Completed NA study of Metabolic Syndrome and Coronary Heart Disease, sponsored by Beth Israel Deaconess Medical Center.
NCT01624727 is a NA study of Metabolic Syndrome and Coronary Heart Disease that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 338 participants, below the 1,202-participant average among 102 other Metabolic Syndrome trials with a reported enrollment target (72% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01624727, a NA study of Metabolic Syndrome and Coronary Heart Disease, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 338 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of the study is to target inflammation to reduce progression of noncalcified plaque in the coronary arteries using omega-3 fatty acid supplementation compared to standard of care.
Primary Outcome
MDCTA is performed at baseline to quantitate the amount of noncalcified and calcified coronary plaque and again at 30 month follow-up to determine if there has been a change in the volume of noncalcified or total plaque. The primary endpoint is change in coronary noncalcified plaque volume during the 30 months of intervention between active and standard of care. The hypothesis is that those on Lovaza will have less progression of coronary plaque compared to those in usual care.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Omega 3 acid ethyl esters
Study Locations (2)
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
- South Shore Medical Group - Milton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 338 participants |
| Start Date | 2009-06 |
| Est. Completion | 2015-01-15 |
| Phase | NA |
What the finished NCT01624727 record still lists
NCT01624727 is an interventional study that assigns participants to a tested intervention. The registered 338 participants enrollment target is mid-sized for trials with a published cap, below the 1,202-participant average among 102 other Metabolic Syndrome trials with a reported enrollment target (72% lower).
The record links to 2 conditions, with Metabolic Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Omega 3 acid ethyl esters is the first listed.
NCT01624727 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01624727 about?
NCT01624727 is a clinical study titled "Slowing HEART diSease With Lifestyle and Omega-3 Fatty Acids". The purpose of the study is to target inflammation to reduce progression of noncalcified plaque in the coronary arteries using omega-3 fatty acid supplementation compared to standard of care.
What is the current status of trial NCT01624727?
This trial is currently completed. It is a NA study. The enrollment target is 338 participants. The study started on 2009-06. Estimated completion is 2015-01-15.
What conditions does trial NCT01624727 study?
This clinical trial studies the following conditions: Metabolic Syndrome, Coronary Heart Disease.
What interventions are being tested in trial NCT01624727?
The interventions under investigation include: Omega 3 acid ethyl esters (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01624727?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01624727 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01624727's enrollment target sits among peer trials
338 16th of 102 higher than 87 of 102 other Metabolic Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metabolic Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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