NCT00000473

Brief Summary

To determine whether a dietary supplement of n-3 polyunsaturated fatty acids (PUFAs) derived from fish oil would decrease the restenosis rate in patients undergoing percutaneous transluminal coronary angioplasty (PTCA).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jul 1989

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1989

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 1994

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

December 13, 2013

Status Verified

April 1, 2012

First QC Date

October 27, 1999

Last Update Submit

December 12, 2013

Conditions

Cardiovascular DiseasesCoronary DiseaseHeart DiseasesMyocardial Ischemia

Interventions

dietary supplementsBEHAVIORAL
fatty acids, omega-3DRUG
diet, fat-restrictedBEHAVIORAL

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Men and women with coronary heart disease in the native coronary arteries. Patients were symptomatic or had 50 percent or greater stenosis as defined by coronary angiography. Patients had not undergone prior angioplasty.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (2)

  • Leaf A, Jorgensen MB, Jacobs AK, Cote G, Schoenfeld DA, Scheer J, Weiner BH, Slack JD, Kellett MA, Raizner AE, et al. Do fish oils prevent restenosis after coronary angioplasty? Circulation. 1994 Nov;90(5):2248-57. doi: 10.1161/01.cir.90.5.2248.

    PMID: 7955181BACKGROUND

  • Timaran CH, Mantese VA, Malas M, Brown OW, Lal BK, Moore WS, Voeks JH, Brott TG; CREST Investigators. Differential outcomes of carotid stenting and endarterectomy performed exclusively by vascular surgeons in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST). J Vasc Surg. 2013 Feb;57(2):303-8. doi: 10.1016/j.jvs.2012.09.014. Epub 2012 Dec 20.

    PMID: 23265585DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary DiseaseHeart DiseasesMyocardial Ischemia

Interventions

Dietary SupplementsFatty Acids, Omega-3Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesDietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological Phenomena

Study Officials

  • Alexander Leaf

    Massachusetts General Hospital

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

July 1, 1989

Study Completion

June 1, 1994

Last Updated

December 13, 2013

Record last verified: 2012-04