NCT00000471

Brief Summary

To assess long-term effects of a strict lifestyle change program on lipids, blood pressure, myocardial perfusion, and coronary atherosclerosis.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 1989

Typical duration for phase_2 cardiovascular-diseases

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1989

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 1993

Completed
6.7 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

January 1, 2000

First QC Date

October 27, 1999

Last Update Submit

December 12, 2013

Conditions

Cardiovascular DiseasesCoronary ArteriosclerosisCoronary DiseaseHeart DiseasesHypercholesterolemiaHypertensionMyocardial Ischemia

Interventions

diet, vegetarianismBEHAVIORAL
diet, fat-restrictedBEHAVIORAL
exerciseBEHAVIORAL
smoking cessationBEHAVIORAL

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Men and women, ages 35 to 75, with angiographically documented one, two, or three vessel coronary disease; no myocardial infarction during the preceeding six weeks; and not receiving streptokinase, alteplase, or lipid-lowering drugs.

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

Sponsors & Collaborators

Related Publications (3)

  • Ornish D, Brown SE, Scherwitz LW, Billings JH, Armstrong WT, Ports TA, McLanahan SM, Kirkeeide RL, Brand RJ, Gould KL. Can lifestyle changes reverse coronary heart disease? The Lifestyle Heart Trial. Lancet. 1990 Jul 21;336(8708):129-33. doi: 10.1016/0140-6736(90)91656-u.

    PMID: 1973470BACKGROUND

  • Gould KL, Ornish D, Kirkeeide R, Brown S, Stuart Y, Buchi M, Billings J, Armstrong W, Ports T, Scherwitz L. Improved stenosis geometry by quantitative coronary arteriography after vigorous risk factor modification. Am J Cardiol. 1992 Apr 1;69(9):845-53. doi: 10.1016/0002-9149(92)90781-s.

    PMID: 1550011BACKGROUND

  • Gould KL, Ornish D, Scherwitz L, Brown S, Edens RP, Hess MJ, Mullani N, Bolomey L, Dobbs F, Armstrong WT, et al. Changes in myocardial perfusion abnormalities by positron emission tomography after long-term, intense risk factor modification. JAMA. 1995 Sep 20;274(11):894-901. doi: 10.1001/jama.1995.03530110056036.

    PMID: 7674504BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary Artery DiseaseCoronary DiseaseHeart DiseasesHypercholesterolemiaHypertensionMyocardial Ischemia

Interventions

DietDiet, VegetarianDiet, Fat-RestrictedExercise

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDiet, Plant-BasedDiet TherapyNutrition TherapyTherapeuticsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • K. Gould

    University of Texas

  • Dean Ornish

    University of California School of Medicine

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

April 1, 1989

Study Completion

March 1, 1993

Last Updated

December 13, 2013

Record last verified: 2000-01