NCT00000508

Brief Summary

To determine whether modification of risk factors altered the rate of progression of coronary artery disease in arteries with mild atherosclerosis and no mechanical intervention in patients who had coronary bypass surgery or 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 Sep 1983

Longer than P75 for phase_3 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

September 1, 1983

Completed
9.5 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

January 12, 2016

Status Verified

March 1, 1993

First QC Date

October 27, 1999

Last Update Submit

January 8, 2016

Conditions

Cardiovascular DiseasesCoronary ArteriosclerosisCoronary DiseaseHeart DiseasesMyocardial Ischemia

Interventions

smoking cessationBEHAVIORAL
diet, reducingBEHAVIORAL
exerciseBEHAVIORAL
diet, fat-restrictedBEHAVIORAL

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Men and women, up to 75 years of age. Patients with coronary artery disease but no mechanical intervention on all major vessels.

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

Sponsors & Collaborators

Related Publications (6)

  • Leung WH, Demopulos PA, Alderman EL, Sanders W, Stadius ML. Evaluation of catheters and metallic catheter markers as calibration standard for measurement of coronary dimension. Cathet Cardiovasc Diagn. 1990 Nov;21(3):148-53. doi: 10.1002/ccd.1810210305.

    PMID: 2225049BACKGROUND

  • Burge C, Sanders W, Alderman EL. Anatomic and machine projection angles of various radiographic imaging systems used for cardiac angiography. Cathet Cardiovasc Diagn. 1991 Jan;22(1):64-74. doi: 10.1002/ccd.1810220116.

    PMID: 1995179BACKGROUND

  • Maron DJ, Fair JM, Haskell WL. Saturated fat intake and insulin resistance in men with coronary artery disease. The Stanford Coronary Risk Intervention Project Investigators and Staff. Circulation. 1991 Nov;84(5):2020-7. doi: 10.1161/01.cir.84.5.2020.

    PMID: 1934376BACKGROUND

  • Haskell WL, Alderman EL, Fair JM, Maron DJ, Mackey SF, Superko HR, Williams PT, Johnstone IM, Champagne MA, Krauss RM, et al. Effects of intensive multiple risk factor reduction on coronary atherosclerosis and clinical cardiac events in men and women with coronary artery disease. The Stanford Coronary Risk Intervention Project (SCRIP). Circulation. 1994 Mar;89(3):975-90. doi: 10.1161/01.cir.89.3.975.

    PMID: 8124838BACKGROUND

  • Quinn TG, Alderman EL, McMillan A, Haskell W. Development of new coronary atherosclerotic lesions during a 4-year multifactor risk reduction program: the Stanford Coronary Risk Intervention Project (SCRIP). J Am Coll Cardiol. 1994 Oct;24(4):900-8. doi: 10.1016/0735-1097(94)90848-6.

    PMID: 7930223BACKGROUND

  • Miller BD, Alderman EL, Haskell WL, Fair JM, Krauss RM. Predominance of dense low-density lipoprotein particles predicts angiographic benefit of therapy in the Stanford Coronary Risk Intervention Project. Circulation. 1996 Nov 1;94(9):2146-53. doi: 10.1161/01.cir.94.9.2146.

    PMID: 8901665BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary Artery DiseaseCoronary DiseaseHeart DiseasesMyocardial Ischemia

Interventions

Diet, ReducingExerciseDiet, Fat-Restricted

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Edwin Alderman

    Stanford University

  • Ronald Krauss

    University of California

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
PREVENTION
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

September 1, 1983

Study Completion

March 1, 1993

Last Updated

January 12, 2016

Record last verified: 1993-03