The Effects of an Intensive Lifestyle Modification Program on Carotid Artery Intima-Media Thickness

NCT ID: NCT00243581

Last Updated: 2005-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2000-08-31

Study Completion Date

2005-05-31

Brief Summary

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The objective of this study is to evaluate the effect of the Ornish Program on cardiovascular disease as measured by the IMT of the common carotid artery, and to compare this effect to outcomes from patients participating in traditional cardiac rehabilitation.

Detailed Description

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Conditions

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a Myocardial Infarction Coronary Artery Bypass Graft Surgery Percutaneous Transluminal Coronary Angioplasty Stent Placement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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Dean Ornish Heart Disease Reversing Program

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Patients will be accepted into the study if they demonstrate one or more of the following within the previous 12 months: a myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty, stent placement, or rotoblator procedures. Patients will also accepted if they have stable angina as determined by the Rose Questionnaire or pacemaker associated with one or more of the previously mentioned diagnoses. For the purposes of this study, myocardial infarction is defined as the presence of at least two of the following three criteria: continuous chest pain lasting at least 30 minutes; electrocardiogram changes expressing an evolving myocardial infarction (ST segment elevation or depression, evolving Q waves, or symmetric inversion of T waves); or elevated cardiac enzyme levels (at least twice the I levels).

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SwedishAmerican Health System

OTHER

Sponsor Role lead

Principal Investigators

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Steven G. Aldana, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

SwedishAmerican Health System

Other Identifiers

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SACCM Ornish Clinical Trial

Identifier Type: -

Identifier Source: org_study_id