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

This study has been completed.

First Received: October 21, 2005 Last Updated: October 28, 2005 History of Changes

Sponsored by:	SwedishAmerican Health System
Information provided by:	SwedishAmerican Health System
ClinicalTrials.gov Identifier:	NCT00243581

Purpose

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.

Condition	Intervention	Phase
a Myocardial Infarction Coronary Artery Bypass Graft Surgery Percutaneous Transluminal Coronary Angioplasty Stent Placement	Behavioral: Dean Ornish Heart Disease Reversing Program	Phase IV

MedlinePlus related topics: Heart Attack Heart Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Placebo Control, Single Group Assignment
Official Title:	The Effects of an Intensive Lifestyle Modification Program on Carotid Artery Intima-Media Thickness

Further study details as provided by SwedishAmerican Health System:

Study Start Date:	August 2000
Estimated Study Completion Date:	May 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00243581

Sponsors and Collaborators

SwedishAmerican Health System

Investigators

Principal Investigator:

Steven G. Aldana, Ph.D.

SwedishAmerican Health System

More Information

No publications provided

Study ID Numbers:	SACCM Ornish Clinical Trial
Study First Received:	October 21, 2005
Last Updated:	October 28, 2005
ClinicalTrials.gov Identifier:	NCT00243581 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Necrosis
Heart Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases

Cardiovascular Diseases
Ischemia
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on May 07, 2009