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

This study has been completed.
Sponsor:
Information provided by:
SwedishAmerican Health System
ClinicalTrials.gov Identifier:
NCT00243581
First received: October 21, 2005
Last updated: October 28, 2005
Last verified: May 2005
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: The Effects of an Intensive Lifestyle Modification Program on Carotid Artery Intima-Media Thickness

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014