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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00243581
Other study ID # SACCM Ornish Clinical Trial
Secondary ID
Status Completed
Phase Phase 4
First received October 21, 2005
Last updated October 28, 2005
Start date August 2000
Est. completion date May 2005

Study information

Verified date May 2005
Source SwedishAmerican Health System
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date May 2005
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility 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:

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Dean Ornish Heart Disease Reversing Program


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
SwedishAmerican Health System