Status:
COMPLETED
Mindfulness-Based Stress Reduction and Myocardial Ischemia
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Arteriosclerosis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The principal objective of the study is to evaluate the effectiveness of a widely used complementary medicine intervention, mindfulness-based stress reduction (MBSR), in which mindfulness meditation a...
Detailed Description
BACKGROUND: Acute and chronic psychological stress has been shown to be a risk factor for cardiac events. More recently with the advent of new technology allowing cardiac imaging, acute psychological...
Eligibility Criteria
Inclusion
- At least 18 years old
- Confirmed CAD--the clinical diagnosis of coronary disease will be defined by the presence of at least one of the following: 1) abnormal coronary angiogram; 2) abnormal intravascular ultrasound (IVUS); or 3) abnormal flow reserve and documentation of one of the following: 1) elevated troponin laboratory values typical for myocardial infarction; 2) electrocardiogram (ECG) that shows q-wave abnormalities; 3) nuclear scan that demonstrates a fixed wall motion abnormality consistent with an old myocardial infarct; 4) greater than 95% probability of coronary disease according to the criteria of Diamond and Forrester.102; 5) radionuclide study, dobutamine, or exercise echocardiographic study consistent with stress-induced ischemia (development of segmental wall motion abnormalities or reversible perfusion defects on radionuclide imaging and/or wall motion or systolic thickening abnormalities on stress echocardiographic exam)
Exclusion
- Current pregnancy or probability of pregnancy during the duration of the 12-week study
- Diagnosis of unstable angina in the prior 2 months
- Presence of other severe, complicating medical problems that will significantly shorten the patients' life expectancy such that they will not be expected to live for the 12 weeks of this study
- Presence of serious psychopathology evidenced by BDI scores that indicate a clinically critical level of depression (score of 24 or above) with suicidal ideation; previous diagnosis of an organic mental disorder, schizophrenia, or any psychotic disorder; or psychiatric inpatient at any time during the last 5 years (if patients are excluded on the basis of depression scores indicating severe depression or suicidal ideation, referral for psychological services will be offered)
- Post-traumatic stress disorder (PTSD) greater than the 30% VA disability assignment (patients with less severe PTSD will be encouraged to participate)
- Existing meditation practice
- Weight more than 400 pounds
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00224835
Start Date
May 1 2003
End Date
August 1 2008
Last Update
May 13 2016
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32611