Stress Reduction to Reduce Risk for Arrhythmia in ICD Patients (The RISTA Study)
Completed · Not applicable
Conditions studied: Arrhythmias, Cardiac
In brief
An implantable cardioverter defibrillator (ICD) is a small device that is implanted in the chest and uses electrical shocks to control arrhythmias, which are abnormal heart rhythms. Arrhythmias can be caused by many factors, including stress and anger. This study will evaluate the use of a stress reduction treatment (SRT) program aimed at reducing the occurrence of arrhythmias that require treatment with an ICD shock.
Key facts
- Study ID
- NCT00627263
- Run by
- Yale University
- People needed
- 314
- Starts
- 2008-01-01
- Expected to finish
- 2012-12-01
- Last updated by the study team
- 2018-01-17
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Receiving an ICD or currently have an ICD and have recieved appropriated ICD shock therapy in the 6 months before study entry
- Ischemic cardiomyopathy or non-ischemic (dilated) cardiomyopathy
- Fluent in spoken and written English
- Able to participate in the SRT program
You may not qualify if…
- Unable to comply with the study or participate in SRT treatment, if assigned
- Incapacitating illness (e.g., stage IV congestive heart failure) that would interfere with study participation
- Life expectancy of less than 2 years (e.g., due to metastatic cancer)
- Uncommon etiologies of arrhythmia (e.g., long QT syndrome, hypertrophic cardiomyopathy, Brugada syndrome)
- Cognitive impairment, based on Mini-Mental Status Exam (MMSE) and educational level. If education level is less than 8th grade, then people with an MMSE score of less than 17 will not be enrolled; if education level is greater than 8th grade, then people with an MMSE score of less than 24 will not be enrolled.
Where it is running
- Yale University Medical School — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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