Status:
COMPLETED
Stress Reduction to Reduce Risk for Arrhythmia in ICD Patients (The RISTA Study)
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Arrhythmias, Cardiac
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
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...
Detailed Description
An ICD is a device designed to quickly detect a life-threatening, rapid heartbeat. Through a process called defibrillation, the ICD tries to convert an abnormal heart rhythm back to normal by deliveri...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
314 Patients enrolled
Trial Details
Trial ID
NCT00627263
Start Date
January 1 2008
End Date
December 1 2012
Last Update
January 17 2018
Active Locations (1)
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1
Yale University Medical School
New Haven, Connecticut, United States, 06520