Arrhythmias, Cardiac | Stress Reduction Program to Reduce Abnormal Heart Rhythms Treated With Implantable Cardioverter Defibrillators (The RISTA Study)
Arrhythmias, Cardiac research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - 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 Criteria: - 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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Behavioral:Stress reduction treatment (SRT) programThe SRT program is a cognitive behavioral program that consists of 8 group sessions over a period of 10 weeks.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
1Participants will receive the usual cardiologic care for ICD patients provided by their medical team.
2In addition to the usual cardiologic care for ICD patients provided by the participants medical team, those randomized to Intervention will receive the stress reduction treatment (SRT) program (see below).
Start Date: January 2008
Completed Date: December 2012
Phase: Phase 3
Primary Outcome: ICD shock-treated ventricular arrhythmia event-free survival
Secondary Outcome: Laboratory stress-provoked arrhythmogenic changes in the heart rhythm
Study sponsors, principal investigator, and references
Principal Investigator: Matthew M. Burg, PhD
Lead Sponsor: Yale University
Collaborator: National Heart, Lung, and Blood Institute (NHLBI)