Trial record 2 of 702 for:    Open Studies | "Arrhythmias, Cardiac"

Stress Reduction Program to Reduce Abnormal Heart Rhythms Treated With Implantable Cardioverter Defibrillators (The RISTA Study)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Yale University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Matthew Burg, Yale University
ClinicalTrials.gov Identifier:
NCT00627263
First received: February 28, 2008
Last updated: March 30, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Arrhythmias, Cardiac
Behavioral: Stress reduction treatment (SRT) program
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reducing Vulnerability to ICD Shock Treated Ventricular Arrhythmias

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • ICD shock-treated ventricular arrhythmia event-free survival [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Laboratory stress-provoked arrhythmogenic changes in the heart rhythm [ Time Frame: Measured at Baseline and Month 6 ] [ Designated as safety issue: No ]
  • 24-hour heart rate variability [ Time Frame: Measured at Baseline and Month 6 ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 304
Study Start Date: January 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Participants will receive the usual cardiologic care for ICD patients provided by their medical team.
Experimental: 2
In 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).
Behavioral: Stress reduction treatment (SRT) program
The SRT program is a cognitive behavioral program that consists of 8 group sessions over a period of 10 weeks.

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 delivering an electrical shock to the heart. The ICD continuously monitors heartbeats to ensure that they are normal, and it only delivers a shock to the heart when it senses a life-threatening arrhythmia. Because of the recent funding approval by Medicaid, it is now estimated that more than 500,000 people will receive ICDs annually. Although ICDs are life-saving medical devices, some people may experience anxiety, depression, and impaired quality of life as a result of the repeated ICD shocks. Additionally, increased mental and emotional stress and anger may increase the likelihood of experiencing more arrhythmias requiring an ICD shock. SRT programs that encourage people to manage their emotions may decrease the frequency of arrhythmias. Furthermore, SRT programs have been shown to be successful at reducing other stress-related heart conditions. The purpose of this study is to evaluate the effectiveness of an SRT program at reducing the incidence of ICD shock-treated arrhythmias among people with newly implanted ICDs.

This study will enroll people who have recently received an ICD. Initially, participants will complete questionnaires about mood and attitudes. Next, at a baseline study visit, participants will complete a mental stress exercise in which they will perform math problems and describe an experience that made them angry. During this exercise, participants will undergo blood pressure measurements, blood collection, and an electrocardiogram (EKG) to measure electrical activity of the heart. Participants will also wear a monitor for 24 hours after the study visit to record heart activity. Participants will then be randomly assigned to either take part in the SRT group and receive usual care or only receive usual care. For 10 weeks, participants in the SRT group will attend 8 group sessions that will focus on learning and applying stress reduction techniques to everyday living. All participants will attend a 3-month follow-up visit for repeat baseline testing. At Months 6, 12, and 24, participants will complete questionnaires during routine doctor's visits or by mail.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00627263

Contacts
Contact: Matthew M. Burg, PhD 203-737-1800 matthew.burg@yale.edu
Contact: Joanne McGloin 203-737-4234 joanne.mcgloin@yale.edu

Locations
United States, Connecticut
Yale University Medical School Recruiting
New Haven, Connecticut, United States, 06520
Principal Investigator: Matthew M. Burg, PhD         
Sub-Investigator: Rachel Lampert, MD         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Matthew M. Burg, PhD Yale University
  More Information

No publications provided by Yale University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Matthew Burg, Associate Clinical Professor of Medicine, Yale University
ClinicalTrials.gov Identifier: NCT00627263     History of Changes
Other Study ID Numbers: 530, R01HL084438-01A1, R01 HL084438-01A1
Study First Received: February 28, 2008
Last Updated: March 30, 2012
Health Authority: United States: Federal Government

Keywords provided by Yale University:
ICD
Cardiac Arrhythmia
Arrhythmia
Stress
Anger

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014