- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00627263
Stress Reduction to Reduce Risk for Arrhythmia in ICD Patients (The RISTA Study) (RISTA)
Reducing Vulnerability to ICD Shock Treated Ventricular Arrhythmias
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Connecticut
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New Haven, Connecticut, Stati Uniti, 06520
- Yale University Medical School
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Nessun intervento: 1
Participants will receive the usual cardiologic care for ICD patients provided by their medical team.
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Sperimentale: 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).
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The SRT program is a cognitive behavioral program that consists of 8 group sessions over a period of 10 weeks.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
ICD shock-treated ventricular arrhythmia event-free survival
Lasso di tempo: Measured at Month 24
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The occurrence of ICD shock treated ventricular arrhythmia
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Measured at Month 24
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Laboratory stress-provoked arrhythmogenic changes in the heart rhythm
Lasso di tempo: Measured at Baseline and Month 6
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Arrhythmogenic changes in the heart rhythm during laboratory mental stress
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Measured at Baseline and Month 6
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24-hour heart rate variability
Lasso di tempo: Measured at Baseline and Month 6
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Heart rate variability on 24 hour holter monitoring
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Measured at Baseline and Month 6
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Quality of life
Lasso di tempo: Measured at Month 24
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SF-36 assessment
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Measured at Month 24
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Matthew M. Burg, PhD, Yale University
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 0708003000
- R01HL084438 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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Prove cliniche su Stress reduction treatment (SRT) program
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Massachusetts General HospitalNational Institutes of Health (NIH); National Center for Complementary and Integrative...ReclutamentoEmicraniaStati Uniti
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Universidad de GranadaChair in Conscience and Development (UGR); Mind, Brain and Behaviour Research...CompletatoAnsia | Disagio psicologico | Perfezionismo | Attenzione | Empatia | Creatività | Stress della vita | Intelligenza emotivaSpagna