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Effects of treating exhaustion in angioplasty patients on new coronary events: Results of the Randomized Exhaustion Trial (EXIT).


- candidate number1616
- NTR NumberNTR386
- ISRCTNISRCTN98393380
- Date ISRCTN created19-dec-2005
- date ISRCTN requested28-okt-2005
- Date Registered NTR13-sep-2005
- Secondary IDsN/A 
- Public TitleEffects of treating exhaustion in angioplasty patients on new coronary events: Results of the Randomized Exhaustion Trial (EXIT).
- Scientific TitleRandomized Exhaustion Intervention Trial.
- ACRONYMEXIT
- hypothesisBehavioural intervention in exhausted patients post-PCI is hypothesised to reduce exhaustion and depression, improve quality of life, and improve prognosis.
- Healt Condition(s) or Problem(s) studiedPercutaneous Coronary Intervention (PCI), Exhaustion
- Inclusion criteriaExhausted patients being treated successfully with PCI (reduction in stenosis of >50%).
- Exclusion criteria1. Severe somatic or mental comorbidity;
2. Somtization disorder, fibromyalgia or chronic fatigue;
3. Participation in a behavioural, rehabilitation program other than EXIT;
4. Unsuccessful treatment for a recent depression or panic disorder;
5. Inability to speak Dutch.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blinding[default]
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-1996
- planned closingdate30-apr-2001
- Target number of participants710
- Interventions1. Behavioural intervention including relaxation therapy;
2. Ususal care.
- Primary outcome1. Exhaustion;
2. New coronary event, 'de novo' lesions - all at 18 months follow-up.
- Secondary outcomeNew coronary events (<6 months) versus
late coronary events (>6 months).
- TimepointsN/A
- Trial web sitehttp://www.cpsych.org.uk/VE/therapy.htm
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESProf. Dr. J.K.L. Denollet
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J.K.L. Denollet
- Sponsor/Initiator Dutch Heart Foundation, ZonMw: The Netherlands Organization for Health Research and Development
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsPsychosom Med 2005;67:217-223.
- Brief summaryExtreme fatigue is a common complaint after PCI and is associated with an increased risk of adverse clinical outcome.
The objective of the current study was to determine whether a behavioural intervention on exhaustion reduces the risk of a new coronary event after PCI.
- Main changes (audit trail)
- RECORD13-sep-2005 - 20-mei-2008


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