|- candidate number||1616|
|- NTR Number||NTR386|
|- Date ISRCTN created||19-dec-2005|
|- date ISRCTN requested||28-okt-2005|
|- Date Registered NTR||13-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||Effects of treating exhaustion in angioplasty patients on new coronary events: Results of the Randomized Exhaustion Trial (EXIT).|
|- Scientific Title||Randomized Exhaustion Intervention Trial.|
|- hypothesis||Behavioural 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) studied||Percutaneous Coronary Intervention (PCI), Exhaustion|
|- Inclusion criteria||Exhausted patients being treated successfully with PCI (reduction in stenosis of >50%).
|- Exclusion criteria||1. 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 received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-1996|
|- planned closingdate||30-apr-2001|
|- Target number of participants||710|
|- Interventions||1. Behavioural intervention including relaxation therapy;|
2. Ususal care.
|- Primary outcome||1. Exhaustion;
2. New coronary event,
'de novo' lesions - all at 18 months follow-up.
|- Secondary outcome||New coronary events (<6 months) versus |
late coronary events (>6 months).
|- Trial web site||http://www.cpsych.org.uk/VE/therapy.htm|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. J.K.L. Denollet|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. J.K.L. Denollet|
|- Sponsor/Initiator ||Dutch Heart Foundation, ZonMw: The Netherlands Organization for Health Research and Development|
(Source(s) of Monetary or Material Support)
|- Publications||Psychosom Med 2005;67:217-223.|
|- Brief summary||Extreme 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)|
|- RECORD||13-sep-2005 - 20-mei-2008|