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Tilburg Health Outcomes Registry of Emotional Stress in Coronary Intervention


- candidate number15837
- NTR NumberNTR4310
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-dec-2013
- Secondary IDsNL46259.028.13 
- Public TitleTilburg Health Outcomes Registry of Emotional Stress in Coronary Intervention
- Scientific TitleTilburg Health Outcomes Registry of Emotional Stress in Coronary Intervention
- ACRONYMTHORESCI
- hypothesisPsychological risk factors will cluster in multiconstruct patient profiles predicting outcome. A network of biological and behavioral mechanisms explain the relationship between these psychological risk clusters and outcome after PCI. The ESC screening instrument may be effective in picking up on general stress and may be implemented as such.
- Healt Condition(s) or Problem(s) studiedMajor adverse events
- Inclusion criteriaelective PCI
aged ≥18
sufficient understanding of the Dutch language to fill out questionnaires
- Exclusion criteriaacute PCI
Life threatening comorbidity (e.g. metastasized cancer)
Acute infection or fever (Biomarker substudy only (N=700))
Active episode of inflammatory illness such as gout (Biomarker substudy only )
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 4-dec-2013
- planned closingdate1-jan-2029
- Target number of participants3000
- Interventionsnone, this is an observational study
- Primary outcomePredictors: Psychological (risk) factors (depression, anxiety, Type D personality, mindfulness, positive mood), Adherence to follow up care (cardiac rehabilitation, diet) Outcome variables: PCI complications, hospitalizations, events
- Secondary outcomePotential mediators: inflammatory biomarkers, markers of endothelial dysfunction, physical stress recovery (Bicycle test)
- TimepointsPredictor assessment around PCI, 30 days post-PCI, 6, 12 and 24 months post-PCI

Outcome and events screening yearly up to 10 years post-PCI
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. Nina Kupper
- CONTACT for SCIENTIFIC QUERIESDr. Nina Kupper
- Sponsor/Initiator Tilburg University
- Funding
(Source(s) of Monetary or Material Support)
NWO
- Publications
- Brief summaryBackground: Percutaneous coronary interventions (PCI) have become mainstay treatment for acute coronary artery disease and the number of patients receiving PCI is vastly growing. Clinical trials have reported on its efficacy and effects on quality of life and mortality. Guidelines have been constructed for PCI treatment as well as cardiovascular prevention. However, relatively little long-term follow-up studies of large real-world clinical samples exist that have looked at the real-world effects of PCI treatment and adherence to current guidelines. Psychological risk factors are important in determining prognosis after PCI, and undergoing PCI may increase the risk of low mood. To date, studies have examined single psychological risk factors, without taking into account their relatedness. Moreover, guidelines are advocating psychosocial screening in early cardiovascular disease, but the screening test as proposed in the prevention guideline has not yet been validated or tested. Although the detrimental effects of psychological risk factors on cardiovascular prognosis are known, the mechanisms through which they exert these effects are yet unclear. It is to be expected that not one but multiple biological (inflammation, endothelial dysfunction) and behavioural (coping styles, poor self-care, consultation behaviour) pathophysiological processes play a role, and that these processes interact with each other. In PCI patients the mechanisms linking psychological risk to poor prognosis are still to be investigated. Objective of the study: (1) To examine the adherence to the prevention and PCI guidelines and the effects thereof on long term prognosis in PCI patients. (2) To evaluate the effectiveness of the psychosocial screening instrument of the European Society of Cardiology Prevention guideline 2012. (3) To examine effects of clustering psychological risk factors on several networks of potentially mediating mechanisms and long term outcomes in a large sample of PCI patients. Study design: Prospective, observational cohort study Study population: Adult patients undergoing an elective/subacute percutaneous coronary intervention Primary study parameters/outcome of the study: Predictors: Psychological (risk) factors (depression, anxiety, Type D personality, mindfulness, positive mood), Adherence to follow up care (cardiac rehabilitation, diet) Outcome variables: PCI complications, hospitalizations, events Secundary study parameters/outcome of the study (if applicable): Potential mediators: inflammatory biomarkers, markers of endothelial dysfunction, physical stress recovery (Bicycle test) Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable): The risk associated with the current study is very low. For this mechanistic observational study, investigators will ask patients to fill out two extensive (20 pages) and several smaller (12-15 pages) psychological surveys including among others questions on personality, positive and negative mood, mindfulness, work stress, and satisfaction with life. Preferably, questionnaires will be administered digitally by email link. In addition, in a subsample three additional fasting blood samples will be drawn to assess study-specific markers, of which two will coincide with regular blood draws at the clinic. There are no direct benefits of participation, other than providing data to create knowledge to improve future treatment.
- Main changes (audit trail)
- RECORD6-dec-2013 - 3-jan-2014


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