Psychological 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…
Bron
Verkorte titel
Aandoening
percutaneous coronary intervention/ dotterbehandeling
psychosocial risk factors / psychosociale risicofactoren
explanatory mechanisms /
verklarende mechanismen
major adverse events / majeure medische gebeurtenissen
Ondersteuning
Onderzoeksproduct en/of interventie
Geen registraties gevonden.
Uitkomstmaten
Primaire uitkomstmaten
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
Achtergrond van het onderzoek
Background: 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.
Doel van het onderzoek
Psychological 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.
Onderzoeksopzet
Predictor 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
Onderzoeksproduct en/of interventie
none, this is an observational study
Publiek
Dept. of Medical & Clinical Psychology
Tilburg University
Tias Building, room T508
Warandelaan 2
Nina Kupper
Tilburg 5037 AB
The Netherlands
+31 13 466 2956 (2175 secretary's office)
h.m.kupper@tilburguniversity.edu
Wetenschappelijk
Dept. of Medical & Clinical Psychology
Tilburg University
Tias Building, room T508
Warandelaan 2
Nina Kupper
Tilburg 5037 AB
The Netherlands
+31 13 466 2956 (2175 secretary's office)
h.m.kupper@tilburguniversity.edu
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
elective PCI
aged ≥18
sufficient understanding of the Dutch language to fill out questionnaires
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
acute 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 )
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL4121 |
NTR-old | NTR4310 |
CCMO | NL46259.028.13 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |