An observational study in Coronary Heart Disease, sponsored by Tilburg University. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-15.
Sponsored by Tilburg University · Observational
Background of the study:
Percutaneous coronary interventions (PCI) have become mainstay treatment for acute coronary artery disease and the number of patients receiving PCI is vastly growing. 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:
Rationale: 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 the 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.
Moreover, 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 ESC 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) pathological 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: (1) To examine the adherence to the prevention and PCI guidelines and the effects thereof on long term prognosis in PCI patients. (2) 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. (3) To evaluate the effectiveness of the psychosocial screening instrument of the European Society of Cardiology Prevention guideline 2012. Study design: Prospective observational cohort study. Study population: All patients aged >18 admitted to the TweeSteden hospital for percutaneous coronary intervention are eligible. Main study parameters/endpoints: Predictors: Psychological (risk) factors (depression, anxiety, Type D personality, mindfulness, positive mood), Adherence; Outcome variables: PCI complications, hospitalizations, events. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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 then 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. There are no direct benefits of participation, other than providing data to create knowledge to improve future treatment.
1,520 studies on the registry are indexed under Coronary Disease; 167 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 916 across 478 observational studies indexed under Coronary Disease.
Browse Coronary Disease studies →Tilburg University is the lead sponsor of 27 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients scheduled for either elective or (sub-)acute PCI for ≥1 coronary occlusions
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
PCI complications
procedure related complications, events and mortality in the first year post-PCI
Time frame: 1 year
PDFs hosted by the registry, ClinicalTrials.gov.
Started Dec 2013 (actual). Primary completion is estimated for Dec 2027, 168 months after the start.
Of 132 non-industry observational studies under Coronary Disease, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 192. This study's planned 168 months is above that.
Counting every sponsor, half of 154 studies reached it within 47 months; a quarter within 21 and three quarters within 123.
How these figures are worked out, and which studies are left out of them.
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Tilburg University