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NCT02621216Recruiting

Tilburg Health Outcomes Registry of Emotional Stress in Coronary Intervention

Source: ClinicalTrials.gov · Last updated 15 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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: 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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
3000 (estimated)
First submitted
1 Dec 2015
Start date
4 Dec 2013
Primary completion date
Dec 2027
Lead sponsor
Tilburg University
NCT number
NCT02621216

What you commit to

  • Study type: Observational
  • Planned participants: 3000
  • From 4 Dec 2013 to the primary completion date, Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • life threatening comorbidity (e.g., metastasized cancer)
  • cognitive disorder

Who the study is looking for

  • PCI
  • Sufficient understanding of Dutch language

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Elisabeth-TweeSteden Hospital
Coordinator of this site? Confirm its status
TilburgNetherlandsRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.