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
- Diseases
- Coronary artery disease
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Elisabeth-TweeSteden Hospital Coordinator of this site? Confirm its status | Tilburg | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.