Tilburg Health Outcomes Registry of Emotional Stress in Coronary Intervention

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.

NCT Number	NCT02621216
Lead Sponsor	Tilburg University Collaborators: The Elisabeth-TweeSteden Hospital, Elisabeth-TweeSteden Ziekenhuis
Conditions	Coronary Heart Disease
Enrollment	3,000 participants
Start Date	2013-12-04
Primary Completion	2027-12 (estimated)
Study Completion	2037-12 (estimated)
Updated on ClinicalTrials.gov	2024-04-15