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Tilburg Health Outcomes Registry of Emotional Stress in Coronary Intervention

NCT02621216 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2024-04-15

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • The Elisabeth-TweeSteden Hospital

    collaborator OTHER

  • Elisabeth-TweeSteden Ziekenhuis

    collaborator OTHER

  • Tilburg University

    lead OTHER

Principal Investigators

  • Nina Kupper, PhD · Tilburg University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-04
Primary Completion
2027-12-31
Completion
2037-12-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02621216 on ClinicalTrials.gov