Tilburg Health Outcomes Registry of Emotional Stress in Coronary Intervention

NCT02621216 | Recruiting DMC

• 2 other identifiers: THORESCINL46259.028.13
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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. 1.To examine the adherence to the prevention and PCI guidelines and the effects thereof on long term prognosis in PCI patients.
2. 2.To evaluate the effectiveness of the psychosocial screening instrument of the European Society of Cardiology Prevention guideline 2012.
3. 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

Coronary Heart Disease

Keywords

percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• PCI complications

  procedure related complications, events and mortality in the first year post-PCI

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients scheduled for either elective or (sub-)acute PCI for ≥1 coronary occlusions

You may qualify if:

• PCI
• Sufficient understanding of Dutch language

You may not qualify if:

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

Sponsors & Collaborators

• Tilburg University: lead
• The Elisabeth-TweeSteden Hospital: collaborator
• Elisabeth-TweeSteden Ziekenhuis: collaborator

Study Sites (1)

Elisabeth-TweeSteden hospital

Tilburg, North Brabant, 5042AD, Netherlands

RECRUITING

Related Publications (1)

• Douma ER, Kop WJ, Kupper N. Associations Between Psychological Factors and Adherence to Health Behaviors After Percutaneous Coronary Intervention: The Role of Cardiac Rehabilitation. Ann Behav Med. 2024 Apr 11;58(5):328-340. doi: 10.1093/abm/kaae008.

  PMID: 38431284 DERIVED

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Nina Kupper, PhD

  Tilburg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nina Kupper, PhD

CONTACT

+31134662956; h.m.kupper@tilburguniversity.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medical Psychology

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 3, 2015
• Study Start: December 4, 2013
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2037
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

NL (1)