Tilburg Health Outcomes Registry of Emotional Stress in Coronary Intervention

NCT ID: NCT02621216

Last Updated: 2024-04-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-12-04
• Study Completion Date: 2037-12-31

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. 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.

Detailed Description

Rationale: Percutaneous coronary interventions (PCI) have become mainstay treatment for acute coronary artery disease and the number of patients receiving PCI is vastly growing. Clinical trials have reported on the efficacy and effects on quality of life and mortality. Guidelines have been constructed for PCI treatment as well as cardiovascular prevention. 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.

Moreover, 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 ESC 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) pathological 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: (1) To examine the adherence to the prevention and PCI guidelines and the effects thereof on long term prognosis in PCI patients. (2) 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. (3) To evaluate the effectiveness of the psychosocial screening instrument of the European Society of Cardiology Prevention guideline 2012. Study design: Prospective observational cohort study. Study population: All patients aged >18 admitted to the TweeSteden hospital for percutaneous coronary intervention are eligible. Main study parameters/endpoints: Predictors: Psychological (risk) factors (depression, anxiety, Type D personality, mindfulness, positive mood), Adherence; Outcome variables: PCI complications, hospitalizations, events. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risk associated with the current study is very low. For this mechanistic observational study, investigators will ask patients to fill out two extensive (20 pages) and then several smaller (12-15 pages) psychological surveys including among others questions on personality, positive and negative mood, mindfulness, work stress, and satisfaction with life. Preferably, questionnaires will be administered digitally by email link. There are no direct benefits of participation, other than providing data to create knowledge to improve future treatment.

Conditions

Coronary Heart Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• PCI
• Sufficient understanding of Dutch language

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Elisabeth-TweeSteden Hospital

OTHER

Sponsor Role: collaborator

Elisabeth-TweeSteden Ziekenhuis

OTHER

Sponsor Role: collaborator

Tilburg University

OTHER

Sponsor Role: lead

Responsible Party

Nina Kupper PhD

Associate Professor of Medical Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nina Kupper, PhD

Role: PRINCIPAL_INVESTIGATOR

Tilburg University

Locations

Elisabeth-TweeSteden hospital

Tilburg, North Brabant, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Nina Kupper, PhD

Role: CONTACT

h.m.kupper@tilburguniversity.edu

+31134662956

Facility Contacts

Jos Widdershoven, MD, PhD

Role: primary

j.widdershoven@etz.nl

+31134655655

References

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.

Reference Type: DERIVED

PMID: 38431284 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

NL46259.028.13

Identifier Type: OTHER

Identifier Source: secondary_id

THORESCI

Identifier Type: -

Identifier Source: org_study_id