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TweeSteden Mild Stenosis Study

NCT01788241 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 547

Last updated 2015-10-07

No results posted yet for this study

Summary

Psychosocial factors have been found to be associated with an increased risk for coronary artery disease incidence, progression and worse clinical outcomes.

Patients with non-significant coronary artery disease (confirmed vascular irregularities, but \<60% coronary occlusion) often present with complaints such as chest pain, which warrant screening by coronary angiography (CAG) or computed tomography (CT scan). The prognosis of this group of patients with mild stenosis remains to be investigated in more detail, and we propose that psychosocial factors play a role in the clinical prognosis and patient reported outcomes in this group.

A special focus lies within examining personality characteristics, of which Type D personality is a primary predictor variable for prognosis. Type D personality is characterised by high negative affect and high social inhibition. In addition to psychosocial factors (personality, mood state, social support, SES), biomarkers(inflammation, clotting, DNA) as well as standard clinical risk factors (metabolic syndrome, activity level, smoking, medication use, disease severity) will be investigated.

The goal of the proposed study is to investigate a preexisting psycho-biochemical risk profile for major adverse cardiovascular events (MACE) and patient perceived symptoms in a group with angiographically or CT-scan confirmed, non-significant coronary artery disease.

Conditions

Sponsors & Collaborators

  • The Elisabeth-TweeSteden Hospital

    collaborator OTHER

  • Elisabeth-TweeSteden Ziekenhuis

    collaborator OTHER

  • Tilburg University

    lead OTHER

Principal Investigators

  • Paula M.C. Mommersteeg, PhD · Tilburg University

  • Jos W. Widdershoven, MD PhD · The Elisabeth-TweeSteden Hospital

  • Wilbert Aarnoudse, MD PhD · The Elisabeth-TweeSteden Hospital

  • Johan Denollet, PhD · Tilburg University

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2015-04-30
Completion
2025-04-30

Countries

  • Netherlands

Study Locations

More Related Trials

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 NCT01788241 on ClinicalTrials.gov