Trials / Unknown
UnknownNCT01788241
TweeSteden Mild Stenosis Study
A Psycho-biochemical Perspective on Non-significant Coronary Artery Disease: a Prospective Cohort Study of Classic and Novel Risk Markers.
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 547 (actual)
- Sponsor
- Tilburg University · Academic / Other
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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
Timeline
- Start date
- 2009-01-01
- Primary completion
- 2015-04-01
- Completion
- 2025-04-01
- First posted
- 2013-02-11
- Last updated
- 2015-10-07
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT01788241. Inclusion in this directory is not an endorsement.