TweeSteden Mild Stenosis Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

547 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2025-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Artery Disease Non-significant Coronary Artery Disease Mild Stenosis Vascular Irregularities

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CAG and CT group

CAG group = patients included based on coronary angiography screening; CT group = patients included based on computed tomography screening

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Based on quantitative coronary angiography (CAG): visible, but non-significant (\<60% coronary occlusion) vascular irregularities and mild coronary stenosis.
* Based on 64-slice CT-scan (CT-scan): detected non-significant stenosis (calcium score \>= lowest 10th percentile), and not eligible for CAG.

Exclusion Criteria

* Normal coronary arteries (based on CAG or CT scan)
* Significant occlusion of coronary arteries (\>=60% stenosis)
* Eligible for coronary intervention such as PCI or CABG
* History of coronary events (being either MI,PCI, CABG, heart failure)
* For the CT-screened group: eligible for CAG based on the CT-scan
* Serious comorbid conditions such as chronic kidney failure, or receiving chemotherapy
* Insufficient knowledge of the Dutch language

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No