TweeSteden Mild Stenosis Study (TWIST)

Tilburg University

Status: Active, not recruiting

Conditions: Coronary Artery Disease; Vascular Irregularities; Mild Stenosis; Non-significant Coronary Artery Disease

Study type: Observational

Funder types: Other

Identifiers

NCT01788241

UVT-MP-003

Details and patient eligibility

About

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.

Enrollment: 547 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

547 participants in 1 patient group

CAG and CT group

Description:

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