TweeSteden Mild Stenosis Study

Active, not recruiting

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

• Registration Number: NCT01788241
• Lead Sponsor: Tilburg University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2013-01-30
• Study First Submitted QC: 2013-02-07
• Study First Posted: 2013-02-11
• Primary Completion: 2015-04
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-06
• Last Update Posted: 2015-10-07
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 547

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events (MACE)	Average 42 months (Range 12-72; at least 12 months after inclusion final participant)	MACE includes the occurence of a recurrent coronary angiography, emergency hospitalization (for cardiac reasons), myocardial infarction, percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG), mortality (cardiac/noncardiac)
Patient Perceived Health Status	12 and 24 months	patient perceived health status includes self-reported chest pain, disease specific health status, generic health status, fatigue and mood (depression/anxiety). Double time point was included for this outcome measure to examine changes over time, compared to baseline.

Secondary Outcome Measures

Name	Time	Method
Psychosocial factors	baseline, 12 and 24 months	The secondary aim is to investigate the correlation and the stability over time between psychosocial factors, biochemical variables, traditional cardiac risk factors and measures of outcome.; Psychosocial factors include questionnaires as personality scales (Type D personality, Cook-Medley Hostility scale 27 item version), depression (HADS-D at each time point, BDI, CESD-10 and PHQ9 at consecutive time points), anxiety (HADS-A at each time point), fatigue (FAS), global mood scale (Positive and negative affect), generic health status (Short Form 12), specific health status (Seattle Angina Questionnaire). Indicators of education level, marital status, lifestyle factors, and activity level.
Biochemical correlates	baseline, 12 and 24 months	Examine biochemical correlates in relation to psychosocial and traditional cardiac risk factors.; Standard assessment is done for high sensitive C-reactive protein (hsCRP), fibrinogen, leukocyte count and differentiation, and registration of lipid profile, glucose, creatinin at baseline. Baseline and 12 month serum samples are collected and stored at -80, as well as DNA samples for future funding opportunities.

Trial Locations

Locations (1)

TweeSteden Hospital Tilburg; 🇳🇱 Tilburg, Dr. Deelenlaan 5, Netherlands