TweeSteden Mild Stenosis Study

Coronary Artery Disease Clinical Trial

— TWIST  

Official title:

A Psycho-biochemical Perspective on Non-significant Coronary Artery Disease: a Prospective Cohort Study of Classic and Novel Risk Markers.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01788241
• Other study ID #: UVT-MP-003
• Status: Active, not recruiting
• Phase: N/A
• First received: January 30, 2013
• Last updated: October 6, 2015
• Start date: January 2009
• Est. completion date: April 2025

Study information

• Verified date: October 2015
• Source: University of Tilburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 547
• Est. completion date: April 2025
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Constriction, Pathologic
• Coronary Artery Disease
• Coronary Disease
• Mild Stenosis
• Myocardial Ischemia
• Non-significant Coronary Artery Disease
• Vascular Irregularities

Locations

Country	Name	City	State
Netherlands	TweeSteden Hospital Tilburg	Tilburg	Dr. Deelenlaan 5

Sponsors (3)

Lead Sponsor	Collaborator
University of Tilburg	Elisabeth-TweeSteden Ziekenhuis, The Elisabeth-TweeSteden Hospital

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

Mommersteeg PM, Meeuwis SH, Denollet J, Widdershoven JW, Aarnoudse W, Westerhuis BL, Kop WJ. C-reactive protein and fibrinogen in non-obstructive coronary artery disease as related to depressive symptoms and anxiety: findings from the TweeSteden Mild Sten — View Citation

Mommersteeg PM, Pot I, Aarnoudse W, Denollet J, Widdershoven JW. Type D personality and patient-perceived health in nonsignificant coronary artery disease: the TWeesteden mIld STenosis (TWIST) study. Qual Life Res. 2013 Oct;22(8):2041-50. doi: 10.1007/s11 — View Citation

Mommersteeg PM, Widdershoven JW, Aarnoudse W, Denollet J. Personality subtypes and chest pain in patients with nonobstructive coronary artery disease from the TweeSteden Mild Stenosis study: mediating effect of anxiety and depression. Eur J Pain. 2016 Mar — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiac Events (MACE)	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)	Average 42 months (Range 12-72; at least 12 months after inclusion final participant)	No
Primary	Patient Perceived Health Status	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.	12 and 24 months	No
Secondary	Psychosocial factors	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.	baseline, 12 and 24 months	No
Secondary	Biochemical correlates	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.	baseline, 12 and 24 months	No

External Links

•   CoRPS: Center of Research on Psychology in Somatic diseases. Primary funding for the TWIST study.
•   TweeSteden Hospital, Tilburg, the Netherlands. Study location and CoRPS collaboration [Site in Dutch]