TweeSteden Mild Stenosis Study (TWIST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01788241
Recruitment Status : Active, not recruiting
First Posted : February 11, 2013
Last Update Posted : October 7, 2015
The Elisabeth-TweeSteden Hospital
Elisabeth-TweeSteden Ziekenhuis
Information provided by (Responsible Party):
Paula M.C. Mommersteeg, University of Tilburg

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.

Condition or disease
Coronary Artery Disease Non-significant Coronary Artery Disease Mild Stenosis Vascular Irregularities

Study Type : Observational
Actual Enrollment : 547 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Psycho-biochemical Perspective on Non-significant Coronary Artery Disease: a Prospective Cohort Study of Classic and Novel Risk Markers.
Study Start Date : January 2009
Actual Primary Completion Date : April 2015
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Major Adverse Cardiac Events (MACE) [ Time Frame: 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)

  2. Patient Perceived Health Status [ Time Frame: 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 :
  1. Psychosocial factors [ Time Frame: 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.

  2. Biochemical correlates [ Time Frame: 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.

Biospecimen Retention:   Samples With DNA
Serum, DNA, leukocyte differentiation, high-sensitive C-reactive protein, fibrinogen

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients who have received coronary angiography or computed tomography at the TweeSteden Hospital Tilburg are being screened since January 2009.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01788241

TweeSteden Hospital Tilburg
Tilburg, Dr. Deelenlaan 5, Netherlands, 5042 AD
Sponsors and Collaborators
University of Tilburg
The Elisabeth-TweeSteden Hospital
Elisabeth-TweeSteden Ziekenhuis
Principal Investigator: Paula M.C. Mommersteeg, PhD Tilburg University
Principal Investigator: Jos W. Widdershoven, MD PhD The Elisabeth-TweeSteden Hospital
Study Chair: Wilbert Aarnoudse, MD PhD The Elisabeth-TweeSteden Hospital
Study Chair: Johan Denollet, PhD Tilburg University

Additional Information:
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Paula M.C. Mommersteeg, Assistant Professor, University of Tilburg Identifier: NCT01788241     History of Changes
Other Study ID Numbers: UVT-MP-003
First Posted: February 11, 2013    Key Record Dates
Last Update Posted: October 7, 2015
Last Verified: October 2015

Keywords provided by Paula M.C. Mommersteeg, University of Tilburg:
coronary artery disease
Coronary Stenosis
Cardiovascular Diseases
Non-significant coronary artery disease
Mild Stenosis
Vascular Irregularities
Psychosocial factors
Type D personality
Social Support
Socioeconomic Status
Patient Reported Outcomes
Patient Perceived Symptoms
Health Status
Quality of Life
Chest pain
Cardiac risk factors
Metabolic Syndrome
Waist Circumference
Alcohol use

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Constriction, Pathologic
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Pathological Conditions, Anatomical