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Coronary Artery DiseaseTWISTNCT01788241

TweeSteden Mild Stenosis Study

An observational study of Coronary Artery Disease and Non-significant Coronary Artery Disease, run by Tilburg University at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 20 years and older
How many people
547 participants
Where
1 siteNetherlands
Study dates
Jan 2009to Apr 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients who have received coronary angiography or computed tomography at the TweeSteden Hospital Tilburg are being screened since January 2009.

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Netherlands1 site

  • TweeSteden Hospital Tilburg

    Tilburg, Dr. Deelenlaan 5, 5042 AD

Other trials in Netherlands

About this study

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

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.

Read more

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.

Keywords
coronary artery disease, Atherosclerosis, Coronary Stenosis, Cardiovascular Diseases, Non-significant coronary artery disease, Mild Stenosis, Vascular Irregularities, Psychosocial factors, Personality, Type D personality, Hostility, Depression, Anxiety, Fatigue, Social Support, Socioeconomic Status, Patient Reported Outcomes, Patient Perceived Symptoms, Health Status, Quality of Life
Medical subject headings
Coronary Artery Disease, Atherosclerosis, Coronary Stenosis, Cardiovascular Diseases, Depression, Anxiety Disorders, Fatigue, Chest Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01788241
Study groupRoleWhat they receive
CAG and CT groupCAG group = patients included based on coronary angiography screening; CT group = patients included based on computed tomography screening

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Average 42 months (Range 12-72; at least 12 months after inclusion final participant)

  2. 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.

    Measured: 12 and 24 months

Secondary outcomes (2)

  1. 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.

    Measured: baseline, 12 and 24 months

  2. 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.

    Measured: baseline, 12 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2013 (estimated)
  2. Study startJan 2009
  3. Primary completionApr 2015
  4. Study completionApr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
547 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01788241
Sponsor's protocol ID
UVT-MP-003
Acronym
TWIST
Status last verified
Oct 2015
First submitted
30 Jan 2013
Last updated
7 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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/s11136-012-0340-2. Epub 2012 Dec 21.

    PubMed 23263915

  • 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 Stenosis Study (TWIST). J Psychosom Res. 2014 Nov;77(5):426-9. doi: 10.1016/j.jpsychores.2014.09.020. Epub 2014 Oct 2.

    PubMed 25307791

  • 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;20(3):427-37. doi: 10.1002/ejp.743. Epub 2015 Jun 24.

    PubMed 26105088

  • Mommersteeg PMC, Kupper N, Siebers C, Widdershoven J, Lodder P. Mental Health, Type D Personality, Health Status, and Recurrent Health Care Utilization in Patients With Nonobstructive Coronary Artery Disease. Biopsychosoc Sci Med. 2026 Oct 1;88(8):703-712. doi: 10.1097/PSY.0000000000001519. Epub 2026 Aug 11.

    PubMed 42814520

  • Mommersteeg PMC, Naude PJW, Bagijn W, Widdershoven J, Westerhuis BWJJM, Schoemaker RG. Gender differences in associations of depressive symptoms and anxiety with inflammatory markers in patients with non-obstructive coronary artery disease. J Psychosom Res. 2019 Oct;125:109779. doi: 10.1016/j.jpsychores.2019.109779. Epub 2019 Jul 17.

    PubMed 31421324

  • Mommersteeg PM, Arts L, Zijlstra W, Widdershoven JW, Aarnoudse W, Denollet J. Impaired Health Status, Psychological Distress, and Personality in Women and Men With Nonobstructive Coronary Artery Disease: Sex and Gender Differences: The TWIST (Tweesteden Mild Stenosis) Study. Circ Cardiovasc Qual Outcomes. 2017 Feb;10(2):e003387. doi: 10.1161/CIRCOUTCOMES.116.003387. Epub 2017 Feb 22.

    PubMed 28228453

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Non-significant Coronary Artery Disease, run by Tilburg University at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Adverse Cardiac Events (MACE) (time frame: Average 42 months (Range 12-72; at least 12 months after inclusion final participant)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01788241, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2015.

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TweeSteden Mild Stenosis Study (NCT01788241) | AzTrials