TweeSteden Mild Stenosis Study (TWIST)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
TweeSteden Hospital, Tilburg, the Netherlands
Information provided by (Responsible Party):
Paula M.C. Mommersteeg, University of Tilburg
ClinicalTrials.gov Identifier:
NCT01788241
First received: January 30, 2013
Last updated: December 17, 2013
Last verified: December 2013

January 30, 2013
December 17, 2013
January 2009
May 2015   (final data collection date for primary outcome measure)
  • Major Adverse Cardiac Events (MACE) [ Time Frame: Average 42 months (Range 12-72; at least 12 months after inclusion final participant) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT01788241 on ClinicalTrials.gov Archive Site
  • Psychosocial factors [ Time Frame: baseline, 12 and 24 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: baseline, 12 and 24 months ] [ Designated as safety issue: No ]

    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.

Same as current
Not Provided
Not Provided
 
TweeSteden Mild Stenosis Study
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.

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Serum, DNA, leukocyte differentiation, high-sensitive C-reactive protein, fibrinogen

Probability Sample

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

  • Coronary Artery Disease
  • Non-significant Coronary Artery Disease
  • Mild Stenosis
  • Vascular Irregularities
Not Provided
CAG and CT group
CAG group = patients included based on coronary angiography screening; CT group = patients included based on computed tomography screening
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. 2012 Dec 21. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
573
May 2025
May 2015   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01788241
UVT-MP-003
No
Paula M.C. Mommersteeg, University of Tilburg
University of Tilburg
TweeSteden Hospital, Tilburg, the Netherlands
Principal Investigator: Paula M.C. Mommersteeg, PhD Tilburg University
Principal Investigator: Jos W. Widdershoven, MD PhD TweeSteden Hospital, Tilburg, the Netherlands
Study Chair: Wilbert Aarnoudse, MD PhD TweeSteden Hospital, Tilburg, the Netherlands
Study Chair: Johan Denollet, PhD Tilburg University
University of Tilburg
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP