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
  Purpose

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
Coronary Artery Disease
Non-significant Coronary Artery Disease
Mild Stenosis
Vascular Irregularities

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by University of Tilburg:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.



Biospecimen Retention:   Samples With DNA

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


Enrollment: 573
Study Start Date: January 2009
Estimated Study Completion Date: May 2025
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
CAG and CT group
CAG group = patients included based on coronary angiography screening; CT group = patients included based on computed tomography screening

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01788241

Locations
Netherlands
TweeSteden Hospital Tilburg
Tilburg, Dr. Deelenlaan 5, Netherlands, 5042 AD
Sponsors and Collaborators
University of Tilburg
TweeSteden Hospital, Tilburg, the Netherlands
Investigators
Principal Investigator: Paula M.C. Mommersteeg, PhD Tilburg University
Principal Investigator: Jos W. Widdershoven, MD PhD TweeSteden Hospital, Tilburg
Study Chair: Wilbert Aarnoudse, MD PhD TweeSteden Hospital Tilburg
Study Chair: Johan Denollet, PhD Tilburg University
  More Information

Additional Information:
Publications:
Responsible Party: Paula M.C. Mommersteeg, Assistant Professor, University of Tilburg
ClinicalTrials.gov Identifier: NCT01788241     History of Changes
Other Study ID Numbers: UVT-MP-003
Study First Received: January 30, 2013
Last Updated: December 17, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by University of Tilburg:
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
Chest pain
Cardiac risk factors
Metabolic Syndrome
BMI
Obesity
Waist Circumference
Lifestyle
Smoking
Alcohol use
Activity

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

ClinicalTrials.gov processed this record on September 22, 2014