TweeSteden Mild Stenosis Study (TWIST)
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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. |
- 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.
- 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: | 547 |
| 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 |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01788241
| Netherlands | |
| TweeSteden Hospital Tilburg | |
| Tilburg, Dr. Deelenlaan 5, Netherlands, 5042 AD | |
| 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: | February 11, 2015 |
| 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 Coronary Disease Myocardial Ischemia Arterial Occlusive Diseases |
Arteriosclerosis Cardiovascular Diseases Heart Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on March 03, 2015