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. |
| ClinicalTrials.gov Identifier: NCT01788241 |
|
Recruitment Status
:
Active, not recruiting
First Posted
: February 11, 2013
Last Update Posted
: October 7, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| Group/Cohort |
|---|
|
CAG and CT group
CAG group = patients included based on coronary angiography screening; CT group = patients included based on computed tomography screening
|
- 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)
- 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.
- 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.
- 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
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
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 ClinicalTrials.gov identifier (NCT number): 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 | 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 ClinicalTrials.gov Identifier (NCT Number):
| 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 |
| 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 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 |