Clinical trial NCT01788241: TweeSteden Mild Stenosis Study
Official title: A Psycho-biochemical Perspective on Non-significant Coronary Artery Disease: a Prospective Cohort Study of Classic and Novel Risk Markers.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Non-significant Coronary Artery Disease
Mild Stenosis
Vascular Irregularities
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
Chest pain
Cardiac risk factors
Metabolic Syndrome
BMI
Obesity
Waist Circumference
Lifestyle
Smoking
Alcohol use
Activity
Hypertension
Diabetes
Familial Cardiovascular Disease
Coronary angiography
Computed Tomography
Lead sponsor: Tilburg University
Sponsor class: OTHER
Collaborators: name: The Elisabeth-TweeSteden Hospital
name: Elisabeth-TweeSteden Ziekenhuis
First posted: 2013-02-11
Enrollment: 547
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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 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.


Eligibility 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

Primary outcomes:
measure: Major Adverse Cardiac Events (MACE)
timeFrame: Average 42 months (Range 12-72; at least 12 months after inclusion final participant)
measure: Patient Perceived Health Status
timeFrame: 12 and 24 months
Secondary outcomes:
measure: Psychosocial factors
timeFrame: baseline, 12 and 24 months
measure: Biochemical correlates
timeFrame: baseline, 12 and 24 months
Other outcomes:
Locations:
city: Tilburg
country: Netherlands
facility: TweeSteden Hospital Tilburg
state: Dr. Deelenlaan 5
Study officials:
affiliation: Tilburg University
name: Paula M.C. Mommersteeg, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Elisabeth-TweeSteden Hospital
name: Jos W. Widdershoven, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Elisabeth-TweeSteden Hospital
name: Wilbert Aarnoudse, MD PhD
role: STUDY_CHAIR
affiliation: Tilburg University
name: Johan Denollet, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.