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 confirmed, but non-acute, coronary artery…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
MACE (mortality, MI, percutaneous coronary intervention (PCI) or coronary
artery bypass graft surgery (CABG)), and patient perceived symptoms (angina
complaints, fatigue, health status, global mood)
Secondary outcome
The secondary aim is to investigate the correlation and the stability over time
between Type D versus non-Type D persons and biomarkers in patients with
AC-CAD.
Background summary
Type D personality (increased negative affect combined with social inhibition)
is associated with a 4-fold increased risk of mortality and adverse health
outcomes, above and beyond traditional risk factors in patients with
cardiovascular disease (CVD). However, we know little about its mechanisms, or
prognosis in the early development of CVD.
Acute coronary syndromes (ACS) such as unstable angina, or myocardial
infarction (MI) are often the result of a disruption of a stenotic vulnerable
plaque, leading to thrombotic complications. Plaques with moderate (<50%)
stenosis pose a significant risk for ACS development and mortality.
Nevertheless risk stratification in patients with moderate stenosis and
non-acute cardiac symptoms remains largely unexplored.
The atherosclerotic state preceding a cardiovascular event is a systemic
inflammatory disease. An increased inflammatory state as well as prothrombotic
factors are emerging biomarkers for plaque development, instability, and worse
prognosis. Type D personality has been related to an altered inflammatory
profile in chronic heart failure.
Study objective
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 confirmed, but
non-acute, coronary artery disease (AC-CAD). Characterized by mild stenosis and
vascular irregularities.
Study design
Psychosocial variables and biomarkers will be measured at baseline and at one
year. The multifactorial risk profile is based on a personality risk profile
(Type D personality, and other negative affect markers), traditional risk
factors (metabolic syndrome, demographic variables), and biomarkers of
inflammation and thrombosis. MACE and patient perceived symptoms at two-year
follow-up serve as the outcome measures. Finally, the interrelationship between
Type D personality and the biomarkers at baseline and at follow-up will be
assessed to further evaluate preexisting risk factors and their changes over
time.
Study burden and risks
The proposed study incurs no extra risk to patients, as they receive no
additional treatment/ tests no will any treatment be withheld from them
compared to patients who choose not to participate or are excluded on the basis
of the exclusion criteria. Venapunctures (2) will take place, preferentially
combined with standard assessments for the clinical management of patients.
Patients will complete a set of psychological questionnaires, which is
estimated to take 1 hour. These questionnaires can be filled-out at home and
returned by pre-stamped envelope.
Warandelaan 2
5000 LE Tilburg
NL
Warandelaan 2
5000 LE Tilburg
NL
Listed location countries
Age
Inclusion criteria
500 patients from the TweeSteden Hospital Tilburg with angiographically established vascular irregularities (moderate stenosis 10-50%) on one main coronary artery. Potentially eligible patients will be screened based on angiograms and medical records not older than 3 months.
Exclusion criteria
Exclusion criteria: severe coronary stenosis (>50% obstruction), Left main coronary artery plaque < 50%. Previous history of cardiac events, such as MI, PCI or CABG, psychiatric illness other than affective/anxiety disorders, acute infection, being treated with anti-inflammatory drugs other than low-dose aspirin, severe chronic kidney failure (on dialysis or a creatinine level > 250 µmol/liter), chronic systemic disease and treated with corticosteroids or chemotherapy, insufficient knowledge of the Dutch language.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL22258.008.08 |