Describe patterns of biomarkers of vascular inflammation, plaque-instability and hypercoagulability shortly after admission for ACS
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary determinants ('study parameters'): biomarkers of vascular inflammation,
plaque instability and hypercoagulability
Primary endpoint (outcome): absent; this is not an outcome-trial
Secondary outcome
There are no secondary 'study parameters' or endpoints
Background summary
Although current primary and secondary cardiovascular disease (CVD) prevention
programs are effective on group level, they largely fail to identify the
individual who is at high risk of developing an acute coronary syndrome (ACS),
and the period(s) during which this risk is serious and imminent. In fact,
these programs insufficiently utilise knowledge of the pathophysiology of CVD
and ACS. In the lifetime of CVD patients prolonged periods of stability, with
minimal plaque progression and low risk of coronary events, are succeeded by
periods of active (vascular) inflammation and plaque instability, during which
coronary events are highly likely to occur. If these vulnerable periods can be
detected, treatment might be timely intensified to prevent the event from
occurring.
This study is the first in a series in which we will evaluate if biomarkers of
vascular inflammation, plaque-instability and hypercoagulability (repeatedly
measured by blood sampling) can be used to recognise episodes of coronary
vulnerability.
Study objective
Describe patterns of biomarkers of vascular inflammation, plaque-instability
and hypercoagulability shortly after admission for ACS
Study design
This is an observational, descriptive, multicenter clinical trial
Study burden and risks
For the purpose of this study, patients have to visit the outpatient clinic 7
times during a period of 1 year. Four of these visits cannot be considered a
routine control visit.
's Gravendijkwal 230
3015 GD Rotterdam
NL
's Gravendijkwal 230
3015 GD Rotterdam
NL
Listed location countries
Age
Inclusion criteria
- At least 40 years of age
- Admission for an acute coronary syndrome
- At least two of the following high-risk features: age ><=65 (70) in men (women), diabetes mellitus, hypertension, hypercholesterolemia, current smoking, prior angina, prior myocardial infarction, prior cerebrovascular disease, peripheral arterial disease, or microalbuminuria
Exclusion criteria
- Myocardial ischemia precipitated by a condition other than atherosclerotic coronary artery disease
- Severely-impaired left ventricular function or end-stage congestive heart failure NYHA-class III or IV
- Severe chronic kidney disease
- Co-existent condition associated with a life-expectancy <1 year, or otherwise unlikely to appear at all scheduled follow-up visits
Design
Recruitment
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 | NL18076.078.07 |