Describe the relation between patterns in biomarkers of vascular inflammation, plaque instability and hypercoagulability and the incidence of recurrent ACS
ID
Source
Brief title
Condition
- Coronary artery disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary determinants ('study parameters'): biomarkers of vascular inflammation,
plaque instability and hypercoagulability
The primary endpoint is a composite of cardiovascular mortality , non-fatal
acute coronary syndrome or unplanned coronary revascularization due to
progressive angina pectoris during 1-year follow-up.
Secondary outcome
Secondary endpoints are
1. A composite of cardiovascular mortality and non-fatal acute coronary
syndrome only;
2. A composite of cardiovascular mortality, non-fatal acute coronary syndrome
and all coronary revascularizations (including staged/planned procedures);
3. A composite of cardiovascular mortality, non-fatal acute coronary syndrome,
unplanned coronary revascularization, re-hospitalization for angina or stroke.
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 the relation between patterns in biomarkers of vascular inflammation,
plaque instability and hypercoagulability and the incidence of recurrent ACS
Study design
This is an observational, descriptive, multicenter clinical trial
Study burden and risks
Patients have to visit the outpatient clinic regulary (maximum 16 times extra
than standard care) during a period of 1 year follow-up.
's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
- At least 40 years of age
-A high-risk profile with regard to the occurrence of primary endpoint during follow-up,
as indicated by the presence of at least 2 points. 2 Points are given in case of presence of one the following risk factors: Age * 75 years, diabetes mellitus, prior angina, prior myocardial infarction, prior cerebrovascular disease, peripheral arterial disease. 1 Point is given in case of presence of one the following risk factors: Age > 65 years in men and > 70 years in women, Hypertension, Hypercholesterolemia, Current smoking, 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 |
|---|---|
| Other | Nederlands Trialregister NTR1698 |
| CCMO | NL17944.078.07 |