To demonstrate whether using MSCT to reclassify individuals who are at high-risk based on traditional risk factors.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint:
Difference in risk prediction from MSCT-derived information compared to
traditional risk factors
Primary Outcomes:
1. proportion of patients at high-risk reclassified with CT-calcium score into
low, medium and high-risk
2. proportion of patients at high-risk reclassified with CT-coronary imaging
(total plaque burden) into low,
medium and high-risk
Secondary outcome
Secondary endpoint:
A) combination of cumulative death, non-fatal myocardial infarction or stroke
during 5-year follow-up
B) combination of death, non-fatal myocardial infarction or angina pectoris
(positive stress-test) in patients
with FH
C) all-cause death during 5-year follow-up
Secondary outcomes:
1. risk classification according to calcium score based on coronary tree,
vessel or segment score
2. risk classification according to CT-coronary imaging and total plaque burden
per coronary tree, vessel
and segment.
Background summary
Acute cardiac death or nonfatal myocardial infarction is the first clinical
manifestation of coronary atherosclerosis which occurs in 40% to 50% of
cases[1,2]. Eighty % of CHD mortality in individuals <65 years occurs during the
first heart attack and 57% of men and 64% of women who died suddenly of CHD had
no previous symptoms [3,4] Traditional risk factors are used to define the
statistical likelihood of development of an adverse coronary event, but they
provide no direct evidence of the presence or degree of coronary
atherosclerosis. Traditional risk factors fail to detect an individual who will
suffer a cardiovascular adverse event, necessitating better methods of risk
stratification [5]. Early detection of atherosclerosis itself before symptoms
occur can provide a major opportunity to prevent the occurrence of adverse
cardiac events. The predictive value of traditional risk factors may be
increased by direct non-invasive MSCT-derived demonstration of subclinical
coronary atherosclerosis. MSCT coronary
imaging identifies individuals without or with varying degrees of subclinical
atherosclerosis and this may result in a more precise reclassification of
high-risk individuals based on traditional risk factors into low, medium, high
or very
high-risk groups.This reclassification allows tailoring of the intensity of
risk management proportional to the re-allocated risk group, which may reduce
costs.
Study objective
To demonstrate whether using MSCT to reclassify individuals who are at
high-risk based on traditional risk factors.
Study design
Prospective multicentre blinded observational study of high-risk patients
undergoing CT-coronary imaging with long-term (5 Years) follow-up.
Study burden and risks
The likelihood of additional mortality associated with radiation exposure
causing carcinoma is:
mSv Likelihood mortality
Coronary calcium scan 1.3 - 2.0 1 per 10.000
CT-coronary angiography 4.8 - 14 1 per 4000 to 1 per 1330
Note: these likelihoods are based on persons with age ranging from 0 yrs to 80
yrs. The study population persons are 45 yr to 70 years old. This implicates
that the above mentioned likelihoods may be reduced with approximately 50%.
Side-effects related to the use of X-ray contrast.
Severe: 0.01 : 0.22% (severe allergic reaction with shock)
Total: 1.2 - 2.1% (flush, urticaria etc)
s-Gravendijkwal 230
Rotterdam 3015 CE
NL
s-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
- cardiac asymptomatic patients at high-risk of cardiovascular disease,
- high-risk defined as having:
1. familial hypercholesterolaemia (FH)
2. diabetes mellitus, which is defined as
Whole blood Plasma
Fasting or >= 6.1 (>= 110) >= 7.0 (>= 126)
2-h post glucose load >= 10 (>= 180) >= 11.1 (>= 200)
3. peripheral vascular disease
- age 45-70 years except for men with FH -40 years;Additional specific MSCT criterium: stable heart rate
Exclusion criteria
Exclusion criteria
- Known CAD
- Refractory ventricular arrhythmia
- Other serious medical illness
- Participation in other study
- Additional specific MSCT criteria:
o Renal dysfunction (serum creatinine) > 120 mml/L
o Contrast allergy (hypersensitivity)
o Irregular heart rhythm (atrial fibrillation)
o Fast heart rate (> 75 bpm)
o Severe COPD
o Contra-indication against β-blockade
o Hypotension (<= 90 mmHg)
o Bronchospasm
o Severe LV dysfunction
o Pregnancy
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 | NL16994.078.07 |