To demonstrate whether the use of MSCT in addition to traditional risk assessment may improve risk stratification in patients presenting without typical complaints for CAD but an elevated risk profile.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint
Cumulative cardiac death, myocard infarct, unstable angina requiring
hospitalization and stroke, during a follow-up period of 5 years.
The primary endpoint will be compared against an age and gender matched cohort
based on a validated computer simulation (based on Rotterdam Study, SCORE,
Framingham).
Secondary outcome
1. Proportion of patients with MSCT calcium scores <10, 10-400, >400 (Agatston).
2. Proportion of patients reclassified using MSCT as low, intermediate, high or
very high risk.
3. Reduction of adverse events during 5-year follow-up using MSCT risk
stratification as compared to risk stratification without MSCT
4. Estimated net costs savings during 5-year follow-up using MSCT risk
stratification as compared to risk stratification without MSCT
5. Cost-effectiveness of MSCT risk stratification as compared to risk
stratification without MSCT
Background summary
Acute cardiac death or nonfatal myocardial infarction is the first clinical
manifestation of coronary atherosclerosis in 40-50% of cases. Eighty percent of
coronary artery disease (CAD) mortality in individuals <65 years occurs during
the first heart attack. Moreover, 57% of men and 64% of women who died suddenly
of CAD had no previous symptoms that were typical for the presence of CAD.
Traditional risk factors are used to define the statistical likelihood of
development of an adverse coronary event, but they cannot provide direct
evidence of the presence or degree of coronary atherosclerosis. Accordingly,
traditional riskfactors are not exact predictors of risk and more refined
methods are needed. Knowledge of the presence of atherosclerosis would be most
benificial for this purpose and would allow more appropriate risk
stratification. Since recently, direct visualization of atherosclerosis in a
non-invasive and patient-friendly manner has become possible with MSCT
scanning. Accordingly, the use of MSCT may improve risk stratification by
identification of those patients with and without atherosclerosis. By
determining the various degrees of subclinical atherosclerosis, a more precise
reclassification of high-risk patients into low, medium, high or very high-risk
groups. This reclassification may then allow tailoring of risk management and
improve cost-effectiveness.
Study objective
To demonstrate whether the use of MSCT in addition to traditional risk
assessment may improve risk stratification in patients presenting without
typical complaints for CAD but an elevated risk profile.
Study design
prospective study
Study burden and risks
Radiation burden
- calcium scan 1.3 to 2.0 mSv
- CT contrast scan 10-15 mSv
Side-effects contrast agent
- a severe side-effect occurs in 0.01% to 0.22% of all examinations.
Albinusdreef 2
2333 ZA Leiden
NL
Albinusdreef 2
2333 ZA Leiden
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria:
Patients
- without symptoms typical for CAD,
- 45-70 years of age and
- at high-risk for cardiovascular events, defined as having: a >10% risk on cardiovascular mortality and morbidity according to SCORE adjusted for the Netherlands, or diabetes mellitus.
- Stable heart rate as a prerequisite for MSCT
Exclusion criteria
-Known CAD
- Ventricular arrhythmia
- Other serious medical illness
- Participation in other study
- Additional specific MSCT criteria
1. Renal dysfunction (defined as serum creatinine > 120 mmol/L
2. Contrast allergy
3. Irregular heart rhythm
4. Fast heart rate in combination with contra-indications against beta-blocking medication
5. 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 | NL18234.058.07 |