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Modification of Cardiovascular Risk and Management with MSCT coronary imaging

Conditions
Atherosclerosis
coronary artery disease
10011082
Registration Number
NL-OMON31371
Lead Sponsor
eids Universitair Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
450
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

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Primary endpoint<br /><br>Cumulative cardiac death, myocard infarct, unstable angina requiring<br /><br>hospitalization and stroke, during a follow-up period of 5 years.<br /><br><br /><br>The primary endpoint will be compared against an age and gender matched cohort<br /><br>based on a validated computer simulation (based on Rotterdam Study, SCORE,<br /><br>Framingham).</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>1. Proportion of patients with MSCT calcium scores <10, 10-400, >400 (Agatston).<br /><br>2. Proportion of patients reclassified using MSCT as low, intermediate, high or<br /><br>very high risk.<br /><br>3. Reduction of adverse events during 5-year follow-up using MSCT risk<br /><br>stratification as compared to risk stratification without MSCT<br /><br>4. Estimated net costs savings during 5-year follow-up using MSCT risk<br /><br>stratification as compared to risk stratification without MSCT<br /><br>5. Cost-effectiveness of MSCT risk stratification as compared to risk<br /><br>stratification without MSCT<br /><br></p><br>
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