Modification of Cardiovascular Risk and Management with MSCT coronary imaging
- Conditions
- Atherosclerosiscoronary artery disease10011082
- 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
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
-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
Name Time Method <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
Name Time Method <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>