Modification of Cardiovascular Risk and Management with MSCT coronary imaging

Modification of Cardiovascular Risk and Management with MSCT coronary imaging - MSCT to improve cardiovascular management

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON31371

Enrollment

450

Registered

2007-10-03

Start date

2007-09-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis coronary artery disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. Proportion of patients with MSCT calcium scores 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	—

Measure

Time frame

1. Proportion of patients with MSCT calcium scores 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

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Countries

Netherlands

Outcome results