Optimising Risk Assessment with CT-angiography or Calcium Score in patients at high risk for a cardiovascular event.

Recruiting

• Conditions: Atherosclerosis; vascular diseases; 10011082; 10003216

• Registration Number: NL-OMON54796
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 1500

Inclusion Criteria

Patients participating in either SMART or SMART-2 and who have one of the
following:
- History of cardiovascular event (Coronary artery disease, Cerebrovascular
disease, including TIA or Peripheral artery disease, including aortic aneurysm)
- Diabetes Mellitus type 2
- Hypertension

Exclusion Criteria

-Known renal failure (defined as eGFR <30 ml/min/1.73 m2 estimated by MDRD
formula)
-Previous allergic reaction to contrast, making medical intervention necessary
-Other contra-indication for CT-scanning
-Previous exposure to radiation for scientific purposes without advantage for
the patient

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Combined endpoint of cardiovascular events (cardiovascular death, non-fatal<br /><br>myocardial infarction and non-fatal ischemic stroke) </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-Coronary artery intervention (PCI, CABG)<br /><br>-Carotid desobstruction or stenting<br /><br>-Non-fatal rupture, stenting or operation of an abdominal aorta aneurysm ,<br /><br>-Amputation, PTA (percutaneous transluminal angioplastic) or stenting due to<br /><br>peripheral artery disease<br /><br>-All cause mortality </p><br>