Modification of risk with MSCT- coronary angiography in high-risk cardiac asymptomatic patients.

Recruiting

Conditions: Atherosclerosis
coronary artery disease
10011082

Registration Number: NL-OMON39448

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 1000

Inclusion Criteria

- cardiac asymptomatic patients at high-risk of cardiovascular disease,
- high-risk defined as having:
1. familial hypercholesterolaemia (FH)
2. diabetes mellitus, which is defined as
Whole blood Plasma
Fasting or >= 6.1 (>= 110) >= 7.0 (>= 126)
2-h post glucose load >= 10 (>= 180) >= 11.1 (>= 200)
3. peripheral vascular disease
- age 45-70 years except for men with FH -40 years;Additional specific MSCT criterium: stable heart rate

Exclusion Criteria

Exclusion criteria
- Known CAD
- Refractory ventricular arrhythmia
- Other serious medical illness
- Participation in other study
- Additional specific MSCT criteria:
o Renal dysfunction (serum creatinine) > 120 mml/L
o Contrast allergy (hypersensitivity)
o Irregular heart rhythm (atrial fibrillation)
o Fast heart rate (> 75 bpm)
o Severe COPD
o Contra-indication against β-blockade
o Hypotension (<= 90 mmHg)
o Bronchospasm
o Severe LV dysfunction
o Pregnancy

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint:<br /><br>Difference in risk prediction from MSCT-derived information compared to<br /><br>traditional risk factors<br /><br><br /><br>Primary Outcomes:<br /><br>1. proportion of patients at high-risk reclassified with CT-calcium score into<br /><br>low, medium and high-risk<br /><br>2. proportion of patients at high-risk reclassified with CT-coronary imaging<br /><br>(total plaque burden) into low,<br /><br>medium and high-risk</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoint:<br /><br>A) combination of cumulative death, non-fatal myocardial infarction or stroke<br /><br>during 5-year follow-up<br /><br>B) combination of death, non-fatal myocardial infarction or angina pectoris<br /><br>(positive stress-test) in patients<br /><br>with FH<br /><br>C) all-cause death during 5-year follow-up<br /><br><br /><br>Secondary outcomes:<br /><br><br /><br>1. risk classification according to calcium score based on coronary tree,<br /><br>vessel or segment score<br /><br>2. risk classification according to CT-coronary imaging and total plaque burden<br /><br>per coronary tree, vessel<br /><br>and segment.</p><br>