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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39448

Enrollment

1000

Registered

2008-01-08

Start date

2008-01-13

Completion date

Unknown

Last updated

2024-06-18

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: - 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: 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 (

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results