Coronary Artery calcium score: Use to Guide management of Hereditary Coronary Artery Disease

Not Applicable

Recruiting

• Conditions: Coronary artery disease; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12614001294640
• Lead Sponsor: Baker-IDI Heart and Diabetes Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 734

Inclusion Criteria

Asymptomatic subjects age 40-70y
- Family history of CAD involving an index patient <60y (1st degree) or <50y (2nd degree)
- Not already on statins
- Total cholesterol < 6.5 mmol/L and LDL cholestrerol <5 mmol/L
- CAD 5-year risk (Australian risk calculator) 2.5-15%

Exclusion Criteria

- Symptomatic coronary, cerebrovascular, or peripheral vascular disease
- Intolerance of statins or already on statins
- Pre-existing muscle disease (eg polymyositis, fibromyalgia)
- Atrial fibrillation
- Chronic kidney disease on haemodialysis
- Inability to provide informed consent
- Major systemic illness eg malignancy, rheumatoid arthritis
- Women of child bearing potential
- Poorly controlled hypertension: SBP> 200 and or DBP > 100
- Severe psychiatric disorder (eg bipolar depression; psychosis)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in coronary plaque volume is measured by comparison of baseline and 3 year CT coronary angiograms.[3 years]

Secondary Outcome Measures

Name	Time	Method
Cost-effectiveness of CCS in subjects with a CAD family history (based on management costs vs coronary events) in the Australian setting[3 years];Adherence to therapy, assessed by drug tablet return and results of laboratory tests[3 years]