None listed
Conditions
Brief summary
The proposed study will be the first randomized controlled trial (RCT) of the use of CCS, and will be targeted to 40-70 year old 1st degree relatives of patients with CAD onset <60 years old, or 2nd degree relatives of patients with onset <50 years old. Control patients will undergo standard risk scoring but have blinded CCS results. In the intervention arm, treatment will be initiated based on CCS, applying the new ACC/AHA prevention guidelines. At three years, the effectiveness of intervention will be assessed on change in plaque volume at CT coronary angiography (CTCA), the extent of which has been strongly linked to outcome. The results will provide high-level evidence to inform the guidelines regarding the place of CTCA in risk assessment, specifically in patients with a family history of premature CAD.
Interventions
A computed tomography (CT) scan is a 30 min assessment obtained at baseline and 3 year follow-up.
This is an Xray picture undertaken by lying in a computed tomography (CT) scanner. The coronary calcium score is obtained by automatic measurement of the density and extent of Xray findings caused by calcium. A CT coronary angiogram is obtained at the same time.
The coronary calcium score is used to identify subjects with early coronary artery disease. Those randomized to the treatment arm will be s
A computed tomography (CT) scan is a 30 min assessment obtained at baseline and 3 year follow-up. This is an Xray picture undertaken by lying in a computed tomography (CT) scanner. The coronary calcium score is obtained by automatic measurement of the density and extent of Xray findings caused by calcium. A CT coronary angiogram is obtained at the same time. The coronary calcium score is used to identify subjects with early coronary artery disease. Those randomized to the treatment arm will be started on oral atovastatin 40 mg/d for the duration of the trial. Intolerance of this dose will lead to down-titration to atovastatin 20mg. If still intolerant, rosuvastatin 10 mg/d or pravastatin 40mg will be tried. If the subject remains intolerant, statin will be stopped but the subject will remain in the trial for intention to treat analysis.
Sponsors
Baker-IDI Heart and Diabetes Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Healthy volunteers
Yes
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)
Outcome results
None listed