The design and rationale of the Advancing Cardiac Care Unit-based Rapid Assessment and Treatment of
Junran J Peng1, Navid Saleh1, Thomas M Roston1
1Department of Medicine, University of British Columbia, Vancouver, BC, Canada.
Insights
Opportunistic genetic testing for familial hypercholesterolemia (FH) in acute coronary syndrome (ACS) patients can increase FH diagnosis. This approach aims to improve outcomes for this common inherited cardiovascular disorder.
Area of Science:
- Cardiovascular Medicine
- Genetics
- Clinical Trials
Background:
- Familial hypercholesterolemia (FH) is a prevalent inherited disorder causing high LDL-C and premature cardiovascular disease.
- Despite its prevalence, FH remains significantly underdiagnosed and undertreated globally.
- Early diagnosis and treatment are crucial for preventing atherosclerotic cardiovascular disease (ASCVD) events.
Purpose of the Study:
- To evaluate the effectiveness of opportunistic genetic testing for FH in hospitalized acute coronary syndrome (ACS) patients.
- To determine if genetic testing increases FH diagnosis rates and improves lipid-lowering therapy intensification.
- To assess the impact of genetic testing on achieving lipid targets and reducing LDL-C levels post-ACS.
Main Methods:
- The ACCURATE study is a non-randomized, controlled trial involving patients under 60 admitted with ACS and elevated LDL-C.
- A control group receives standard care, while an intervention group undergoes genetic testing for FH during hospitalization.
- Outcomes include new FH diagnoses, lipid-lowering therapy intensification, LDL-C levels, and guideline target achievement over 12 months.
Main Results:
- Primary endpoint: Number of patients with a new FH diagnosis.
- Secondary endpoints: Proportion of patients with intensified lipid-lowering therapy, lowest achieved LDL-C, and proportion reaching lipid targets within 12 months post-ACS.
Conclusions:
- The ACCURATE study is the first clinical trial testing genetic testing for FH in the acute cardiac care setting.
- Findings are expected to guide strategies for improving FH diagnosis and treatment.
- This research may lead to better management of inherited hypercholesterolemia and reduce ASCVD risk.
Abstract:
Familial hypercholesterolemia (FH) is an inherited condition characterized by elevated low-density lipoprotein cholesterol (LDL-C) levels and premature atherosclerotic cardiovascular disease (ASCVD). Despite being the most common inherited cardiovascular disorder, it is still highly underdiagnosed and undertreated worldwide. We designed the Advancing Cardiac Care Unit-based Rapid Assessment and Treatment of hypErcholesterolemia (ACCURATE) study to test the hypothesis that opportunistic genetic testing for FH among patients hospitalized for acute coronary syndrome (ACS) will increase the diagnosis of FH and improve patient outcomes. ACCURATE is a non-randomized, controlled trial of patients <60 years old admitted to an acute cardiac unit with ACS and elevated LDL-C levels. The first cohort will consist of a control group of patients presenting with ACS who will be treated according to usual standard-of-care. The second cohort will consist of patients presenting with ACS in whom research-based genetic testing for FH will be performed during hospitalization and the results returned to the treating physicians. The primary endpoint will be the number of patients with a new diagnosis of FH. The secondary endpoints will be the proportion of patients who undergo intensification of lipid-lowering therapy, the lowest LDL-C level achieved, and the proportion of patients reaching guideline recommended lipid targets in the 12 months after the index ACS. To our knowledge, ACCURATE represents the first clinical trial of genetic testing for FH in the acute cardiac care setting and is expected to help identify optimal approaches to increase the diagnosis and treatment of FH.
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