Advancing Cardiac Care Unit-based Rapid Assessment and Treatment of hypErcholesterolemia (ACCURATE)

University of British Columbia

Status: Enrolling

Conditions: NSTEMI - Non-ST Segment Elevation MI; Familial Hypercholesterolemia Due to Genetic Defect of Apolipoprotein B; Familial Hypercholesterolemia With Hyperlipemia; Acute Coronary Syndrome; Familial Hypercholesterolemia - Heterozygous; Familial Hypercholesterolemia Due to Heterozygous LDL Receptor Mutation; STEMI; Familial Hypercholesterolemia

Treatments: Diagnostic Test: Research-based genetic test for Familial Hypercholesterolemia

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05218005

H21-00116

Details and patient eligibility

About

ACCURATE will test the hypothesis that opportunistic genetic testing for Familial Hypercholesterolemia (FH) in patients admitted to hospital with an acute coronary syndrome will increase the diagnosis of FH and will impact patient care and outcomes. The study will recruit patients admitted to hospital with an acute coronary syndrome, and research-based genetic testing will be conducted for known FH-causing genetic variants. The results will be returned to the patients' 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 cholesterol level achieved, and the proportion of patients reaching guideline recommended lipid targets in the 12 months after the index acute coronary syndrome.

Full description

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. The Advancing Cardiac Care Unit-based Rapid Assessment and Treatment of hypErcholesterolemia (ACCURATE) study was designed 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. 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Age <60 years

   AND

2. Admitted to an acute cardiac unit with either:

   • A ST elevation myocardial infarction (STEMI), or
   • A non-ST elevation myocardial infarction (NSTEMI)

   AND

3. Maximum lipid level at the time of admission or during the prior 1 year of

   • LDL level ≥4 mmol/L (154 mg/dL) if not on a statin, or
   • LDL-C level ≥2.5 mmol/L (96 mg/dL) if on a statin prior to presentation, or
   • Non-HDL-C ≥4.6 mmol/L (177 mg/dL) if LDL-C not available

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Observation

No Intervention group

Description:

Those admitted in the first 6 months of the study that meet the inclusion criteria. Patients will be treated according to the normal standard of care for acute coronary syndrome.

Active-testing

Experimental group

Description:

Those admitted between 6-18 months of the study meeting the inclusion criteria. Saliva samples will be collected for DNA testing.

Treatment:

Diagnostic Test: Research-based genetic test for Familial Hypercholesterolemia