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

Not Applicable

Recruiting

• Conditions: Acute Coronary Syndrome; STEMI; NSTEMI - Non-ST Segment Elevation MI; Familial Hypercholesterolemia With Hyperlipemia; Familial Hypercholesterolemia Due to Genetic Defect of Apolipoprotein B; Familial Hypercholesterolemia Due to Heterozygous LDL Receptor Mutation; Familial Hypercholesterolemia; Familial Hypercholesterolemia - Heterozygous
• Interventions: Diagnostic Test: Research-based genetic test for Familial Hypercholesterolemia

• Registration Number: NCT05218005
• Lead Sponsor: University of British Columbia

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-01-19
• Study First Submitted QC: 2022-01-19
• Study First Posted: 2022-02-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-14
• Last Update Posted: 2023-05-16
• Primary Completion: 2024-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Active-testing	Research-based genetic test for Familial Hypercholesterolemia	Those admitted between 6-18 months of the study meeting the inclusion criteria. Saliva samples will be collected for DNA testing.

Primary Outcome Measures

Name	Time	Method
Number of patients with a new diagnosis of FH	1 year

Secondary Outcome Measures

Name	Time	Method
Proportion of patients in whom lipid-lowering medication intensified, as defined by an increase the dose of statin, or the addition of a non-statin lipid-lowering medication, in the first year after ACS	1 year
Lowest LDL-cholesterol (LDL-C) level achieved in the first year after ACS	1 year
Proportion of patients who achieve guideline recommended lipid targets in the first year after ACS	1 year	1. Canadian Cardiovascular Society Guidelines: LDL-C \<1.8 mmol/L; 2. European Society of Cardiology Guidelines: ≥50% LDL-C reduction from baseline and LDL-C \<1.4 mmol/L

Trial Locations

Locations (2)

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

St.Pauls Hospital; 🇨🇦 Vancouver, British Columbia, Canada