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

April 27, 2026 updated by: Liam Brunham, University of British Columbia

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

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 definite 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 15 months after the index acute coronary syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 definite 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 15 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 Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St.Pauls Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

  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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Observation
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.
Experimental: Active-testing
Those admitted between 6-18 months of the study meeting the inclusion criteria. Saliva samples will be collected for DNA testing.
Diagnostic test: Research-based genetic test for Familial Hypercholesterolemia
Next-generation targeted sequencing assay to identify DNA variants in genes known to cause Familial Hypercholesterolemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with a new diagnosis of definite FH
Time Frame: 15 months
15 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 15 months after ACS
Time Frame: 15 months
15 months
Lowest LDL-cholesterol (LDL-C) level achieved in the first 15 months after ACS
Time Frame: 15 months
15 months
Proportion of patients who achieve guideline recommended lipid targets in the first 15 months after ACS
Time Frame: 15 months
  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
15 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of recurrent cardiovascular event in the first 15 months after ACS
Time Frame: 15 months
  1. Unstable angina
  2. Myocardial infarction
  3. Urgent coronary revascularization
  4. Death
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Vancouver Coastal Health Research Institute
Genome British Columbia

Investigators

  • Principal Investigator: Liam Brunham, MD PhD, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

June 17, 2024

Study Completion (Actual)

August 29, 2025

Study Registration Dates

First Submitted

January 19, 2022

First Submitted That Met QC Criteria

January 19, 2022

First Posted (Actual)

February 1, 2022

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H21-00116

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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