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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05218005
Recruitment Status : Recruiting
First Posted : February 1, 2022
Last Update Posted : February 15, 2022
Sponsor:
Collaborators:
Genome British Columbia
Vancouver Coastal Health Research Institute
Information provided by (Responsible Party):
Liam Brunham, University of British Columbia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Familial Hypercholesterolemia Familial Hypercholesterolemia Due to Genetic Defect of Apolipoprotein B Familial Hypercholesterolemia Due to Heterozygous LDL Receptor Mutation Familial Hypercholesterolemia - Heterozygous Acute Coronary Syndrome NSTEMI - Non-ST Segment Elevation MI STEMI Familial Hypercholesterolemia With Hyperlipemia Diagnostic Test: Research-based genetic test for Familial Hypercholesterolemia Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Two sequential groups of patients will be recruited. The first cohort will consist of a control group of patients presenting with acute coronary syndrome who will be treated according to usual standard-of-care. The second cohort will consist of patients presenting with acute coronary syndrome in whom research-based genetic testing for FH will be performed during hospitalization and the results returned to the treating physicians.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Advancing Cardiac Care Unit-based Rapid Assessment and Treatment of hypErcholesterolemia (ACCURATE) Study
Actual Study Start Date : January 1, 2022
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with a new diagnosis of FH [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 1 year ]
  2. Lowest LDL-cholesterol (LDL-C) level achieved in the first year after ACS [ Time Frame: 1 year ]
  3. Proportion of patients who achieve guideline recommended lipid targets in the first year after ACS [ Time Frame: 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


Other Outcome Measures:
  1. Rate of recurrent cardiovascular event in the first year after ACS [ Time Frame: 1 year ]
    1. Unstable angina
    2. Myocardial infarction
    3. Urgent coronary revascularization
    4. Death


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05218005


Contacts
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Contact: Lubomira Cermakova, MSc 604-806-9624 LCermakova@providencehealth.bc.ca
Contact: Navid Saleh navids97@student.ubc.ca

Locations
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Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Liam R Brunham, MD,PhD    (604) 682-2344 ext 63929    liam.brunham@ubc.ca   
Contact: Luba Cermakova    604-806-9624    lcermakova@providencehealth.bc.ca   
St.Pauls Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Liam R Brunham, MD    (604) 682-2344 ext 63929    liam.brunham@ubc.ca   
Contact: Luba Cermakova, MSc    604-806-9624    lcermakova@providencehealth.bc.ca   
Sponsors and Collaborators
University of British Columbia
Genome British Columbia
Vancouver Coastal Health Research Institute
Investigators
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Principal Investigator: Liam Brunham, MD PhD University of British Columbia
More Information
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Responsible Party: Liam Brunham, Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT05218005    
Other Study ID Numbers: H21-00116
First Posted: February 1, 2022    Key Record Dates
Last Update Posted: February 15, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Liam Brunham, University of British Columbia:
Familial hypercholesterolemia
hyperlipoproteinemia Type II
hyperlipoproteinemia type 2
familial hypercholesterolaemia
myocardial infarction
acute coronary syndrome
ST-elevated myocardial infarction
STEMI
non-ST-elevation myocardial infarction
NSTEMI
heart attack
 genetic investigation
genetic testing
proprotein convertase subtilisin kexin 9
PCSK9
low-density lipoprotein receptor
LDLR
apolipoprotein B
APOB
low-density lipoprotein cholesterol
LDL-C
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Hyperlipoproteinemia Type II
Hyperlipoproteinemia Type III
Hypercholesterolemia
Hyperlipidemias
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
 Vascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias