search
Back to results

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

Primary Purpose

Familial Hypercholesterolemia, Familial Hypercholesterolemia Due to Genetic Defect of Apolipoprotein B, Familial Hypercholesterolemia Due to Heterozygous LDL Receptor Mutation

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Research-based genetic test for Familial Hypercholesterolemia
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Familial Hypercholesterolemia focused on measuring 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

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers
  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

Sites / Locations

  • Vancouver General HospitalRecruiting
  • St.Pauls HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Observation

Active-testing

Arm 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.

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

Outcomes

Primary Outcome Measures

Number of patients with a new diagnosis of FH

Secondary Outcome Measures

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
Lowest LDL-cholesterol (LDL-C) level achieved in the first year after ACS
Proportion of patients who achieve guideline recommended lipid targets in the first year after ACS
Canadian Cardiovascular Society Guidelines: LDL-C <1.8 mmol/L European Society of Cardiology Guidelines: ≥50% LDL-C reduction from baseline and LDL-C <1.4 mmol/L

Full Information

First Posted
January 19, 2022
Last Updated
May 14, 2023
Sponsor
University of British Columbia
Collaborators
Genome British Columbia, Vancouver Coastal Health Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT05218005
Brief Title
Advancing Cardiac Care Unit-based Rapid Assessment and Treatment of hypErcholesterolemia
Acronym
ACCURATE
Official Title
The Advancing Cardiac Care Unit-based Rapid Assessment and Treatment of hypErcholesterolemia (ACCURATE) Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Genome British Columbia, Vancouver Coastal Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Non-Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Observation
Arm Type
No Intervention
Arm 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.
Arm Title
Active-testing
Arm Type
Experimental
Arm Description
Those admitted between 6-18 months of the study meeting the inclusion criteria. Saliva samples will be collected for DNA testing.
Intervention Type
Diagnostic Test
Intervention Name(s)
Research-based genetic test for Familial Hypercholesterolemia
Intervention Description
Next-generation targeted sequencing assay to identify DNA variants in genes known to cause Familial Hypercholesterolemia
Primary Outcome Measure Information:
Title
Number of patients with a new diagnosis of FH
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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
Title
Lowest LDL-cholesterol (LDL-C) level achieved in the first year after ACS
Time Frame
1 year
Title
Proportion of patients who achieve guideline recommended lipid targets in the first year after ACS
Description
Canadian Cardiovascular Society Guidelines: LDL-C <1.8 mmol/L European Society of Cardiology Guidelines: ≥50% LDL-C reduction from baseline and LDL-C <1.4 mmol/L
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Rate of recurrent cardiovascular event in the first year after ACS
Description
Unstable angina Myocardial infarction Urgent coronary revascularization Death
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Age <60 years AND Admitted to an acute cardiac unit with either: A ST elevation myocardial infarction (STEMI), or A non-ST elevation myocardial infarction (NSTEMI) AND 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lubomira Cermakova, MSc
Phone
604-806-9624
Email
LCermakova@providencehealth.bc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Navid Saleh
Email
navids97@student.ubc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liam Brunham, MD PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liam R Brunham, MD,PhD
Phone
(604) 682-2344
Ext
63929
Email
liam.brunham@ubc.ca
First Name & Middle Initial & Last Name & Degree
Luba Cermakova
Phone
604-806-9624
Email
lcermakova@providencehealth.bc.ca
Facility Name
St.Pauls Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liam R Brunham, MD
Phone
(604) 682-2344
Ext
63929
Email
liam.brunham@ubc.ca
First Name & Middle Initial & Last Name & Degree
Luba Cermakova, MSc
Phone
604-806-9624
Email
lcermakova@providencehealth.bc.ca

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs