Familial HypercholesterolemiaACCURATENCT05218005
Advancing Cardiac Care Unit-based Rapid Assessment and Treatment of hypErcholesterolemia
A study testing Research-based genetic test for Familial Hypercholesterolemia in people with Familial Hypercholesterolemia and Familial Hypercholesterolemia Due to Genetic Defect of Apolipoprotein B, run by University of British Columbia at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Familial Hypercholesterolemia, Familial Hypercholesterolemia Due to Genetic Defect of Apolipoprotein B, Familial Hypercholesterolemia Due to Heterozygous LDL Receptor Mutation
- What is being tested?
- Research-based genetic test for Familial Hypercholesterolemia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Jan 2022to 29 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
- 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)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
St.Pauls Hospital
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: 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.
Read the 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.
- Conditions
- 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
- Being tested
- Research-based genetic test for Familial Hypercholesterolemia
- 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
- Medical subject headings
- Hyperlipoproteinemia Type II, Acute Coronary Syndrome, Non-ST Elevated Myocardial Infarction, ST Elevation Myocardial Infarction, Hyperlipoproteinemia Type III, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Research-based genetic test for Familial HypercholesterolemiaDiagnostic test
Next-generation targeted sequencing assay to identify DNA variants in genes known to cause Familial Hypercholesterolemia
| Study group | Role | What they receive |
|---|---|---|
| Observation | No intervention | 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 | Those admitted between 6-18 months of the study meeting the inclusion criteria. Saliva samples will be collected for DNA testing. Receives: Diagnostic Test: Research-based genetic test for Familial Hypercholesterolemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with a new diagnosis of definite FH
Measured: 15 months
Secondary outcomes (3)
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
Measured: 15 months
Lowest LDL-cholesterol (LDL-C) level achieved in the first 15 months after ACS
Measured: 15 months
Proportion of patients who achieve guideline recommended lipid targets in the first 15 months 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
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 Jan 2022
- Primary completion17 Jun 2024
- Study completion29 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Familial HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Genome British Columbia, Vancouver Coastal Health Research Institute
- Responsible party
- Principal investigator, Liam Brunham, University of British Columbia
- Investigators
- Liam Brunham, MD PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218005
- Sponsor's protocol ID
- H21-00116
- Acronym
- ACCURATE
- Status last verified
- Apr 2026
- First submitted
- 19 Jan 2022
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vaizman N, Cermakova L, Cooper M, Kramer AI, Hui K, Jackson LM, Roston TM, Mancini GBJ, Fordyce CB, Iatan I, Brunham LR. Opportunistic Genetic Testing for Familial Hypercholesterolemia in Premature Acute Coronary Syndrome: Results of the ACCURATE Study. JACC Adv. 2026 Aug 7;5(9):103053. doi: 10.1016/j.jacadv.2026.103053. Online ahead of print.
PubMed 42567095
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Advancing Cardiac Care Unit-based Rapid Assessment and Treatment of hypErcholesterolemia (ACCURATE) Study
- ClinicalTrials.gov ID
- NCT05218005
- Acronym / sponsor ID
- ACCURATE / H21-00116
- Conditions
- 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
- Keywords
- Familial hypercholesterolemia, hyperlipoproteinemia Type II, hyperlipoproteinemia type 2, familial hypercholesterolaemia, myocardial infarction, acute coronary syndrome, ST-elevated myocardial infarction, STEMI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Genome British Columbia, Vancouver Coastal Health Research Institute
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 17 Jun 2024 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Observation | No intervention | –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 | Diagnostic Test: Research-based genetic test for Familial HypercholesterolemiaThose admitted between 6-18 months of the study meeting the inclusion criteria. Saliva samples will be collected for DNA testing. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Research-based genetic test for Familial HypercholesterolemiaNext-generation targeted sequencing assay to identify DNA variants in genes known to cause Familial Hypercholesterolemia | Diagnostic test | Active-testing |
Primary outcome
Number of patients with a new diagnosis of definite FH
Time frame: 15 months
3 secondary outcomes
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
Lowest LDL-cholesterol (LDL-C) level achieved in the first 15 months after ACS
Time frame: 15 months
Proportion of patients who achieve guideline recommended lipid targets in the first 15 months after ACS
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Derived from this study: PubMed 42567095Vaizman N, Cermakova L, Cooper M, Kramer AI, Hui K, Jackson LM, Roston TM, Mancini GBJ, Fordyce CB, Iatan I, Brunham LR. Opportunistic Genetic Testing for Familial Hypercholesterolemia in Premature Acute Coronary Syndrome: Results of the ACCURATE Study. JACC Adv. 2026 Aug 7;5(9):103053. doi: 10.1016/j.jacadv.2026.103053. Online ahead of print.
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Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liam Brunham, MD PhD principal investigator
University of British Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Research-based genetic test for Familial Hypercholesterolemia in people with Familial Hypercholesterolemia and Familial Hypercholesterolemia Due to Genetic Defect of Apolipoprotein B, run by University of British Columbia at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with a new diagnosis of definite FH (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05218005, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.