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

NCT05218005 | Completed

• 1 other identifier: H21-00116
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

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 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of patients with a new diagnosis of definite FH

  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

  15 months

• Lowest LDL-cholesterol (LDL-C) level achieved in the first 15 months after ACS

  15 months

• Proportion of patients who achieve guideline recommended lipid targets in the first 15 months after ACS

  15 months

Other Outcomes (1)

• Rate of recurrent cardiovascular event in the first 15 months after ACS

  15 months

Study Arms (2)

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.

Diagnostic Test: Research-based genetic test for Familial Hypercholesterolemia

Interventions

Research-based genetic test for Familial Hypercholesterolemia DIAGNOSTIC_TEST

Next-generation targeted sequencing assay to identify DNA variants in genes known to cause Familial Hypercholesterolemia

Active-testing

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vancouver Coastal Health Research Institute: collaborator
• University of British Columbia: lead
• Genome British Columbia: collaborator

Study Sites (2)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

St.Pauls Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

MeSH Terms

Conditions

Hyperlipoproteinemia Type II; Acute Coronary Syndrome; Non-ST Elevated Myocardial Infarction; ST Elevation Myocardial Infarction; Hyperlipoproteinemia Type III; Myocardial Infarction

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Liam Brunham, MD PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 1, 2022
• Study Start: January 1, 2022
• Primary Completion: June 17, 2024
• Study Completion: August 29, 2025
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

CA (2)