Clinical trial NCT05218005: Advancing Cardiac Care Unit-based Rapid Assessment and Treatment of hypErcholesterolemia
Official title: The Advancing Cardiac Care Unit-based Rapid Assessment and Treatment of hypErcholesterolemia (ACCURATE) Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
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
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Genome British Columbia
name: Vancouver Coastal Health Research Institute
First posted: 2022-02-01
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Number of patients with a new diagnosis of FH
timeFrame: 1 year
Secondary outcomes:
measure: 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
timeFrame: 1 year
measure: Lowest LDL-cholesterol (LDL-C) level achieved in the first year after ACS
timeFrame: 1 year
measure: Proportion of patients who achieve guideline recommended lipid targets in the first year after ACS
timeFrame: 1 year
Other outcomes:
measure: Rate of recurrent cardiovascular event in the first year after ACS
timeFrame: 1 year
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: St.Pauls Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Liam Brunham, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: