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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2025-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Active-testing

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

Group Type EXPERIMENTAL

Research-based genetic test for Familial Hypercholesterolemia

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Research-based genetic test for Familial Hypercholesterolemia

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No