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

Acute Coronary Syndrome Clinical Trial

— ACCURATE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05218005
• Other study ID #: H21-00116
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: April 2025

Study information

• Verified date: May 2023
• Source: University of British Columbia
• Contact: Lubomira Cermakova, MSc
• Phone: 604-806-9624
• Email: LCermakova[@]providencehealth.bc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: April 2025
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Familial Hypercholesterolemia
• Familial Hypercholesterolemia - Heterozygous
• Familial Hypercholesterolemia With Hyperlipemia
• Hypercholesterolemia
• Hyperlipidemias
• Hyperlipoproteinemia Type II
• Hyperlipoproteinemia Type III
• NSTEMI - Non-ST Segment Elevation MI
• STEMI

Intervention

Diagnostic Test:
• Research-based genetic test for Familial Hypercholesterolemia
Next-generation targeted sequencing assay to identify DNA variants in genes known to cause Familial Hypercholesterolemia

Locations

Country	Name	City	State
Canada	St.Pauls Hospital	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of British Columbia	Genome British Columbia, Vancouver Coastal Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of recurrent cardiovascular event in the first year after ACS	Unstable angina; Myocardial infarction; Urgent coronary revascularization; Death	1 year
Primary	Number of patients with a new diagnosis of FH		1 year
Secondary	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		1 year
Secondary	Lowest LDL-cholesterol (LDL-C) level achieved in the first year after ACS		1 year
Secondary	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	1 year