Coronary and Heart Effects of Early Treatment in Familial Hypercholesterolemia

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)135 enrolled

Overview

This study evaluates plaque burden and characteristics in early-treated FH patients compared to late-treated FH patients and healthy individuals.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

135

Conditions

Familial Hypercholesterolemia

Interventions

Coronary computed tomography angiography (CCTA)DIAGNOSTIC_TEST

Participants undergo coronary computed tomography angiography (CCTA)

Eligibility

Sex: ALLMin age: 25 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with heterozygous familial hypercholesterolemia or non FH-control * Adult patients between 25 and 55 years old. Exclusion Criteria: * Renal insufficiency, defined as eGFR \< 30 ml/min * Atrial fibrillation * Any other treatment or clinically relevant condition that could interfere with the conduct or interpretation of the study in the opinion of the investigator * Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.

Locations (1)

Amsterdam UMC, location AMC

Amsterdam, Netherlands

Outcomes

Primary Outcomes

Total coronary plaque volume (mm3)

Time frame: Day 0

Total coronary plaque burden (%)

Time frame: Day 0

Secondary Outcomes

Presence of >50% obstructive stenosis per vessel

Time frame: Day 0

Presence of <50% nonobstructive stenosis per vessel

Time frame: Day 0

Calcified coronary plaque volume (mm^3)

Time frame: Day 0

Calcified coronary plaque burden (%)

Time frame: Day 0

Non-calcified plaque volume (mm^3)

Time frame: Day 0

Non-calcified plaque burden (%)

Time frame: Day 0

Low attenuation plaque volume (mm^3)

Time frame: Day 0

Low attenuation plaque burden (%)

Time frame: Day 0

Number of high risk plaque features (positive remodeling, low attenuation plaque, spotty calcification and napkin ring sign)

Time frame: Day 0

Pericoronary adipose tissue attenuation (Hounsfield units)

Time frame: Day 0

Data from ClinicalTrials.gov

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