Coronary and Heart Effects of Early Treatment in Familial Hypercholesterolemia

NCT ID: NCT05352386

Last Updated: 2023-03-14

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

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-07

Study Completion Date

2022-12-19

Brief Summary

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

Detailed Description

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Conditions

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Familial Hypercholesterolemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients with familial hypercholesterolemia, early treated

Group Type OTHER

Coronary computed tomography angiography (CCTA)

Intervention Type DIAGNOSTIC_TEST

Participants undergo coronary computed tomography angiography (CCTA)

Patients without familial hypercholesterolemia, late treated

Group Type OTHER

Coronary computed tomography angiography (CCTA)

Intervention Type DIAGNOSTIC_TEST

Participants undergo coronary computed tomography angiography (CCTA)

Healthy individuals

Group Type OTHER

Coronary computed tomography angiography (CCTA)

Intervention Type DIAGNOSTIC_TEST

Participants undergo coronary computed tomography angiography (CCTA)

Interventions

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Coronary computed tomography angiography (CCTA)

Participants undergo coronary computed tomography angiography (CCTA)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dutch Heart Foundation

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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E.S.stroes

Prof. dr. E.S.G.Stroes

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Amsterdam UMC, location AMC

Amsterdam, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL79640.018.21

Identifier Type: -

Identifier Source: org_study_id

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