NCT05352386

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2022

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

10 months

First QC Date

April 22, 2022

Last Update Submit

March 13, 2023

Conditions

Familial Hypercholesterolemia

Outcome Measures

Primary Outcomes (2)

  • Total coronary plaque volume (mm3)

    Day 0

  • Total coronary plaque burden (%)

    Day 0

Secondary Outcomes (12)

  • Presence of >50% obstructive stenosis per vessel

    Day 0

  • Presence of <50% nonobstructive stenosis per vessel

    Day 0

  • Calcified coronary plaque volume (mm^3)

    Day 0

  • Calcified coronary plaque burden (%)

    Day 0

  • Non-calcified plaque volume (mm^3)

    Day 0

  • +7 more secondary outcomes

Study Arms (3)

Patients with familial hypercholesterolemia, early treated

OTHER
Diagnostic Test: Coronary computed tomography angiography (CCTA)

Patients without familial hypercholesterolemia, late treated

OTHER
Diagnostic Test: Coronary computed tomography angiography (CCTA)

Healthy individuals

OTHER
Diagnostic Test: Coronary computed tomography angiography (CCTA)

Interventions

Coronary computed tomography angiography (CCTA)DIAGNOSTIC_TEST

Participants undergo coronary computed tomography angiography (CCTA)

Healthy individualsPatients with familial hypercholesterolemia, early treatedPatients without familial hypercholesterolemia, late treated

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed with heterozygous familial hypercholesterolemia or non FH-control
  • Adult patients between 25 and 55 years old.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC, location AMC

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr. E.S.G.Stroes

Study Record Dates

First Submitted

April 22, 2022

First Posted

April 28, 2022

Study Start

March 7, 2022

Primary Completion

December 19, 2022

Study Completion

December 19, 2022

Last Updated

March 14, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)