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NCT05063435 · ClinicalTrials.gov registry record
Cardiovascular Structure and Function in the Mucopolysaccharidoses
A clinical trial of Inflammation and Cardiac Disease, sponsored by Children's Hospital of Orange County.
- Active
- Registry status
- 30
- Enrollment target
- 1
- Study location
NCT05063435 is a study of Inflammation and Cardiac Disease that is active but no longer recruiting, run by Children's Hospital of Orange County. The registered enrollment target is 30 participants, below the 288-participant average among 132 other Inflammation trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05063435, a study of Inflammation and Cardiac Disease, is active but no longer recruiting, sponsored by Children's Hospital of Orange County.
- ACTIVE NOT RECRUITING
- Registry status
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This study's investigators previously demonstrated the potential utility of non-invasive carotid ultrasonography to calculate carotid intima media thickness (cIMT) and stiffness (as measured by the three parameters, carotid cross-sectional distensibility \[cCSD\], carotid cross-sectional compliance \[cCSC\], and carotid incremental elastic modulus \[cIEM\]) in people with mucopolysaccharidoses (MPS). Investigators also studied arterial gene expression in animal models of MPS, and identified upregulation of a number of markers potentially tied to atherosclerosis and inflammation. These include the atherosclerotic marker known as Clusterin (CLU), Cathepsin S, Elastin, and the inflammatory cytokines interleukin 1-α, interleukin 1-β, interleukin 2, and interleukin 6. Other studies have identified elevation in circulating tumor necrosis factor-α correlating with pain and physical disability in certain mucopolysaccharidoses. Since these studies are cross sectional, and not longitudinal, this study aims to annually measure these previously studied biomarkers (carotid measurements, circulating cytokines, cathepsin S, elastin, and CLU) in a large cohort of MPS patients. This study is a 3-year, prospective, anonymized, longitudinal assessment of cardiovascular structure, function, and circulating biomarkers in patients with mucopolysaccharidoses.
Conditions Studied
Interventions
- PROCEDURE Venipuncture
- DIAGNOSTIC_TEST Carotid ultrasonography
- DIAGNOSTIC_TEST Echocardiography, transthoracic
Study Locations (1)
California
- Children's Hospital of Orange County - Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-10-13 |
| Est. Completion | 2026-06-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05063435
The ClinicalTrials.gov registry entry for NCT05063435 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 288-participant average among 132 other Inflammation trials with a reported enrollment target (90% lower). The listed sponsor is Children's Hospital of Orange County, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Inflammation appearing as the primary indexed condition, and to 3 interventions - of which Venipuncture is the first listed.
NCT05063435 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05063435 about?
NCT05063435 is a clinical study titled "Cardiovascular Structure and Function in the Mucopolysaccharidoses". This study's investigators previously demonstrated the potential utility of non-invasive carotid ultrasonography to calculate carotid intima media thickness (cIMT) and stiffness (as measured by the three parameters, carotid cross-sectional distensibility \[cCSD\], carotid cross-sectional compliance ...
What is the current status of trial NCT05063435?
This trial is currently active not recruiting. The enrollment target is 30 participants. The study started on 2021-10-13. Estimated completion is 2026-06-30.
What conditions does trial NCT05063435 study?
This clinical trial studies the following conditions: Inflammation, Cardiac Disease, Carotid Disease, Mucopolysaccharidoses.
What interventions are being tested in trial NCT05063435?
The interventions under investigation include: Venipuncture (PROCEDURE), Carotid ultrasonography (DIAGNOSTIC_TEST), Echocardiography, transthoracic (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05063435?
This trial is sponsored by Children's Hospital of Orange County, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05063435 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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