Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active study of Inflammation and Cardiac Disease, sponsored by Children's Hospital of Orange County.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A cardiovascular event is defined by new onset of clinically significant aortic or mitral valve disease, aortic root dilatation, cardiomyopathy, reduction in cardiac contractile function, myocardial ischemia, myocardial infarction, or cerebrovascular accident
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 |
What the registry record for NCT05063435 still lists
NCT05063435 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 288-participant average among 132 other Inflammation trials with a reported enrollment target (90% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Inflammation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05063435's enrollment target sits among peer trials
30 98th of 132 higher than 27 of 132 other Inflammation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Inflammation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Ketone Ester And Salt (KEAS) in Older Adults
RECRUITING · NA
-
Reducing Suicide Risk Among Aging Caregivers of Persons With AD/ADRD
RECRUITING · NA
-
Reducing Frailty for Older Cancer Survivors Using Supplements II
RECRUITING · Phase 2
-
The Iowa ACEs and Sleep Cohort and Manipulating Sleep in Young Adults With ACEs Studies
RECRUITING · NA
-
Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk
RECRUITING · Phase 3
-
Effects of Daily Beef Intake, as a Component of a Heart-Healthy Diet on Cellular Zinc
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00977977 · 30 participants · Phase 2
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
- NCT01459107 · 30 participants · Phase 2
Human Upper Extremity Allotransplantation
- NCT01666080 · 30 participants · NA
Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)
- NCT01720836 · 30 participants · Phase 1
Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI