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GlycOxiTOD: Multimodal Vascular and Target-Organ Damage Registry

Study acronym: GlycOxiTOD
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 years 3 months later Dec 31, 2024 → Mar 31, 2031
Primary endpoints removed 10 → 1 primary endpoints
See other at-risk trials from Complejo Hospitalario Universitario de Santiago

Record History

  1. Primary completion pushed from Dec 31, 2024 to Mar 31, 2031 Primary endpoint(s) modified · Enrollment increased: 500 → 1000 participants · Completion pushed from Dec 31, 2029 to Dec 31, 2035 · 10 morev3 Show 13 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment increased: 500 → 1000 participants
    • Completion pushed from Dec 31, 2029 to Dec 31, 2035
    • Trial arms changed: 2 → 1
    • Start date: Jan 1, 2024 to Jan 10, 2024
    • Interventions: Multimodal Cardiovascular Phenotyping (Diagnostic Test)
    • Eligibility criteria expanded, about 198 words
    • Secondary endpoints: 1 to 14
    • Study description expanded, about 454 words
    • Site contact updated
    • Collaborators: 4 to 3
    • Publications: 35 to 34
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  2. Primary endpoints: 6 to 10 Secondary endpoints: 6 to 1 · Study description shortened, about 932 words · Site contact updatedv2 Show 3 more changesShow less
    • Secondary endpoints: 6 to 1
    • Study description shortened, about 932 words
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of the GlycOxiTOD observational registry is to improve the early detection and characterization of vascular and other target-organ damage in adults at increased cardiovascular risk. Target-organ damage (TOD) means changes in the arteries, heart, kidneys, or other organs that may develop before cardiovascular symptoms or events occur. The registry studies how blood pressure, arterial function, vascular imaging, metabolic and glycoxidative markers, and non-invasive optical signals are related to this early damage. The main questions are: * Which clinical, blood pressure, imaging, and laboratory markers are associated with vascular and other target-organ damage? * Can photoplethysmography, a non-invasive optical technique that records changes in blood flow, identify abnormal arterial features? * Are new devices, measurement procedures, and signal-analysis methods technically valid, reliable, and reproducible when compared with established clinical methods? * Can combinations of clinical, imaging, laboratory, and device-derived measurements improve cardiovascular risk assessment? * How do vascular abnormalities and target-organ damage change during follow-up? Researchers will not assign any treatment as part of this observational registry. Participants will receive assessments that may include: * Clinical and cardiovascular risk evaluation * Office and 24-hour ambulatory blood pressure measurements * Blood and urine tests for metabolic, glycation, oxidative stress, and inflammatory markers * Non-invasive vascular ultrasound and arterial function measurements * Optical photoplethysmography recordings from peripheral or cervical arterial sites * Skin measurement of advanced glycation end products * Retinal imaging, when available * Repeated measurements to assess the reliability and reproducibility of selected devices and procedures * Follow-up using clinical visits and medical records to identify changes in target-organ damage and cardiovascular events The registry provides a shared clinical research platform for studies on hypertension, vascular imaging, arterial biomechanics, biomarkers, optical technologies, and the technical and methodological validation of non-invasive cardiovascular devices. Its overall aim is to support the development of reliable tools for early cardiovascular risk assessment and prevention.
Trial Details
NCT Number NCT06325800
Lead Sponsor Complejo Hospitalario Universitario de Santiago
Collaborators: Sociedad Española De Medicina Interna, Axencia Galega de Innovación (GAIN), Instituto de Investigación Sanitaria de Santiago de Compostela (IDIS)
Conditions Hypertension, Target Organ Damage, Heart Disease Risk Factors, Vascular Stiffness, Atherosclerosis
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov