GlycOxiTOD: Multimodal Vascular and Target-Organ Damage Registry
Recruiting now
Conditions studied: Hypertension, Target Organ Damage, Heart Disease Risk Factors, Vascular Stiffness, Atherosclerosis
In brief
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.
Key facts
- Study ID
- NCT06325800
- Run by
- Complejo Hospitalario Universitario de Santiago
- People needed
- 1000
- Starts
- 2024-01-10
- Expected to finish
- 2035-12-31
- Last updated by the study team
- 2026-08-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 years or older.
- Written informed consent to participate in the registry.
- Undergoing cardiovascular risk or hypertension assessment in a primary-prevention setting.
- At least one of the following cardiovascular risk conditions:
- Confirmed hypertension requiring specialist cardiovascular assessment.
- A SCORE2 estimated 10-year cardiovascular risk of 2% or higher in participants aged 40 to 69 years, when SCORE2 is applicable.
- A SCORE2-OP estimated 10-year cardiovascular risk of 2% or higher in participants aged 70 to 89 years, when SCORE2-OP is applicable.
- Type 2 diabetes with at least moderate cardiovascular risk according to SCORE2-Diabetes in participants within its validated age range, or according to guideline-defined clinical risk criteria when SCORE2-Diabetes is not applicable.
- Chronic kidney disease confirmed for at least 3 months, defined by an estimated glomerular filtration rate below 60 mL/min/1.73 m², a urinary albumin-to-creatinine ratio of 30 mg/g or higher, or another persistent marker of kidney damage.
- Hypertension-mediated target-organ damage or subclinical atherosclerotic vascular disease documented by clinical, laboratory, imaging, or functional assessment.
- Confirmed or probable familial hypercholesterolemia.
- For participants aged 18 to 39 years or older than 89 years, a documented major cardiovascular risk condition, such as hypertension, type 2 diabetes, chronic kidney disease, familial hypercholesterolemia, or target-organ damage.
You may not qualify if…
- Inability or unwillingness to provide written informed consent.
- Established clinical cardiovascular disease requiring secondary-prevention management, including previous myocardial infarction, acute coronary syndrome, stroke, transient ischemic attack, coronary or peripheral revascularization, symptomatic peripheral artery disease, or other established symptomatic cardiovascular disease.
- Acute or clinically unstable illness that prevents completion of the baseline registry assessment.
- A medical, technical, cognitive, or logistical condition that prevents completion of the minimum required registry procedures.
Where it is running
- Complejo Hospitalario Universitario de Santiago de Compostela — Santiago de Compostela, A Coruña, Spain (enrolling)
Full record on ClinicalTrials.gov
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