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Multimodal Vascular Phenotyping and Target-Organ Damage Using Vascular Imaging, Glyco-Oxidative Biomarkers, and Photoplethysmography in Adults at Increased Cardiovascular Risk: The GlycOxiTOD Observational Registry

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Complejo Hospitalario Universitario de Santiago de Compostela
RECRUITING
Santiago De Compostela
Contact Information
Primary
Nestor Vazquez-Agra, PhD
nestor.vazquez.agra@sergas.es
0034981951256
Time Frame
Start Date: 2024-01-10
Estimated Completion Date: 2035-12-31
Participants
Target number of participants: 1000
Treatments
GlycOxiTOD Registry Cohort
Adults enrolled in the GlycOxiTOD observational registry during evaluation for increased cardiovascular risk. The cohort includes participants undergoing cardiovascular risk assessment and evaluation of vascular or other target-organ damage. Participants may be followed through clinical visits and medical-record review to assess changes in cardiovascular risk factors, target-organ damage, treatments, health care use, and cardiovascular events. No treatment is assigned by the registry.
Related Therapeutic Areas
Sponsors
Collaborators: Axencia Galega de Innovación (GAIN), Sociedad Española De Medicina Interna, Instituto de Investigación Sanitaria de Santiago de Compostela (IDIS)
Leads: Complejo Hospitalario Universitario de Santiago

This content was sourced from clinicaltrials.gov