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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,000
- Locations
- 2
- Primary Endpoint
- Assessment of redox status (1)
Study Overview
Brief 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.
Detailed Description
BACKGROUND AND PURPOSE
GlycOxiTOD is an ambispective observational registry designed to characterize vascular and other target-organ damage in adults evaluated for increased cardiovascular risk. The registry is coordinated at the Complejo Hospitalario Universitario de Santiago de Compostela and is designed to support collaborative and multicenter studies conducted under the corresponding ethical and institutional approvals.
The registry was initially developed to study the relationship between glycation, oxidative stress, arterial biomechanics, and target-organ damage. Its scope has subsequently expanded to provide a common clinical research platform integrating hemodynamic assessment, vascular imaging, biochemical markers, optical signals, and the technical and methodological evaluation of non-invasive cardiovascular devices.
The registry does not assign treatments or alter usual clinical care. Clinical decisions remain under the responsibility of the treating health care team.
SCIENTIFIC FRAMEWORK
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: Multimodal Cardiovascular Phenotyping (Diagnostic Test)
Outcomes
Primary Outcomes
Assessment of redox status (1)
Time Frame: Present, two, four years and final (5 years)
Evaluation of thiobarbituric acid reactive substances (TBARS) levels as a measure of lipid peroxidation
Assessment of redox status (2)
Time Frame: Present, two, four years and final (5 years)
Evaluation of reduced thiol levels as a measure of protein oxidation
Evaluation of glycation status (1)
Time Frame: Present, two, four years and final (5 years)
Measurement of serum fructosamine and glucose levels
Assessment of Glycoxidation status (1)
Time Frame: Present, two, four years and final (5 years)
Levels of thiobarbituric acid reactive substances (TBARS) also as an estimation of dicarbonyl levels from glycoxidation
Evaluation of glycation status (2)
Time Frame: Present, two, four years and final (5 years)
Measurement of the percentage of serum glycated hemoglobin
Evaluation of glycation status (3)
Time Frame: Present, two, four years and final (5 years)
Estimation of the percentage of serum glycated albumin
Evaluation of glycation status (4)
Time Frame: Present, two, four years and final (5 years)
Quantification of skin advanced glycation end products (AGEs)
Assessment of Glycoxidation status (2)
Time Frame: Present, two, four years and final (5 years)
Quantification of skin advanced glycation end products (AGEs) also as an estimation of the levels of some glycoxidation byproducts
Quantification of arterial targen organ damage (TOD) during the follow-up (1)
Time Frame: Present, two, four years and final (5 years)
Number of patients and severity (Arterial TOD considered as carotid intima-media thickness \>0.9 mm, cholesterol plaque, carotid stenosis, carotid-femoral pulse wave velocity \>10 m/s, pulse pressure \>60 mmHg, ankle-Brachial Index \<0.9 or \>1.3 hypertensive retinopathy)
Quantification of arterial targen organ damage (TOD) during the follow-up (2)
Time Frame: two, four years and final (5 years)
Number needed to treat (NNT) of consultations and exploration time to detect abnormalities in arterial biomechanics and target organ damage (TOD)
Presence of Baseline Vascular Target-Organ Damage or Subclinical Vascular Disease
Time Frame: At the baseline vascular assessment
Number and proportion of participants with baseline vascular target-organ damage or subclinical vascular disease, defined by at least one of the following: carotid plaque according to Mannheim criteria; femoral plaque according to prespecified ultrasound criteria; mean carotid intima-media thickness of 0.9 mm or greater; carotid-femoral pulse wave velocity greater than 10 m/s, or validated brachial-ankle pulse wave velocity greater than 14 m/s; or resting ankle-brachial index of 0.90 or lower. An ankle-brachial index greater than 1.40 is non-compressible. Components are recorded separately. Photoplethysmography-derived measures, investigational image-texture features, and device-estimated pulse wave velocity are excluded from the reference outcome. A participant is positive if any criterion is met; negative only when carotid/femoral imaging, validated pulse wave velocity, and ankle-brachial index are all evaluable and below threshold; otherwise indeterminate.
Secondary Outcomes
- Evaluation of cardiovascular disease during the follow-up(two, four years and final (5 years))
- Vascular Target-Organ Damage Burden(At the baseline vascular assessment)
- Presence of Renal Target-Organ Damage(At the baseline laboratory assessment)
- Presence of Cardiac Target-Organ Damage(At the baseline cardiovascular assessment)
- Presence of Retinal Target-Organ Damage(At the baseline retinal assessment)
- Presence of Other Target-Organ Damage(At the baseline registry assessment)
- Overall Target-Organ Damage Burden(At the baseline registry assessment)
- Association Between Ambulatory Blood Pressure Phenotypes and Target-Organ Damage(At the baseline ambulatory blood pressure and target-organ assessment)
- Association Between Glycation Markers and Vascular Target-Organ Damage(At the baseline laboratory, skin glycation, and vascular assessment)
- Association Between Glycoxidative and Redox Markers and Vascular Target-Organ Damage(At the baseline laboratory and vascular assessment)
- Proportion of Technically Valid Photoplethysmography Recordings(During the initial photoplethysmography assessment)
- Diagnostic Performance of Photoplethysmography for Vascular Target-Organ Damage(At the baseline photoplethysmography and vascular assessment)
- Technical Validity and Reproducibility of Non-Invasive Cardiovascular Devices(During the device-specific assessment, from the first measurement through completion of prespecified repeat measurements)
- Progression of Vascular Target-Organ Damage(Baseline and 5 years after enrollment)
- Time to First Major Cardiovascular Event(From enrollment through 5 years of follow-up)
Investigators
Nestor Vazquez Agra
Principal Investigator
Complejo Hospitalario Universitario de Santiago