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.
Age 18 years or older.
Written informed consent to participate in the registry.
Undergoing cardiovascular risk or hypertension assessment in a primary-prevention setting.
Confirmed hypertension requiring specialist cardiovascular assessment.
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.
Participants will be selected from adults evaluated in outpatient Internal Medicine, Hypertension, and Cardiovascular Risk clinics at the Complejo Hospitalario Universitario de Santiago de Compostela, A Coruña, Spain. The source population includes people referred from primary care or other hospital services for assessment of elevated blood pressure, hypertension, cardiovascular risk factors, suspected subclinical target-organ damage, or non-invasive vascular evaluation. Eligible participants are enrolled consecutively whenever possible. The registry reflects routine clinical practice and may include both newly evaluated participants and individuals previously characterized under the applicable protocol who have provided the required informed consent.
Cohort
Other
Multimodal Cardiovascular Phenotyping
Diagnostic testMultimodal cardiovascular phenotyping may include clinical and anthropometric assessment; office and 24-hour ambulatory blood pressure monitoring; vascular ultrasound and arterial-function measurements; blood and urine biomarkers related to metabolism, glycation, oxidative stress, and inflammation; skin advanced glycation assessment; retinal imaging; and peripheral or cervical photoplethysmography. Selected measurements may be repeated to assess technical feasibility, agreement with reference methods, repeatability, reproducibility, and signal or image quality of non-invasive devices and analytical procedures. Assessments depend on the applicable protocol or nested study, and not all participants undergo every procedure.
Presence of Baseline Vascular Target-Organ Damage or Subclinical Vascular Disease
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.
Vascular Target-Organ Damage Burden
Number of affected vascular domains among: structural atherosclerotic damage (carotid or femoral plaque, or mean carotid intima-media thickness of 0.9 mm or greater); large-artery stiffness (carotid-femoral pulse wave velocity greater than 10 m/s or validated brachial-ankle pulse wave velocity greater than 14 m/s); and lower-extremity arterial disease (ankle-brachial index of 0.90 or lower). The score ranges from 0 to 3. It is calculated only when all three domains are evaluable; otherwise, affected and evaluable domains are reported separately. An ankle-brachial index greater than 1.40 is classified as non-compressible and not normal.
Presence of Renal Target-Organ Damage
Number and proportion of participants with renal target-organ damage, 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 protocol-defined marker of kidney damage. Chronic kidney disease criteria require evidence of persistence when applicable. Participants without sufficient renal data are classified as indeterminate.
Presence of Cardiac Target-Organ Damage
Number and proportion of participants with cardiac target-organ damage according to prespecified electrocardiographic or echocardiographic criteria. The primary cardiac component is left ventricular hypertrophy, defined using protocol-specified sex-specific thresholds. Additional structural or functional cardiac abnormalities are recorded separately when available. Participants without an evaluable cardiac assessment are classified as indeterminate.
Presence of Retinal Target-Organ Damage
Number and proportion of participants with retinal target-organ damage based on retinal imaging, ophthalmologic examination, or validated clinical documentation. Hypertensive retinopathy and other prespecified retinal microvascular abnormalities are classified using the protocol-defined grading system. The denominator is limited to participants with an evaluable retinal assessment.
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Complejo Hospitalario Universitario de Santiago
Lead sponsor
Sociedad Española De Medicina Interna
Collaborator
Axencia Galega de Innovación (GAIN)
Collaborator
Instituto de Investigación Sanitaria de Santiago de Compostela (IDIS)
Collaborator
