Lipid Management Gaps in Mexican Patients at High and Very High Cardiovascular Risk (SANTORINI-MX)
SANTORINI-MX: Lipid Management Gaps in Mexican Patients at High and Very High Cardiovascular Risk
SANTORINI-MX is a nationwide, multicenter, prospective, observational study designed to evaluate cholesterol management among adults in Mexico who are at high or very high risk of cardiovascular disease.
The main objective is to determine the proportion of patients who achieve the recommended low-density lipoprotein cholesterol (LDL-C) goals according to the 2019 European Society of Cardiology/European Atherosclerosis Society guidelines.
Approximately 1,600 adults will be enrolled from an initial network of 15 public and private healthcare centers across Mexico. Participants will be evaluated at enrollment and followed for approximately 12 months, with an allowable follow-up window of 10 to 14 months.
The study will collect information on cholesterol levels, cardiovascular risk factors, lipid-lowering medications, treatment changes, medication adherence, and barriers to optimal cholesterol management. Researchers will also examine whether treatment is intensified when LDL-C goals are not achieved.
This is a non-interventional study. Medical treatments and decisions will remain under the responsibility of each participant's treating physician, and no additional medical procedures will be required solely for research purposes.
The findings are expected to help identify gaps in cholesterol management in Mexico and inform future strategies to improve cardiovascular prevention and patient care.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Background and Rationale
Atherosclerotic cardiovascular disease (ASCVD) remains a major cause of morbidity and mortality in Mexico. Lowering low-density lipoprotein cholesterol (LDL-C) is a fundamental strategy for reducing cardiovascular risk. Despite the availability of effective lipid-lowering therapies, substantial gaps persist between guideline-recommended LDL-C targets and lipid management in routine clinical practice.
International observational studies, including DA VINCI and SANTORINI, have documented limited achievement of LDL-C goals and underutilization of combination lipid-lowering therapies. However, contemporary standardized data describing lipid management practices, treatment intensification, and barriers to optimal lipid control remain limited in Mexico.
SANTORINI-MX aims to address these knowledge gaps by establishing a nationwide observational registry of adults at high and very high cardiovascular risk.
Study Design and Population
SANTORINI-MX is a multicenter, prospective, observational, non-interventional patient registry coordinated by the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ), with academic support from the Sociedad Mexicana de Nutrición y Endocrinología (SMNE).
Approximately 1,600 participants will be consecutively enrolled from an initial network of 15 public and private healthcare centers across Mexico.
Eligible participants will be adults aged 18 years or older classified as having high or very high cardiovascular risk according to the 2019 European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) clinical risk categories. Participants must have an indication for lipid-lowering therapy or be receiving such treatment, have an available baseline LDL-C measurement, have an expected survival exceeding one year, and provide written informed consent.
The study will include both previously treated individuals and patients newly diagnosed or initiating lipid-lowering treatment.
Lipid Assessment and Treatment Goals
The primary objective is to estimate the proportion of participants achieving risk-based LDL-C targets according to the 2019 ESC/EAS guidelines:
- High cardiovascular risk: LDL-C below 70 mg/dL.
- Very high cardiovascular risk: LDL-C below 55 mg/dL.
An exploratory LDL-C target below 40 mg/dL will also be evaluated in participants with recurrent cardiovascular events within two years, when sufficient information is available.
Baseline lipid measurements obtained within the 12 months preceding enrollment will be accepted. Follow-up LDL-C measurements will be assessed at 12 ± 2 months, using the measurement closest to the target follow-up date when multiple results are available.
Lipid parameters will be standardized through centralized calculations, including LDL-C using the Sampson equation, non-HDL cholesterol, and remnant cholesterol.
Clinical and Therapeutic Data Collection
Data will be obtained from routine medical records and brief patient interviews. Information will include demographic characteristics, cardiovascular history, comorbidities, laboratory findings, lipid-lowering medication use, treatment intensity, medication adherence, statin intolerance, and barriers to treatment optimization.
Lipid-lowering therapies of interest include statins, ezetimibe, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, inclisiran, bempedoic acid, fibrates, and omega-3 fatty acids.
The study will evaluate treatment modifications during follow-up, including statin dose escalation, switching to more potent agents, combination therapy, and initiation of advanced lipid-lowering therapies.
Clinical inertia will be operationally defined as LDL-C above the recommended risk-based target without treatment intensification during follow-up. Reasons for the absence of intensification will be documented when available.
Barriers to treatment optimization will be classified at the patient, physician, and institutional levels, including medication cost, adherence difficulties, treatment availability, administrative requirements, and clinical decision-making.
Additional laboratory parameters, including apolipoprotein B, lipoprotein(a), glycated hemoglobin, kidney function markers, and inflammatory biomarkers, will be assessed when available in routine care.
Patient-reported outcomes, including health-related quality of life using EQ-5D-5L and patient activation using PAM-13, will be assessed when feasible. Cardiovascular events and healthcare resource utilization will be recorded as exploratory outcomes.
Follow-up and Data Management
Participants will undergo baseline assessment and follow-up at 12 ± 2 months. Follow-up information will be obtained through routine medical records and, when necessary and authorized by participants, direct telephone contact.
No additional medical procedures or protocol-assigned treatments will be required. All clinical decisions will remain at the discretion of the treating physicians.
Study data will be entered into a centralized, institutionally hosted REDCap database. Standardized electronic case report forms, automated validation rules, investigator training, and centralized data quality monitoring will be implemented.
Statistical Analysis
The primary analysis will estimate the proportion of participants achieving LDL-C targets, with corresponding 95% confidence intervals.
Descriptive analyses will summarize clinical characteristics, lipid profiles, treatment patterns, and goal attainment. Continuous variables will be reported using means and standard deviations or medians and interquartile ranges, as appropriate. Categorical variables will be presented as frequencies and percentages.
Prespecified subgroup analyses will consider cardiovascular risk category, established ASCVD, diabetes mellitus, chronic kidney disease, menopausal status, healthcare sector, and treating physician specialty.
Exploratory multivariable models will assess factors associated with failure to achieve LDL-C targets and clinical inertia. Missing data will be reported transparently, and sensitivity analyses will be performed when appropriate.
Expected Contribution
SANTORINI-MX will provide contemporary evidence on lipid management gaps among Mexican patients at high and very high cardiovascular risk. Its findings are intended to support improved clinical practice, professional education, and future implementation strategies aimed at optimizing cardiovascular prevention.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Daniel B Elías López, PhD
- Telefonní číslo: +52 5528987888
- E-mail: daniel.eliasl@incmnsz.mx
Studijní záloha kontaktů
- Jméno: Carlos A Aguilar Salinas, PhD
- Telefonní číslo: +52 5535010502
- E-mail: carlos.aguilars@incmnsz.mx
Studijní místa
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Mexico City
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Mexico City, Mexico City, Mexiko, 14080
- Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
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Kontakt:
- Carlos A Aguilar Salinas, PhD
- Telefonní číslo: +52 5535010502
- E-mail: carlos.aguilars@incmnsz.mx
-
Kontakt:
- Daniel B Elias Lopez, PhD
- Telefonní číslo: +52 5528987888
- E-mail: daniel.eliasl@incmnsz.mx
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
The study population will consist of adults aged 18 years or older classified as having high or very high cardiovascular risk according to the 2019 ESC/EAS clinical risk categories. Eligible participants will be receiving or have a clinical indication for lipid-lowering therapy and will be recruited consecutively from an initial network of approximately 15 public and private healthcare centers across Mexico. Participants may have established atherosclerotic cardiovascular disease, diabetes mellitus, chronic kidney disease, familial hypercholesterolemia, or other clinical conditions associated with elevated cardiovascular risk. Both previously treated and newly treated patients will be eligible.
Popis
Inclusion Criteria:
- Adults aged 18 years or older.
- Patients classified as having high or very high cardiovascular risk by their treating physician according to the 2019 European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) clinical risk categories.
- Patients currently receiving lipid-lowering therapy or with a clinical indication for lipid-lowering treatment.
- Availability of a baseline low-density lipoprotein cholesterol (LDL-C) measurement, either directly reported or calculable from a lipid profile obtained within the 12 months preceding enrollment.
- Life expectancy greater than one year, based on the treating physician's clinical judgment.
- Provision of written informed consent.
Exclusion Criteria:
- No formal exclusion criteria are established in the study protocol.
- Participants for whom critical baseline variables, particularly an LDL-C measurement with its corresponding date, cannot be documented will not be eligible for the primary analysis dataset.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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High and Very High Cardiovascular Risk Patients
Adults aged 18 years or older classified as having high or very high cardiovascular risk according to the 2019 ESC/EAS guidelines, who are receiving or have a clinical indication for lipid-lowering therapy. Participants will be consecutively enrolled at participating healthcare centers in Mexico and assessed at baseline and after 12 ± 2 months. Lipid levels, cardiovascular risk factors, lipid-lowering treatments, treatment intensification, medication adherence, and barriers to optimal lipid management will be recorded. All treatments will be prescribed according to routine clinical practice, without protocol-assigned interventions. |
Lipid-lowering medications prescribed as part of routine clinical care, including statins, ezetimibe, PCSK9 inhibitors, inclisiran, bempedoic acid, fibrates, and omega-3 fatty acids. Medication class, dose, treatment intensity, combinations, and changes during follow-up will be documented. Treatment decisions will be made exclusively by the treating physicians. No medication will be assigned, administered, or modified by the study protocol. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Proportion of Participants Achieving Risk-Based LDL-C Treatment Goals
Časové okno: Baseline (at enrollment; LDL-C measurement obtained within the preceding 12 months)
|
The percentage of participants achieving low-density lipoprotein cholesterol (LDL-C) targets according to their cardiovascular risk category, as defined by the 2019 ESC/EAS guidelines: LDL-C below 70 mg/dL for high-risk participants and below 55 mg/dL for very-high-risk participants. The numerator will be the number of participants achieving their corresponding risk-based LDL-C target, and the denominator will be the number of evaluable participants with baseline LDL-C data. Results will be reported overall and stratified by cardiovascular risk category, with 95% confidence intervals. |
Baseline (at enrollment; LDL-C measurement obtained within the preceding 12 months)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Proportion of Participants Achieving Risk-Based LDL-C Goals at 12 Months
Časové okno: 12 months after enrollment (±2 months)
|
Percentage of participants achieving their cardiovascular risk-based LDL-C goals at follow-up, defined according to the 2019 ESC/EAS guidelines as LDL-C below 70 mg/dL for high-risk patients and below 55 mg/dL for very-high-risk patients. The numerator will include participants achieving their respective LDL-C target, and the denominator will include participants with an evaluable follow-up LDL-C measurement. Results will be reported overall and stratified by cardiovascular risk category, with 95% confidence intervals. |
12 months after enrollment (±2 months)
|
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Lipid-Lowering Treatment Patterns at Baseline and Follow-up
Časové okno: Baseline and 12 months (±2 months)
|
Number and percentage of participants receiving each lipid-lowering therapy class, including statins, ezetimibe, PCSK9 inhibitors, inclisiran, bempedoic acid, fibrates, and omega-3 fatty acids. Statin intensity (low, moderate, or high) and use of combination therapies will be described at baseline and follow-up. |
Baseline and 12 months (±2 months)
|
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Proportion of Participants With Lipid-Lowering Treatment Intensification
Časové okno: From enrollment to 12 months (±2 months)
|
Percentage of participants undergoing lipid-lowering treatment intensification during follow-up, defined as an increase in statin intensity, addition of another lipid-lowering agent, initiation of advanced lipid-lowering therapy, or escalation to combination treatment. Types and reasons for intensification will be described. |
From enrollment to 12 months (±2 months)
|
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Proportion of Participants With Clinical Inertia in Lipid-Lowering Treatment
Časové okno: From enrollment through 12 months (±2 months)
|
Clinical inertia will be assessed as a single binary outcome (yes/no) among participants with LDL-C levels above their cardiovascular risk-based treatment targets according to the 2019 ESC/EAS guidelines. It will be defined as the absence of lipid-lowering treatment intensification during follow-up. Treatment intensification includes an increase in statin intensity, initiation of ezetimibe, or initiation of advanced lipid-lowering therapy. These criteria will be combined to classify each participant as having or not having clinical inertia, rather than being reported separately. The outcome will be expressed as the percentage of evaluable participants with LDL-C above their treatment targets who do not undergo treatment intensification. The numerator will include participants with clinical inertia, and the denominator will include all evaluable participants with LDL-C above their corresponding targets. |
From enrollment through 12 months (±2 months)
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Changes in Lipid Parameters From Baseline to 12 Months
Časové okno: Baseline and 12 months after enrollment (±2 months)
|
Absolute changes from baseline to follow-up in low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), remnant cholesterol, and triglycerides, expressed in mg/dL. Apolipoprotein B (mg/dL) and lipoprotein(a) (mg/dL or nmol/L) will also be evaluated when available. LDL-C and remnant cholesterol will be calculated centrally using standardized methods, including the Sampson equation for LDL-C. Changes will be summarized overall and by cardiovascular risk category. |
Baseline and 12 months after enrollment (±2 months)
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Proportion of Participants With Barriers to Lipid-Lowering Treatment Optimization
Časové okno: Baseline and 12 months after enrollment (±2 months)
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Percentage of participants with at least one documented barrier to lipid-lowering treatment optimization, assessed through patient interviews and/or treating physician evaluation. Barriers will be classified as patient-related (medication cost, fear of adverse effects, forgetfulness, polypharmacy, and access difficulties), physician-related (perceived lack of need for treatment intensification, uncertainty regarding treatment targets, and limited consultation time), or institutional (medication unavailability, drug shortages, and administrative requirements). The numerator will include participants with at least one reported barrier, and the denominator will include participants with an evaluable barrier assessment. Individual barrier categories will be summarized descriptively. |
Baseline and 12 months after enrollment (±2 months)
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Proportion of Participants With High Medication Adherence
Časové okno: Baseline and 12 months after enrollment (±2 months)
|
Percentage of participants classified as having high adherence to prescribed lipid-lowering therapy, based on patient self-report and treating physician assessment. Adherence will be categorized as high, moderate, or low according to medication-taking behavior, missed doses, treatment discontinuation, and understanding of treatment instructions. The denominator will include participants with an evaluable adherence assessment. |
Baseline and 12 months after enrollment (±2 months)
|
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Proportion of Participants With Documented Statin Intolerance
Časové okno: Baseline and 12 months after enrollment (±2 months)
|
Statin intolerance will be evaluated as a single binary outcome (yes/no) using the study questionnaire and available clinical information. The assessment will consider previous exposure to at least two different statins, muscle-related symptoms or creatine kinase elevation, and available evidence of symptom improvement following statin discontinuation or recurrence after rechallenge. These clinical and laboratory findings will be used collectively to determine whether each participant meets the study definition of documented statin intolerance; they will not be reported as separate outcome measures under this endpoint. The outcome will be expressed as the percentage of evaluable participants classified as having documented statin intolerance. The numerator will be the number of participants meeting the study definition of statin intolerance, and the denominator will be the total number of participants with an evaluable statin intolerance assessment. |
Baseline and 12 months after enrollment (±2 months)
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Change in Glycated Hemoglobin (HbA1c) From Baseline to 12 Months
Časové okno: Baseline and 12 months after enrollment (±2 months)
|
Absolute change in glycated hemoglobin (HbA1c), expressed in percentage points, from baseline to 12 months. The change will be calculated as the 12-month value minus the baseline value. Analyses will include participants with available paired HbA1c measurements. This is a continuous laboratory measurement, not a scoring scale. |
Baseline and 12 months after enrollment (±2 months)
|
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Change in High-Sensitivity C-Reactive Protein From Baseline to 12 Months
Časové okno: Baseline and 12 months after enrollment (±2 months)
|
Absolute change in high-sensitivity C-reactive protein (hs-CRP), expressed in mg/L, from baseline to 12 months. The change will be calculated as the 12-month value minus the baseline value. Analyses will include participants with available paired hs-CRP measurements. This is a continuous laboratory measurement, not a scoring scale. |
Baseline and 12 months after enrollment (±2 months)
|
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Change in Serum Creatinine From Baseline to 12 Months
Časové okno: Baseline and 12 months after enrollment (±2 months)
|
Absolute change in serum creatinine concentration, expressed in mg/dL, from baseline to 12 months. The change will be calculated as the 12-month value minus the baseline value. Analyses will include participants with available paired serum creatinine measurements. This is a continuous laboratory measurement, not a scoring scale. |
Baseline and 12 months after enrollment (±2 months)
|
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Change in Health-Related Quality of Life Assessed by EQ-5D-5L
Časové okno: Baseline and 12 months after enrollment (±2 months)
|
Change in health-related quality of life assessed using the EQ-5D-5L questionnaire, including five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels, from no problems to extreme problems or inability to perform the activity. Responses will be analyzed at baseline and follow-up when questionnaires are available. |
Baseline and 12 months after enrollment (±2 months)
|
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Change in Patient Activation Measure (PAM-13) Score
Časové okno: Baseline and 12 months after enrollment (±2 months)
|
Change in patient activation from baseline to follow-up, assessed using the 13-item Patient Activation Measure (PAM-13). The instrument evaluates patients' knowledge, skills, and confidence in managing their health. Standardized activation scores range from 0 to 100, with higher scores indicating greater patient activation. Changes will be analyzed among participants with evaluable questionnaires at both time points. |
Baseline and 12 months after enrollment (±2 months)
|
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Change in Estimated Glomerular Filtration Rate From Baseline to 12 Months
Časové okno: Baseline and 12 months after enrollment (±2 months)
|
Absolute change in estimated glomerular filtration rate (eGFR), expressed in mL/min/1.73 m², from baseline to 12 months. The change will be calculated as the 12-month value minus the baseline value. Analyses will include participants with available paired eGFR measurements. This is a continuous renal function measurement, not a scoring scale. |
Baseline and 12 months after enrollment (±2 months)
|
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Change in Urinary Albumin-to-Creatinine Ratio From Baseline to 12 Months
Časové okno: Baseline and 12 months after enrollment (±2 months)
|
Absolute change in urinary albumin-to-creatinine ratio (UACR), expressed in mg/g, from baseline to 12 months. The change will be calculated as the 12-month value minus the baseline value. Analyses will include participants with available paired UACR measurements. This is a continuous laboratory measurement, not a scoring scale. |
Baseline and 12 months after enrollment (±2 months)
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Cardiovascular Events During Follow-up
Časové okno: From enrollment through 12 months (±2 months)
|
Number and proportion of participants with documented cardiovascular events during follow-up, based on available clinical records. Events will be summarized descriptively as exploratory outcomes. No formal hypothesis testing for cardiovascular event reduction is planned. |
From enrollment through 12 months (±2 months)
|
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Healthcare Resource Utilization During Follow-up
Časové okno: From enrollment through 12 months (±2 months)
|
Descriptive assessment of healthcare resource utilization during follow-up, based on available clinical records and patient-reported information when collected. The frequency and types of documented healthcare encounters will be summarized as exploratory outcomes. |
From enrollment through 12 months (±2 months)
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Daniel B Elias Lopez, PhD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Publikace a užitečné odkazy
Obecné publikace
- Ray KK, Molemans B, Schoonen WM, Giovas P, Bray S, Kiru G, Murphy J, Banach M, De Servi S, Gaita D, Gouni-Berthold I, Hovingh GK, Jozwiak JJ, Jukema JW, Kiss RG, Kownator S, Iversen HK, Maher V, Masana L, Parkhomenko A, Peeters A, Clifford P, Raslova K, Siostrzonek P, Romeo S, Tousoulis D, Vlachopoulos C, Vrablik M, Catapano AL, Poulter NR; DA VINCI study. EU-Wide Cross-Sectional Observational Study of Lipid-Modifying Therapy Use in Secondary and Primary Care: the DA VINCI study. Eur J Prev Cardiol. 2021 Sep 20;28(11):1279-1289. doi: 10.1093/eurjpc/zwaa047.
- Mach F, Baigent C, Catapano AL, Koskinas KC, Casula M, Badimon L, Chapman MJ, De Backer GG, Delgado V, Ference BA, Graham IM, Halliday A, Landmesser U, Mihaylova B, Pedersen TR, Riccardi G, Richter DJ, Sabatine MS, Taskinen MR, Tokgozoglu L, Wiklund O; ESC Scientific Document Group. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J. 2020 Jan 1;41(1):111-188. doi: 10.1093/eurheartj/ehz455. No abstract available.
- Ray KK, Haq I, Bilitou A, Manu MC, Burden A, Aguiar C, Arca M, Connolly DL, Eriksson M, Ferrieres J, Laufs U, Mostaza JM, Nanchen D, Rietzschel E, Strandberg T, Toplak H, Visseren FLJ, Catapano AL; SANTORINI Study Investigators. Treatment gaps in the implementation of LDL cholesterol control among high- and very high-risk patients in Europe between 2020 and 2021: the multinational observational SANTORINI study. Lancet Reg Health Eur. 2023 Apr 5;29:100624. doi: 10.1016/j.lanepe.2023.100624. eCollection 2023 Jun.
- Mach F, Koskinas KC, Roeters van Lennep JE, Tokgozoglu L, Badimon L, Baigent C, Benn M, Binder CJ, Catapano AL, De Backer GG, Delgado V, Fabin N, Ference BA, Graham IM, Landmesser U, Laufs U, Mihaylova B, Nordestgaard BG, Richter DJ, Sabatine MS; ESC/EAS Scientific Document Group. 2025 Focused Update of the 2019 ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2025 Nov 7;46(42):4359-4378. doi: 10.1093/eurheartj/ehaf190. No abstract available.
- Ray KK, Haq I, Bilitou A, Aguiar C, Arca M, Connolly DL, Eriksson M, Ferrieres J, Hildebrandt P, Laufs U, Mostaza JM, Nanchen D, Rietzschel E, Strandberg T, Toplak H, Visseren FLJ, Catapano AL. Evaluation of contemporary treatment of high- and very high-risk patients for the prevention of cardiovascular events in Europe - Methodology and rationale for the multinational observational SANTORINI study. Atheroscler Plus. 2021 Aug 13;43:24-30. doi: 10.1016/j.athplu.2021.08.003. eCollection 2021 Sep.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- DIA-5989-26-28-1
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
The individual participant data (IPD) sharing plan has not yet been determined. Study data will be collected and stored in a secure, institutionally managed REDCap database with restricted access and without direct personal identifiers. Any future sharing of de-identified participant-level data will require authorization from the study sponsor and relevant ethics committees, in accordance with applicable data protection regulations and institutional policies. Aggregate study findings are expected to be disseminated through scientific publications and presentations.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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