NCT05951764 Prediction Models for Cardiovascular and Neurocognitive Disease Risk in the General Population
| NCT ID | NCT05951764 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Anesthesia, Local |
| Study Type | OBSERVATIONAL |
| Enrollment | 396 participants |
| Start Date | 2024-05 |
| Primary Completion | 2029-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 396 participants in total. It began in 2024-05 with a primary completion date of 2029-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
More accurate and earlier identification of people at risk of cardiovascular disease (CVD) and neurodegenerative diseases (memory, cognition, dementia) through the appropriate use of biomarkers could lead to earlier initiation of preventive therapies and potentially avoid sometimes fatal events and complications. Biomarkers are useful for determining the risk of disease, but also for establishing a diagnosis. High inter-individual variability hinders the establishment of general laws that can be- used in predictive medicine. In addition to the lack of validation, other limitations are the low participation rate in screening campaigns (regardless of disease) and the relative difficulty, accuracy, cost and time taken to perform the measurements. The perioperative period is a very good time to screen for cardiovascular and neurodegenerative pathologies for several reasons: * Patients come to their anesthesia consultation and to the operating room because they have a direct visible benefit. * the physiological data collected intraoperatively during systematic monitoring are very "rich" and of very good quality because they are not very noisy * The induction of general anesthesia or the onset of locoregional anesthesia and its maintenance represents a strong and reproducible physiological "test" for the cardiovascular and cerebral systems. * The patients are regularly re-examined postoperatively for the follow-up of their pathology and the possible complications are recorded in their file, allowing a short and medium term follow-up. The project aims to validate a biomarker predictive of cardiovascular complications, the pulse wave velocity, and a biomarker predictive of cognitive disorders, the power of the Alpha wave on the electroencephalogram, from the data usually collected during each anesthesia and during the perioperative period. The objective is to build a predictive model of cardiovascular and neurodegenerative risks, possibly combined, on a survival analysis.
Eligibility Criteria
Inclusion Criteria: * Patients \> 45 years old * Eligible for outpatient or scheduled surgery or interventional procedures under general anesthesia or locoregional anesthesia with sedation. * Patient having expressed no objection to participation in this research. * Patient who is not subject to a legal protection measure Exclusion Criteria: * Patients under 45 years of age. * Patient opposed to participation in the protocol * Pregnant woman * Patient under judicial protection * Patient not affiliated to a social health system
Contact & Investigator
Joaquim MATEO, MD
STUDY DIRECTOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT05951764 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, studying Anesthesia, Local. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05951764 currently recruiting?
Yes, NCT05951764 is actively recruiting participants. Contact the research team at joaquim.mateo@aphp.fr for enrollment information.
Where is the NCT05951764 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT05951764 clinical trial?
NCT05951764 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Joaquim MATEO, MD at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 396 participants.