Prediction Models for Cardiovascular and Neurocognitive Disease Risk in the General Population
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients under 45 years of age.
Patient opposed to participation in the protocol
Pregnant woman
Patient under judicial protection
Trial population
Participants or populations are selected based on predefined criteria
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Non-invasive measurement of arterial stiffness by Pulse Wave Velocity (PWV)
Diagnostic testFor all patients PWV in (cm/s) will be collected from D-30 to D-1 before the procedure and at D3 postoperatively.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Continuous measurement of burst suppression (in percent).
For all patients, to establish a relationship between the values of pulse wave velocity and burst suppression, 95% spectral frequency front recorded during anesthesia with the occurrence of a major neurocognitive event defined by delirium.
Time frame
Day 12
Continuous measurement of alpha band power (in dB).
For all patients, to authorize a relationship between the values of pulse wave velocity and burst suppression, 95% spectral frequency front recorded during anesthesia with the occurrence of a major neurocognitive event defined by delirium.
Time frame
Day 13
Continuous measurement of 95% spectral frequency front (SEF95) on Sedlin frontal EEG.
For all patients, to base a relationship between the values of pulse wave velocity and burst suppression, 95% spectral frequency front recorded during anesthesia with the occurrence of a major neurocognitive event defined by delirium.
Time frame
Day 14
Assessement of the depth of anesthesia (thanks to Patient State Index (PSI)) by coutinuous frontal EEG recording by Sedline.
For all patients, To create a relationship between the values of pulse wave velocity and burst suppression, 95% spectral frequency front recorded during anesthesia with the occurrence of a major neurocognitive event defined by delirium.
Time frame
Day 1Secondary outcomes
1
To establish the association between biomarker values and radiological (brain imaging) and biological cardiac biomarkers.
Parameters extracted from examinations performed as part of routine care during the 5 years of follow-up. Request to the APHP Health Data Hub (ORBIS for APHP) and contact with the attending physician
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Assistance Publique - Hôpitaux de Paris
Lead sponsor
INSERM UMR-942, Paris, France
Collaborator
M3DISIM
Collaborator
Source ClinicalTrials.gov