Prediction Models for Cardiovascular and Neurocognitive Disease Risk in the General Population

NCT05951764 | Recruiting

• 2 other identifiers: APHP2303402022-A02829-34
• Study Type: observational
• Target: 396
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, Local; Anesthesia

Keywords

Predictive medicine; Cardiovascular biomarkers; Neurocognitive Biomarkers

Outcome Measures

Primary Outcomes (17)

• 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.

  Day 1

• 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.

  Day 1

• 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.

  Day 1

• 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.

  Day 1

• Non-invasive measurement of arterial stiffness by pulse wave velocity (PWV in m/s)

  For all patients, to enact 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.

  34 days

• Non-invasive measurement of systolic pulsatility index (SPI in %).

  For all patients, to light on 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.

  34 days

• Continuous non-invasive measurement of mean arterial pressure (MAP in mmHg)

  For all patients, to found 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.

  Day 1

• Discontinuous measurement of Systolic and Diastolic blood pressure by an oscillometric brachial blood pressure monitor (in mmHg)

  For all patients, to develop 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.

  Day 1

• Continuous electrocardiogram recording

  For all patients, to provide 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.

  Day 1

• Continuous digital photoplethysmography (PPG) recording (SpO2 in %)

  For all patients, to hinge 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.

  Day 1

• Delivered doses of hypnotics, morphine and paralytic agents

  For all patients, to constitute 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.

  Day 1

• To unearth 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.

  Psychometric scale with the MemScreen.

  5 years

• To unearth 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.

  Psychometric testing with the MoCA (Montreal Cognitive assessment). The scale is rated out of 30.

  5 years

• To find 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.

  Psychometric testing with the Motor function by the FTT (Finger Taping Test).

  5 years

• To uncover 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.

  Psychometric testing with the Lawton dependency scale with 4 items. The test is rated out of 4.

  5 years

• To reveal 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.

  Research of postoperative delirium by the CAM (Confusion Assessment Method) scale. The diagnosis of delirium requires the presence of 3 of the 4 criteria.

  2 days

• To establish a relationship between the values of pulse wave velocity and burst suppression, 95% spectral frequency front recorded during anesthesia and at 5 years with the occurrence of fatal and non-fatal cardiovascular complications

  With the measurement of occurrence of fatal (all-cause cardiovascular mortality at 2 years and up to 5 years) and non-fatal cardiovascular complications (myocardial infarction, stroke)

  5 years

Secondary Outcomes (1)

• To establish the association between biomarker values and radiological (brain imaging) and biological cardiac biomarkers.

  5 years

Interventions

Non-invasive measurement of arterial stiffness by Pulse Wave Velocity (PWV) DIAGNOSTIC_TEST

For all patients PWV in (cm/s) will be collected from D-30 to D-1 before the procedure and at D3 postoperatively.

Also known as: Measurement of arterial stiffness by pulse wave velocity (PWV, m/s) calculation by MESI mTablet (MESI ltd, Slovenia)., Non-invasive measurement of systolic pulsatility index (SPI in %) by MESI mTablet (MESI ltd, Slovenia).

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants or populations are selected based on predefined criteria

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• INSERM UMR-942, Paris, France: collaborator
• M3DISIM: collaborator

Study Sites (1)

AP-HP, Lariboisière Hospital, Department of Anesthesiology and Intensive Care

Paris, 75010, France

RECRUITING

MeSH Terms

Interventions

Pulse Wave Analysis

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Joaquim MATEO, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Joaquim MATEO, MD

CONTACT

149958374; joaquim.mateo@aphp.fr

Fabrice VALLEE, MD, PhD

CONTACT

149958071; fabrice.vallee@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: July 19, 2023
• Study Start: May 1, 2024
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2032
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

FR (1)