NCT03994900

Brief Summary

Cardiovascular diseases are the first mortality cause in Occidental countries. Surgery and anesthesia can provoke hemodynamic instability and stimulation of the sympathetic nervous system as well as bleeding or thrombosis. These factors as top of some post-operative factors such as tissular hypoxemia, can result in cardiovascular complications. Developing a tool to predict post-operative cardiovascular complication could influence peri-operative measures by stratifying the population at risk. UCLouvain has developed a patented technique using a paramagnetic electronic resonance spectrometry (EPR) able to quantify a paramagnetic component, nitrosylated hemoglobin (HbNO) of the erythrocytes drawn from venous blood. This HbNO has been correlated to the traditional cardiac risk factors. In this study, we will assess the HbNO of patients prior to surgery and will correlate it with cardiovascualr and non cardiovascular complications in order to evaluate the predictive aspect of our biomarker.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

November 21, 2022

Status Verified

November 1, 2022

Enrollment Period

3.7 years

First QC Date

June 19, 2019

Last Update Submit

November 16, 2022

Conditions

Cardiovascular Complications

Keywords

cardiovascular nitric oxide erythrocyte

Outcome Measures

Primary Outcomes (4)

  • Incidence of intra and postoperative cardiovascular complication or degradation within 12 months

    Incidence of intra and postoperative cardiovascular complication or degradation within 12 months

    12 months

  • the duration of hospitalization

    the duration of hospitalization

    12 months

  • the duration of residence in intensive care

    the duration of residence in intensive care

    12 months

  • the need for a follow-up by a cardiologist

    the need for a follow-up by a cardiologist

    12 months

Secondary Outcomes (2)

  • Incidence of a non-cardiovascular complication

    12 months

  • the LEE score at first visit

    12 months

Study Arms (1)

Blood sampling for HbNO assessment

EXPERIMENTAL
Diagnostic Test: Blood sampling for HbNO assessment

Interventions

Blood sampling for HbNO assessmentDIAGNOSTIC_TEST

Blood sampling

Blood sampling for HbNO assessment

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 100 years
  • Written informed consent
  • For subjects unable to read and/or write, oral informed consent observed by an independent witness is acceptable if the subject has fully understood oral information given by the Investigator. The witness should sign the consent form on behalf of the subject.
  • Forthcoming major surgery + one of the following:
  • At least one risk factor for cardiovascular disease:
  • SCORE \> 1% and \< 5% BMI \> 30 Age \> 55 years BP: \>130 SBP and/or \>85 DBP Diabetes type 1 or 2 Active smoker regardless of age Shorteness of breath after climbing 20 stairs Familial early CV disease (\<50 years for men; \<55 years for women) Familial hypercholesterolemia (segregation of hypercholesterolemic trait or proven genetic mutation at heterozygous or homozygous state)
  • LEE score \>2
  • Thrombophilia: Factor V Leiden
  • Flap surgery
  • Surgery for liver or kidney graft
  • Known cause (i.e. COPD) of respiratory dysfunction; patients under positive pressure (CPAP) treatment
  • Sleep apnea syndrome
  • Pregnant women at risk of pre-eclampsia: \> 20 weeks of pregnancy and one of the following:
  • SBP \> 160 mmHg DBP \> 110 mmHg Rise of SBP \> 30 mmHg compared to baseline value Rise of DBP \> 10 mmHg compared to baseline value Proteinuria ≥ 30 mg/L
  • o Pre-operative creatinine \> 130 µmol/L (\> 1.5 mg/dL)

You may not qualify if:

  • Patients undergoing a cardiovascular surgery
  • Patients unable to give informed consent (people under legal guardianship)
  • Patients placed in an institution by official or court order

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires St Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor MD

Study Record Dates

First Submitted

June 19, 2019

First Posted

June 21, 2019

Study Start

October 1, 2019

Primary Completion

June 30, 2023

Study Completion

September 1, 2023

Last Updated

November 21, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)