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A Monocentric Study Assessing the Efficacy of the Nitrosylated Hemoglobin as Biomarker for Detecting the Development of a Cardiovascular Complication During or After Surgery (PICA)

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ClinicalTrials.gov Identifier: NCT03994900
Recruitment Status : Not yet recruiting
First Posted : June 21, 2019
Last Update Posted : June 21, 2019
Sponsor:
Collaborator:
Nancy Van Overstraeten
Information provided by (Responsible Party):
Jean-Luc Balligand, Université Catholique de Louvain

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Complications Diagnostic Test: Blood sampling for HbNO assessment Early Phase 1

Detailed Description:

Cardiovascular diseases are the first mortality cause in Occidental countries. They would be the cause of 31% of the overall mortality in those countries.

Some risk factors are strongly related to the apparition of a cardiovascular disease, including smoking, high cholesterol levels, hypertension, diabetes, age, high BMI or familial early cardiovascular disease and/or hypercholesterolemia.

Multiple studies have already shown that major non-cardiac surgery can lead to cardiovascular complications in 3% of the patients regardless of their cardiovascular risk profile and major adverse cardiovascular events are a significant source of post-operative morbidity in approximately 11% among those patient3,4,6,7. Complications can also lead to a prolongated hospitalization for patients undergoing major non-cardiac surgery8,9.The peri- and post-operative cardiovascular complications depend on patient-related risk factors.

Surgery and anesthesia can provoke hemodynamic instability and stimulation of the sympathetic nervous system. Surgery and the ensuing inflammation can also induce bleeding and or thrombosis. These factors as top of some post-operative factors such as tissular hypoxemia, can result in cardiovascular complications.

An assessment of the medical cardiac history of the patients is performed before any surgery3. Developing a tool to predict post-operative cardiovascular complication could influence peri-operative measures by stratifying the population at risk.

It is known that cardiovascular diseases are preceded by a dysfunction of the vascular endothelium leading to a loss of the antithrombogenic, anti-proliferative and vasorelaxant functions.

A key mediator of vascular homeostasis and endothelial integrity is the nitric oxide (NO) produced by the endothelial NO synthetase (eNOS). 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.

Quantifying the HbNO could predict, prior to any major non-cardiac surgery, an eventual peri-operative cardiovascular complication. Preoperative HbNO would as such be a useful marker of cardiovascular complications. Necessary perioperative measures can therefore be taken in order to decrease this risk. This assessment would be associated to the preoperative anesthesia visit (EPI : évaluation péri-interventionnelle) form reporting previous cardiovascular events and risk factors.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Monocentric Study Assessing the Efficacy of the Nitrosylated Hemoglobin as Biomarker for Detecting the Development of a Cardiovascular Complication During or After Surgery
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : March 1, 2021

Arm Intervention/treatment
Experimental: Blood sampling for HbNO assessment Diagnostic Test: Blood sampling for HbNO assessment
Blood sampling




Primary Outcome Measures :
  1. Incidence of intra and postoperative cardiovascular complication or degradation within 12 months [ Time Frame: 12 months ]
    Incidence of intra and postoperative cardiovascular complication or degradation within 12 months

  2. the duration of hospitalization [ Time Frame: 12 months ]
    the duration of hospitalization

  3. the duration of residence in intensive care [ Time Frame: 12 months ]
    the duration of residence in intensive care

  4. the need for a follow-up by a cardiologist [ Time Frame: 12 months ]
    the need for a follow-up by a cardiologist


Secondary Outcome Measures :
  1. Incidence of a non-cardiovascular complication [ Time Frame: 12 months ]
    Incidence of a non-cardiovascular complication

  2. the LEE score at first visit [ Time Frame: 12 months ]
    the LEE score at first visit



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994900


Contacts
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Contact: Nancy Van Overstraeten, PhD Ir 027645288 nancy.vanoverstraeten@uclouvain.be

Locations
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Belgium
Cliniques Universitaires St Luc Not yet recruiting
Brussels, Belgium, 1200
Contact: Nancy Van Overstraeten, PhD Ir    027645288    nancy.vanoverstraeten@uclouvain.be   
Principal Investigator: Jean-Luc Balligand, Prof MD         
Sub-Investigator: Marie-Agnès Docquier, MD         
Sub-Investigator: Mona Momeni, MD         
Sponsors and Collaborators
Université Catholique de Louvain
Nancy Van Overstraeten

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Responsible Party: Jean-Luc Balligand, Professor MD, Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03994900     History of Changes
Other Study ID Numbers: PICA V2.2
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jean-Luc Balligand, Université Catholique de Louvain:
cardiovascular nitric oxide erythrocyte