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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

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03994900
Acronym
PICA
Enrollment
2500
Registered
2019-06-21
Start date
2019-10-01
Completion date
2023-09-01
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Complications

Keywords

cardiovascular nitric oxide erythrocyte

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.

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.

Interventions

DIAGNOSTIC_TESTBlood sampling for HbNO assessment

Blood sampling

Sponsors

SPINOVIT
CollaboratorUNKNOWN
Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the need for a follow-up by a cardiologist12 monthsthe need for a follow-up by a cardiologist
Incidence of intra and postoperative cardiovascular complication or degradation within 12 months12 monthsIncidence of intra and postoperative cardiovascular complication or degradation within 12 months
the duration of hospitalization12 monthsthe duration of hospitalization
the duration of residence in intensive care12 monthsthe duration of residence in intensive care

Secondary

MeasureTime frameDescription
Incidence of a non-cardiovascular complication12 monthsIncidence of a non-cardiovascular complication
the LEE score at first visit12 monthsthe LEE score at first visit

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026