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
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Complications||Diagnostic Test: Blood sampling for HbNO assessment||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: Blood sampling for HbNO assessment||
Diagnostic Test: Blood sampling for HbNO assessment
- 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
- the duration of hospitalization [ Time Frame: 12 months ]the duration of hospitalization
- the duration of residence in intensive care [ Time Frame: 12 months ]the duration of residence in intensive care
- the need for a follow-up by a cardiologist [ Time Frame: 12 months ]the need for a follow-up by a cardiologist
- Incidence of a non-cardiovascular complication [ Time Frame: 12 months ]Incidence of a non-cardiovascular complication
- the LEE score at first visit [ Time Frame: 12 months ]the LEE score at first visit
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994900
|Contact: Nancy Van Overstraeten, PhD Irfirstname.lastname@example.org|
|Cliniques Universitaires St Luc|
|Brussels, Belgium, 1200|
|Contact: Nancy Van Overstraeten, PhD Ir 027645288 email@example.com|
|Principal Investigator: Jean-Luc Balligand, Prof MD|
|Sub-Investigator: Marie-Agnès Docquier, MD|
|Sub-Investigator: Mona Momeni, MD|