Internal Carotid Stenosis Clinical Trial
— EMOCAROfficial title:
Medico-economic Evaluation of Preoperative Cerebral Oximetry Monitoring During Carotid Endarterectomy.
| Verified date | November 2023 |
| Source | Nantes University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
In France, in 2007, 17 000 patients underwent carotid endarterectomy. The risk of having an ipsilateral postoperative stroke after carotid endarterectomy remains at 1-1.5%. There is no consensus concerning the best cerebral monitoring and hemodynamic optimisation during carotid cross-clamping. The objective of this prospective, multicentric, double-blinded and randomized study is to evaluate the interest of continuous cerebral oximetry monitoring by INVOS™ cerebral oximeter to direct the hemodynamic optimisation during carotid endarterectomy and reduce the new-onset of postoperative radiological (MRI) ischemic lesions. A cost/effectiveness analysis will be conducted to estimate the impact of this monitoring versus standard care on direct and indirect postoperative costs during 120 days. A substudy will evaluate the effect of this monitoring on neurocognitive outcome and on a serum marker of brain injury, protein S-100B
| Status | Terminated |
| Enrollment | 879 |
| Est. completion date | April 2016 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patients (male-female) over 18 y.o. - Presenting an internal carotid stenosis requiring surgery - Mini Mental State Examination >24 during preoperative examination - Informed written consentExclusion Criteria: Exclusion criteria: - Severe renal failure or requiring dialysis - Liver failure or cirrhosis (Child class = B) or prothrombin activity<50% - Heart failure (NYHA = III), left ventricular ejection fraction < 40%, acute coronary syndrome, - Associated surgery - Pregnancy - Contraindication to MRI - History of allergy to modified gelatine or starch - History of allergy to adhesive part of electrode |
| Country | Name | City | State |
|---|---|---|---|
| France | Besancon University Hospital "Hôpital Jean Minjoz" | Besancon | |
| France | Bordeaux University Hospital "Haut Lévêque" | Bordeaux | |
| France | Bordeaux University Hospital "Hôpital Pellegrin" | Bordeaux | |
| France | Brest University Hospital "La Cavale Blanche" | Brest | |
| France | Caen University Hospital "Côte de Nacre" | Caen | |
| France | Dijon University Hospital "Le Bocage" | Dijon | |
| France | Le Mans Hospital | Le Mans | |
| France | Hospital de Marie Lannelongue Plessis Robinson | Le Plessis Robinson | |
| France | Lyon University Hospital "Hôpital Edouard Herriot" | Lyon | |
| France | Marseille University Hospital "Hôpital de la Timone" | Marseille | |
| France | "Nouvelles Cliniques Nantaises" | Nantes | |
| France | Nantes University Hospital | Nantes | |
| France | Nice University Hospital "Saint-Roch" | Nice | |
| France | "Groupe Hospitalier Saint-Joseph" | Paris | |
| France | "Hôpital Européen Georges Pompidou" | Paris | |
| France | Reims University Hospital "Robert Debré" | Reims | |
| France | Rennes University Hospital "Pontchaillou" | Rennes | |
| France | Strasbourg University Hospital | Strasbourg | |
| France | Toulouse University Hospital | Toulouse |
| Lead Sponsor | Collaborator |
|---|---|
| Nantes University Hospital | Ministry of Health, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The number of new cerebral ischemic lesions | The number of new cerebral ischemic lesions observed on postoperative diffusion MRI | Up to 3 days post-operative | |
| Secondary | Incremental cost-effectiveness ratio comparing the group monitored by cerebral oximeter and the standard care group | 4 months post-operative | ||
| Secondary | Hospitalization length of stay | 4 months post-operative | ||
| Secondary | Percentage of patient with Neurologic and neurocognitive postoperative disorders | Percentage of patient with Spatiotemporal disorientation
Percentage of patient with aphasia Percentage of patient with Facial paralysis Percentage of patient with Limb sensory or motor deficit Percentage of patient with Seizure Percentage of patient with Balance disorder |
4 months post-operative | |
| Secondary | Percentage of patient with Cardiovascular postoperative disorders | Percentage of patient with myocardial infaction
Percentage of patient with atrial fibrillation or atrial flutter Percentage of patient with acute left ventricle failure Percentage of patient with Uncontrolled high blood pressure |
4 months post-operative | |
| Secondary | Percentage of patient with Surgical events | Percentage of patient with surgical site infection
Percentage of patient with haematoma evacuation |
4 months post-operative | |
| Secondary | Postoperative quality of life (SF36, EQ5D tests) | SF36 score for quality of life assessment :
Physical quality score [Time Frame: Through study completion, 4 month postoperatively] Items from the SF36 (Short Form 36) survey Mental quality score [Time Frame: Through study completion, 4 month postoperatively] Items from the SF36 (Short Form 36) survey EQ5D3L test for quality of life assessment : Quality of life evaluated by the EQ 5D 3L questionnaire [Time Frame: 4 months postoperatively] Quality of life, as evaluated by the use EQ 5D 3L auto-questionnaire |
4 months post-operative | |
| Secondary | Incidence of death 4 month postoperatively | 4 months post-operative |