Internal Carotid StenosisPhase 3EMOCARNCT01415648
Medico-economic Evaluation of Preoperative Cerebral Oximetry Monitoring During Carotid Endarterectomy
A Phase 3 study testing cerebral oximetry monitoring using INVOS™ and hemodynamic optimisation and standard cerebral monitoring and hemodynamic optimisation in people with Internal Carotid Stenosis, run by Nantes University Hospital at 19 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Internal Carotid Stenosis
- What is being tested?
- cerebral oximetry monitoring using INVOS™ and hemodynamic optimisation and standard cerebral monitoring and hemodynamic optimisation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 879 participants
- Where
- 19 sitesFrance
- Study dates
- Apr 2011to Apr 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Who cannot join
- 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
France19 sites
Besancon University Hospital "Hôpital Jean Minjoz"
Besançon
Bordeaux University Hospital "Haut Lévêque"
Bordeaux
Bordeaux University Hospital "Hôpital Pellegrin"
Bordeaux
Brest University Hospital "La Cavale Blanche"
Brest
Caen University Hospital "Côte de Nacre"
Caen
Dijon University Hospital "Le Bocage"
Dijon
Le Mans Hospital
Le Mans
Hospital de Marie Lannelongue Plessis Robinson
Le Plessis-Robinson
Lyon University Hospital "Hôpital Edouard Herriot"
Lyon
Marseille University Hospital "Hôpital de la Timone"
Marseille
Nantes University Hospital
Nantes, 44000
"Nouvelles Cliniques Nantaises"
Nantes
Nice University Hospital "Saint-Roch"
Nice
"Groupe Hospitalier Saint-Joseph"
Paris
"Hôpital Européen Georges Pompidou"
Paris
Reims University Hospital "Robert Debré"
Reims
Rennes University Hospital "Pontchaillou"
Rennes
Strasbourg University Hospital
Strasbourg
Toulouse University Hospital
Toulouse
About this study
Official title: Medico-economic Evaluation of Preoperative Cerebral Oximetry Monitoring During Carotid Endarterectomy.
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
Read the detailed description
After consent, patients will be randomized in two groups: one group with continuous per operative cerebral oximetry monitoring associated with hemodynamic optimisation algorithm (excluding norepinephrine) if cerebral oximetry decrease more than 15% under the preoperative baseline; the second group is continuously monitored with cerebral oximeter but this latter is blinded to the medical team, the alarm switch off , and patients are managed with the standard care of the centre.
All patients have a preoperative and a postoperative diffusion cerebral MRI to detect new onset of cerebral ischemic lesion. The amount and the volume of cerebral ischemic lesions will be scored to compare groups.
Quality of life as well as direct (medical and nonmedical) and indirect costs were collected using questionnaires during the 120 postoperative days.
A substudy including 200 patients will be conducted to compare the two groups concerning postoperative protein S-100B level and a composite score of neurocognitive tests (measured pre- and postoperatively) The trial will be conducted according to GCP
- Conditions
- Internal Carotid Stenosis
- Being tested
- cerebral oximetry monitoring using INVOS™ and hemodynamic optimisation, standard cerebral monitoring and hemodynamic optimisation
- Keywords
- with surgical indication, Cerebral oximetry, carotid endarterectomy, MRI, ischemic lesion, cost/effectiveness analysis, Neurocognitive Outcome, protein S-100B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cerebral oximetry monitoring using INVOS™ and hemodynamic optimisationOther
Also called INVOS™
continuous per operative cerebral oximetry monitoring associated with hemodynamic optimisation algorithm (excluding norepinephrine) if cerebral oximetry decrease more than 15% under the preoperative baseline
standard cerebral monitoring and hemodynamic optimisationOther
the patient is continously monitored with cerebral oximeter but this latter is blinded to the medical team, the alarm switch off , and patients are managed with the standard care of the centre.
| Study group | Role | What they receive |
|---|---|---|
| open NIRS | Experimental | continuous per operative cerebral oximetry monitoring (using INVOS™ cerebral oximeter) associated with hemodynamic optimisation algorithm (excluding norepinephrine) if cerebral oximetry decrease more than 15% under the preoperative baseline Receives: Other: cerebral oximetry monitoring using INVOS™ and hemodynamic optimisation |
| Blinded NIRS | Sham comparator | Continuously monitored with cerebral oximeter but this latter is blinded to the medical team, the alarm switch off , and patients are managed with the standard care of the centre Receives: Other: standard cerebral monitoring and hemodynamic optimisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of new cerebral ischemic lesions
The number of new cerebral ischemic lesions observed on postoperative diffusion MRI
Measured: Up to 3 days post-operative
Secondary outcomes (7)
Incremental cost-effectiveness ratio comparing the group monitored by cerebral oximeter and the standard care group
Measured: 4 months post-operative
Hospitalization length of stay
Measured: 4 months post-operative
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
Measured: 4 months post-operative
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
Measured: 4 months post-operative
Percentage of patient with Surgical events
- Percentage of patient with surgical site infection
- Percentage of patient with haematoma evacuation
Measured: 4 months post-operative
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
Measured: 4 months post-operative
Incidence of death 4 month postoperatively
Measured: 4 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2015
- Study completionApr 2016
Why it stopped: Recruitment time expired.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Internal Carotid StenosisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 879 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Yann Le Teurnier, MD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415648
- Sponsor's protocol ID
- STIC/10/02
- Other IDs
- 2010-A01167-32
- Acronym
- EMOCAR
- Status last verified
- Nov 2023
- First submitted
- 11 Jul 2011
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Le Teurnier Y, Rozec B, Degryse C, Levy F, Miliani Y, Godet G, Daccache G, Truc C, Steinmetz E, Ouattara A, Cholley B, Malinovsky JM, Portier D, Dupont G, Liutkus D, Viard P, Pere M, Daumas-Duport B, Magras PA, Vourc'h M; EMOCAR Study Group. Optimization of cerebral oxygenation based on regional cerebral oxygen saturation monitoring during carotid endarterectomy: a Phase III multicenter, double-blind randomized controlled trial. Anaesth Crit Care Pain Med. 2024 Aug;43(4):101388. doi: 10.1016/j.accpm.2024.101388. Epub 2024 May 4.
PubMed 38710323
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medico-economic Evaluation of Preoperative Cerebral Oximetry Monitoring During Carotid Endarterectomy.
- ClinicalTrials.gov ID
- NCT01415648
- Acronym / sponsor ID
- EMOCAR / STIC/10/02
- Conditions
- Internal Carotid Stenosis
- Keywords
- with surgical indication, Cerebral oximetry, carotid endarterectomy, MRI, ischemic lesion, cost/effectiveness analysis, Neurocognitive Outcome, protein S-100B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment time expired.
- Enrolment
- 879 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Apr 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 12 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
After consent, patients will be randomized in two groups: one group with continuous per operative cerebral oximetry monitoring associated with hemodynamic optimisation algorithm (excluding norepinephrine) if cerebral oximetry decrease more than 15% under the preoperative baseline; the second group is continuously monitored with cerebral oximeter but this latter is blinded to the medical team, the alarm switch off , and patients are managed with the standard care of the centre.
All patients have a preoperative and a postoperative diffusion cerebral MRI to detect new onset of cerebral ischemic lesion. The amount and the volume of cerebral ischemic lesions will be scored to compare groups.
Quality of life as well as direct (medical and nonmedical) and indirect costs were collected using questionnaires during the 120 postoperative days.
A substudy including 200 patients will be conducted to compare the two groups concerning postoperative protein S-100B level and a composite score of neurocognitive tests (measured pre- and postoperatively) The trial will be conducted according to GCP
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| open NIRS | Experimental | Other: cerebral oximetry monitoring using INVOS™ and hemodynamic optimisationcontinuous per operative cerebral oximetry monitoring (using INVOS™ cerebral oximeter) associated with hemodynamic optimisation algorithm (excluding norepinephrine) if cerebral oximetry decrease more than 15% under the preoperative baseline |
| Blinded NIRS | Sham comparator | Other: standard cerebral monitoring and hemodynamic optimisationContinuously monitored with cerebral oximeter but this latter is blinded to the medical team, the alarm switch off , and patients are managed with the standard care of the centre |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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:
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cerebral oximetry monitoring using INVOS™ and hemodynamic optimisationAlso: INVOS™continuous per operative cerebral oximetry monitoring associated with hemodynamic optimisation algorithm (excluding norepinephrine) if cerebral oximetry decrease more than 15% under the preoperative baseline | Other | open NIRS |
| standard cerebral monitoring and hemodynamic optimisationthe patient is continously monitored with cerebral oximeter but this latter is blinded to the medical team, the alarm switch off , and patients are managed with the standard care of the centre. | Other | Blinded NIRS |
Primary outcome
The number of new cerebral ischemic lesions
Time frame: Up to 3 days post-operative
The number of new cerebral ischemic lesions observed on postoperative diffusion MRI
7 secondary outcomes
Incremental cost-effectiveness ratio comparing the group monitored by cerebral oximeter and the standard care group
Time frame: 4 months post-operative
Hospitalization length of stay
Time frame: 4 months post-operative
Percentage of patient with Neurologic and neurocognitive postoperative disorders
Time frame: 4 months post-operative
Percentage of patient with Cardiovascular postoperative disorders
Time frame: 4 months post-operative
Percentage of patient with Surgical events
Time frame: 4 months post-operative
Postoperative quality of life (SF36, EQ5D tests)
Time frame: 4 months post-operative
Incidence of death 4 month postoperatively
Time frame: 4 months post-operative
Results and safety
The study was stopped early (reason given: Recruitment time expired.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 38710323Le Teurnier Y, Rozec B, Degryse C, Levy F, Miliani Y, Godet G, Daccache G, Truc C, Steinmetz E, Ouattara A, Cholley B, Malinovsky JM, Portier D, Dupont G, Liutkus D, Viard P, Pere M, Daumas-Duport B, Magras PA, Vourc'h M; EMOCAR Study Group. Optimization of cerebral oxygenation based on regional cerebral oxygen saturation monitoring during carotid endarterectomy: a Phase III multicenter, double-blind randomized controlled trial. Anaesth Crit Care Pain Med. 2024 Aug;43(4):101388. doi: 10.1016/j.accpm.2024.101388. Epub 2024 May 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yann Le Teurnier, MD principal investigator
Nantes University Hospital
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cerebral oximetry monitoring using INVOS™ and hemodynamic optimisation and standard cerebral monitoring and hemodynamic optimisation in people with Internal Carotid Stenosis, run by Nantes University Hospital at 19 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment time expired.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of new cerebral ischemic lesions (time frame: Up to 3 days post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01415648, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.