Carotid StenosisNCT06401902
Diabetes and Risk of Ischemic Stroke.
An observational study of Carotid Stenosis, run by Institut Mutualiste Montsouris at 1 site in France.
Trial summary
Diabetes in an independent risk factor for ischemic stroke, whose associated mortality rate is higher and sequelae more serious than for nondiabetics. Diabetes increases the risk of stroke or death after surgical carotid revascularization or endoluminal angioplasty. Read more about this study
- Who is it for?
- Ages 28 to 97 years
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- carotid clamping
- Type of treatment
- Surgery or procedure
- How many people
- 3,739 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 1990to 30 Jun 2019
- Phase
- Observational
- 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 28 to 97 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with carotid stenosis requiring carotid surgery.
Who may be able to join
- Patients with clamping test during carotid surgery.
Who cannot join
- Patients without clamping test during carotid surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diabetes and Stroke: Does an Excess Risk of Hemodynamic Cerebral Ischemia Exist?
Diabetes in an independent risk factor for ischemic stroke, whose associated mortality rate is higher and sequelae more serious than for nondiabetics. Diabetes increases the risk of stroke or death after surgical carotid revascularization or endoluminal angioplasty. It is, with contralateral ICA occlusion, 1 of the 7 factors doubling the stroke risk after carotid endarterectomy. Diabetes also enhances the cerebral hemorrhage risk associated with carotid surgery, thrombectomy or thrombolysis revascularization of the cerebral arteries.
This study was undertaken to examine whether the hemodynamic cerebral ischemia (HCI) frequency, which increases stroke severity, is higher in diabetics than nondiabetics and, if diabetes carries an excess HCI risk, whether it is independent of contralateral ICA occlusion.
Read the detailed description
Embolic and hemodynamic mechanisms are the main causes underlying ischemic strokes of carotid origin. The hemodynamic cerebral ischemia (HCI) risk depends on the contribution of the contralateral internal carotid artery (ICA) and vertebral arteries via the circle of Willis, the ipsilateral external carotid artery via the ophthalmic artery and the leptomeningeal arteries. During carotid surgery, impaired collateral flow is associated with the need for shunt insertion.
When HCI is present, cerebral perfusion is initially maintained by vasodilation of precapillary arterioles and the increased extraction coefficient of oxygen. Secondarily, vascular reserve exhaustion by degradation of arterial lesions engenders a loss of cerebral autoregulation, ischemic penumbra and cerebral infarction.
Carotid revascularization with an incomplete circle of Willis enhances the postoperative ischemic stroke risk. The loss of cerebral autoregulation, attributable to HCI combined with ipsilateral carotid tight stenosis, heightens the risk of hyperperfusion and cerebral hemorrhage.
Carotid occlusion is the primary cause of HCI. Carotid occlusions and tight stenoses lead to loss of cerebral autoregulation and cerebrovascular reserve, and have been associated with a 4-fold-increased stroke risk.
Diabetes in an independent risk factor for ischemic stroke, whose associated mortality rate is higher and sequelae more serious than for nondiabetics. Diabetes increases the risk of stroke or death after surgical carotid revascularization or endoluminal angioplasty.It is, with contralateral ICA occlusion, 1 of the 7 factors doubling the stroke risk after carotid endarterectomy. Diabetes also enhances the cerebral hemorrhage risk associated with carotid surgery, thrombectomy or thrombolysis revascularization of the cerebral arteries.
This study was undertaken to examine whether the HCI frequency is higher in diabetics than nondiabetics and, if diabetes carries an excess HCI risk, whether it is independent of contralateral ICA occlusion.
- Conditions
- Carotid Stenosis
- Being tested
- carotid clamping
- Keywords
- diabetes, ischemic stroke, cerebral hemorrhage, hypoperfusion, hyperperfusion
- Medical subject headings
- Carotid Stenosis, Diabetes Mellitus, Ischemic Stroke, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carotid clampingProcedure or surgery
Occurrence of consciousness perturbations, language difficulties and/or contralateral motor deficit during the carotid-clamping test and requiring shunt placement.
| Study group | Role | What they receive |
|---|---|---|
| Diabetics | Diabetics patients who underwent internal carotid artery surgery Receives: Procedure: carotid clamping | |
| Nondiabetics | Nondiabetics patients who underwent internal carotid artery surgery Receives: Procedure: carotid clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intolerance to carotid clamping test
Occurrence of consciousness perturbations: patient loses consciousness
Measured: During clamping test
Intolerance to carotid clamping test.
Language difficulties: the patient no longer answers questions
Measured: During clamping test
Intolerance to carotid clamping test.
Contralateral motor deficit: anesthesiologist request to shake hands.
Measured: During clamping test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 Jan 1990
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,739 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Mutualiste Montsouris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Pr PETITJEAN, Principal investigator, Institut Mutualiste Montsouris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401902
- Sponsor's protocol ID
- VASC-01-2024
- Status last verified
- May 2024
- First submitted
- 2 May 2024
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes and Stroke: Does an Excess Risk of Hemodynamic Cerebral Ischemia Exist?
- ClinicalTrials.gov ID
- NCT06401902
- Acronym / sponsor ID
- VASC-01-2024
- Conditions
- Carotid Stenosis
- Keywords
- diabetes, ischemic stroke, cerebral hemorrhage, hypoperfusion, hyperperfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,739 participants (actual)
- Lead sponsor
- Institut Mutualiste MontsourisUniversity, hospital or other
- Study start
- 1 Jan 1990 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 7 May 2024 (actual)
- 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.
Diabetes in an independent risk factor for ischemic stroke, whose associated mortality rate is higher and sequelae more serious than for nondiabetics. Diabetes increases the risk of stroke or death after surgical carotid revascularization or endoluminal angioplasty. It is, with contralateral ICA occlusion, 1 of the 7 factors doubling the stroke risk after carotid endarterectomy. Diabetes also enhances the cerebral hemorrhage risk associated with carotid surgery, thrombectomy or thrombolysis revascularization of the cerebral arteries.
This study was undertaken to examine whether the hemodynamic cerebral ischemia (HCI) frequency, which increases stroke severity, is higher in diabetics than nondiabetics and, if diabetes carries an excess HCI risk, whether it is independent of contralateral ICA occlusion.
Detailed description
Embolic and hemodynamic mechanisms are the main causes underlying ischemic strokes of carotid origin. The hemodynamic cerebral ischemia (HCI) risk depends on the contribution of the contralateral internal carotid artery (ICA) and vertebral arteries via the circle of Willis, the ipsilateral external carotid artery via the ophthalmic artery and the leptomeningeal arteries. During carotid surgery, impaired collateral flow is associated with the need for shunt insertion.
When HCI is present, cerebral perfusion is initially maintained by vasodilation of precapillary arterioles and the increased extraction coefficient of oxygen. Secondarily, vascular reserve exhaustion by degradation of arterial lesions engenders a loss of cerebral autoregulation, ischemic penumbra and cerebral infarction.
Carotid revascularization with an incomplete circle of Willis enhances the postoperative ischemic stroke risk. The loss of cerebral autoregulation, attributable to HCI combined with ipsilateral carotid tight stenosis, heightens the risk of hyperperfusion and cerebral hemorrhage.
Carotid occlusion is the primary cause of HCI. Carotid occlusions and tight stenoses lead to loss of cerebral autoregulation and cerebrovascular reserve, and have been associated with a 4-fold-increased stroke risk.
Diabetes in an independent risk factor for ischemic stroke, whose associated mortality rate is higher and sequelae more serious than for nondiabetics. Diabetes increases the risk of stroke or death after surgical carotid revascularization or endoluminal angioplasty.It is, with contralateral ICA occlusion, 1 of the 7 factors doubling the stroke risk after carotid endarterectomy. Diabetes also enhances the cerebral hemorrhage risk associated with carotid surgery, thrombectomy or thrombolysis revascularization of the cerebral arteries.
This study was undertaken to examine whether the HCI frequency is higher in diabetics than nondiabetics and, if diabetes carries an excess HCI risk, whether it is independent of contralateral ICA occlusion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetics | – | Procedure: carotid clampingDiabetics patients who underwent internal carotid artery surgery |
| Nondiabetics | – | Procedure: carotid clampingNondiabetics patients who underwent internal carotid artery surgery |
Who may qualify
- Ages
- 28 to 97 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with carotid stenosis requiring carotid surgery.
Key inclusion criteria (1 listed)
- Patients with clamping test during carotid surgery.
Key exclusion criteria (1 listed)
- Patients without clamping test during carotid surgery.
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 |
|---|---|---|
| carotid clampingOccurrence of consciousness perturbations, language difficulties and/or contralateral motor deficit during the carotid-clamping test and requiring shunt placement. | Procedure or surgery | Diabetics, Nondiabetics |
Primary outcome
Intolerance to carotid clamping test
Time frame: During clamping test
Occurrence of consciousness perturbations: patient loses consciousness
Intolerance to carotid clamping test.
Time frame: During clamping test
Language difficulties: the patient no longer answers questions
Intolerance to carotid clamping test.
Time frame: During clamping test
Contralateral motor deficit: anesthesiologist request to shake hands.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
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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.
Christian Pr PETITJEAN principal investigator
Institut Mutualiste Montsouris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Stenosis, run by Institut Mutualiste Montsouris at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intolerance to carotid clamping test (time frame: During clamping test). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2024.