Diabetes and Risk of Ischemic Stroke.

Carotid Stenosis Clinical Trial

Official title:

Diabetes and Stroke: Does an Excess Risk of Hemodynamic Cerebral Ischemia Exist?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06401902
• Other study ID #: VASC-01-2024
• Status: Completed
• Start date: January 1, 1990
• Est. completion date: June 30, 2019

Study information

• Verified date: May 2024
• Source: Institut Mutualiste Montsouris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3739
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Years to 97 Years

Eligibility

Inclusion Criteria:

• Patients with clamping test during carotid surgery.

Exclusion Criteria:

• Patients without clamping test during carotid surgery.

Related Conditions & MeSH terms

• Carotid Stenosis

Intervention

Procedure:
• carotid clamping
Occurrence of consciousness perturbations, language difficulties and/or contralateral motor deficit during the carotid-clamping test and requiring shunt placement.

Locations

Country	Name	City	State
France	Mutualist Montsouris Institute	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Institut Mutualiste Montsouris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intolerance to carotid clamping test	Occurrence of consciousness perturbations: patient loses consciousness	During clamping test
Primary	Intolerance to carotid clamping test.	Language difficulties: the patient no longer answers questions	During clamping test
Primary	Intolerance to carotid clamping test.	Contralateral motor deficit: anesthesiologist request to shake hands.	During clamping test