Diabetes and Risk of Ischemic Stroke.

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.

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Key information

Conditions

Carotid Stenosis Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hemorrhage Intracranial Hemorrhages Ischemic Stroke Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

28 year–97 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mutualist Montsouris Institute

Paris, Île-de-France Region, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with clamping test during carotid surgery.

Exclusion criteria

Patients without clamping test during carotid surgery.

Treatment and study plan

carotid clamping

Procedure

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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Institut Mutualiste Montsouris

Other

Registry information

Official study title

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

Important dates

Study start: 1990
Primary completion: 2019
Study completion: 2019
First posted: May 7, 2024
Registry last updated: May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed