Diabetes and Risk of Ischemic Stroke.

NCT06401902 | Completed

• 1 other identifier: VASC-01-2024
• Study Type: observational
• Target: 3,739
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carotid Stenosis

Keywords

diabetes; ischemic stroke; cerebral hemorrhage; hypoperfusion; hyperperfusion

Outcome Measures

Primary Outcomes (3)

• Intolerance to carotid clamping test

  Occurrence of consciousness perturbations: patient loses consciousness

  During clamping test

• Intolerance to carotid clamping test.

  Language difficulties: the patient no longer answers questions

  During clamping test

• Intolerance to carotid clamping test.

  Contralateral motor deficit: anesthesiologist request to shake hands.

  During clamping test

Study Arms (2)

Diabetics

Diabetics patients who underwent internal carotid artery surgery

Procedure: carotid clamping

Nondiabetics

Nondiabetics patients who underwent internal carotid artery surgery

Procedure: carotid clamping

Interventions

carotid clamping PROCEDURE

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

Diabetics; Nondiabetics

Eligibility Criteria

• Age: 28 Years - 97 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with carotid stenosis requiring carotid surgery.

You may qualify if:

• Patients with clamping test during carotid surgery.

You may not qualify if:

• Patients without clamping test during carotid surgery.

Sponsors & Collaborators

• Institut Mutualiste Montsouris: lead

Study Sites (1)

Mutualist Montsouris Institute

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

Location

MeSH Terms

Conditions

Carotid Stenosis; Diabetes Mellitus; Ischemic Stroke; Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Officials

• Christian Pr PETITJEAN

  Institut Mutualiste Montsouris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 7, 2024
• Study Start: January 1, 1990
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

FR (1)