Transcranial Doppler (TCD) Ultrasound and Cognition in Cerebral Vascular Disease. (SUNRISE)

Universidade do Porto

Status: Completed

Conditions: Cerebral Vascular Accident (CVA)/Stroke

Treatments: Diagnostic Test: Microembolic signals (MES); Diagnostic Test: Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE); Diagnostic Test: Modified Rankin Scale for Neurologic Disability (mRS); Diagnostic Test: Neurovascular coupling (NVC); Diagnostic Test: Montreal Cognitive Assessment (MoCA); Diagnostic Test: Cerebral Autoregulation (CAR); Diagnostic Test: Instrumental Activities of Daily Living Scale (IADL)

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT06735274

SUNRISE

Details and patient eligibility

About

This study aims to contribute to the identification of factors that may be predictive of cognitive function and to provide data on cerebral hemodynamic in ischemic and haemorrhagic stroke. This study will prospectively study cerebral autoregulation, neurovascular coupling and microembolic signs in cerebrovascular patients with ischemic and haemorrhagic stroke and its relationship with cognitive function and functional recovery

Enrollment: 517 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Minimum age limit: 18 years
• Patients with intracerebral haemorrhages; Patients with ischemic stroke of atherosclerotic, cardioembolic and embolic etiology from an unknown source;
• Previous mRS equal or more than 4;
• National Institutes of Health Stroke Scale (NIHSS)≤20 at admission;
• IQCODE final score<3.0

Exclusion criteria

• History of dementia or other central nervous system disease associated with cognitive impairment;
• Absence of adequate temporal bone window for Transcranial Doppler monitoring;
• Patients with a large cerebral infarct (greater than on third of the middle cerebral artery territory) or a strategic infarct (paramedian thalamus, medial frontal cortex, or hippocampus) evaluated in the 24 hours-CT;
• Average life expectancy less than 1 year for a different cause of cardiovascular disease;
• Patients with intracranial vascular malformation, intracranial venous thrombosis, head trauma or tumour and haemorrhagic transformation within an infarct;
• Serious kidney and systemic diseases;
• Active cancer patients;

Trial design

517 participants in 3 patient groups

Ischemic Stroke (Carotid Circulation)

Description:

Patients with ischemic stroke of atherosclerotic, cardioembolic and embolic etiology from an unknown source

Treatment:

Diagnostic Test: Instrumental Activities of Daily Living Scale (IADL)

Diagnostic Test: Montreal Cognitive Assessment (MoCA)

Diagnostic Test: Cerebral Autoregulation (CAR)

Diagnostic Test: Neurovascular coupling (NVC)

Diagnostic Test: Modified Rankin Scale for Neurologic Disability (mRS)

Diagnostic Test: Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)

Diagnostic Test: Microembolic signals (MES)

Ischemic Stroke (Posterior Circulation)

Description:

Patients with ischemic stroke of atherosclerotic, cardioembolic and embolic etiology from an unknown source

Treatment:

Diagnostic Test: Instrumental Activities of Daily Living Scale (IADL)

Diagnostic Test: Montreal Cognitive Assessment (MoCA)

Diagnostic Test: Cerebral Autoregulation (CAR)

Diagnostic Test: Neurovascular coupling (NVC)

Diagnostic Test: Modified Rankin Scale for Neurologic Disability (mRS)

Diagnostic Test: Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)

Diagnostic Test: Microembolic signals (MES)

Haemorrhagic Stroke

Description:

Patients with intracerebral haemorrhages

Treatment:

Diagnostic Test: Instrumental Activities of Daily Living Scale (IADL)

Diagnostic Test: Montreal Cognitive Assessment (MoCA)

Diagnostic Test: Cerebral Autoregulation (CAR)

Diagnostic Test: Neurovascular coupling (NVC)

Diagnostic Test: Modified Rankin Scale for Neurologic Disability (mRS)

Diagnostic Test: Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)

Diagnostic Test: Microembolic signals (MES)