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

NCT ID: NCT06735274

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

517 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-15

Study Completion Date

2023-08-30

Brief Summary

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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

Detailed Description

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Conditions

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Cerebral Vascular Accident (CVA)/Stroke

Keywords

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Ischemic Stroke Haemorrhagic Stroke Cerebral Vascular Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ischemic Stroke (Carotid Circulation)

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

Cerebral Autoregulation (CAR)

Intervention Type DIAGNOSTIC_TEST

Cerebral Autoregulation (CAR) is the mechanism capable of maintaining cerebral blood flow constant despite fluctuations in blood pressure. The evaluation of dynamic CAR (dCAR) with spontaneous blood pressure variations allows it to be applied in acute and non-collaborating patients

Neurovascular coupling (NVC)

Intervention Type DIAGNOSTIC_TEST

Neurovascular coupling (NVC) is the relationship between neural activity and cerebral blood flow, allowing this activity to be evaluated in spatiotemporal terms .

Microembolic signals (MES)

Intervention Type DIAGNOSTIC_TEST

Microembolic signals (MES)

Montreal Cognitive Assessment (MoCA)

Intervention Type DIAGNOSTIC_TEST

Montreal Cognitive Assessment (MoCA)

Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)

Intervention Type DIAGNOSTIC_TEST

Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)

Instrumental Activities of Daily Living Scale (IADL)

Intervention Type DIAGNOSTIC_TEST

Instrumental Activities of Daily Living Scale (IADL)

Modified Rankin Scale for Neurologic Disability (mRS)

Intervention Type DIAGNOSTIC_TEST

Modified Rankin Scale for Neurologic Disability (mRS)

Ischemic Stroke (Posterior Circulation)

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

Cerebral Autoregulation (CAR)

Intervention Type DIAGNOSTIC_TEST

Cerebral Autoregulation (CAR) is the mechanism capable of maintaining cerebral blood flow constant despite fluctuations in blood pressure. The evaluation of dynamic CAR (dCAR) with spontaneous blood pressure variations allows it to be applied in acute and non-collaborating patients

Neurovascular coupling (NVC)

Intervention Type DIAGNOSTIC_TEST

Neurovascular coupling (NVC) is the relationship between neural activity and cerebral blood flow, allowing this activity to be evaluated in spatiotemporal terms .

Microembolic signals (MES)

Intervention Type DIAGNOSTIC_TEST

Microembolic signals (MES)

Montreal Cognitive Assessment (MoCA)

Intervention Type DIAGNOSTIC_TEST

Montreal Cognitive Assessment (MoCA)

Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)

Intervention Type DIAGNOSTIC_TEST

Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)

Instrumental Activities of Daily Living Scale (IADL)

Intervention Type DIAGNOSTIC_TEST

Instrumental Activities of Daily Living Scale (IADL)

Modified Rankin Scale for Neurologic Disability (mRS)

Intervention Type DIAGNOSTIC_TEST

Modified Rankin Scale for Neurologic Disability (mRS)

Haemorrhagic Stroke

Patients with intracerebral haemorrhages

Cerebral Autoregulation (CAR)

Intervention Type DIAGNOSTIC_TEST

Cerebral Autoregulation (CAR) is the mechanism capable of maintaining cerebral blood flow constant despite fluctuations in blood pressure. The evaluation of dynamic CAR (dCAR) with spontaneous blood pressure variations allows it to be applied in acute and non-collaborating patients

Neurovascular coupling (NVC)

Intervention Type DIAGNOSTIC_TEST

Neurovascular coupling (NVC) is the relationship between neural activity and cerebral blood flow, allowing this activity to be evaluated in spatiotemporal terms .

Microembolic signals (MES)

Intervention Type DIAGNOSTIC_TEST

Microembolic signals (MES)

Montreal Cognitive Assessment (MoCA)

Intervention Type DIAGNOSTIC_TEST

Montreal Cognitive Assessment (MoCA)

Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)

Intervention Type DIAGNOSTIC_TEST

Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)

Instrumental Activities of Daily Living Scale (IADL)

Intervention Type DIAGNOSTIC_TEST

Instrumental Activities of Daily Living Scale (IADL)

Modified Rankin Scale for Neurologic Disability (mRS)

Intervention Type DIAGNOSTIC_TEST

Modified Rankin Scale for Neurologic Disability (mRS)

Interventions

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Cerebral Autoregulation (CAR)

Cerebral Autoregulation (CAR) is the mechanism capable of maintaining cerebral blood flow constant despite fluctuations in blood pressure. The evaluation of dynamic CAR (dCAR) with spontaneous blood pressure variations allows it to be applied in acute and non-collaborating patients

Intervention Type DIAGNOSTIC_TEST

Neurovascular coupling (NVC)

Neurovascular coupling (NVC) is the relationship between neural activity and cerebral blood flow, allowing this activity to be evaluated in spatiotemporal terms .

Intervention Type DIAGNOSTIC_TEST

Microembolic signals (MES)

Microembolic signals (MES)

Intervention Type DIAGNOSTIC_TEST

Montreal Cognitive Assessment (MoCA)

Montreal Cognitive Assessment (MoCA)

Intervention Type DIAGNOSTIC_TEST

Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)

Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)

Intervention Type DIAGNOSTIC_TEST

Instrumental Activities of Daily Living Scale (IADL)

Instrumental Activities of Daily Living Scale (IADL)

Intervention Type DIAGNOSTIC_TEST

Modified Rankin Scale for Neurologic Disability (mRS)

Modified Rankin Scale for Neurologic Disability (mRS)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Sao Joao, Porto

UNKNOWN

Sponsor Role collaborator

RISE Study Group

NETWORK

Sponsor Role collaborator

Universidade do Porto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pedro Castro, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade do Porto

Locations

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Centro Hospitalar e Universitário de São João, EPE

Porto, , Portugal

Site Status

Countries

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Portugal

Other Identifiers

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SUNRISE

Identifier Type: -

Identifier Source: org_study_id