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

Transcranial Doppler (TCD) Ultrasound for Predicting and Understanding Cognitive Decline in Cerebral Vascular Disease.

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

Study Overview

• Status: Completed
• Conditions: Cerebral Vascular Accident (CVA)/Stroke
• Intervention / Treatment: Diagnostic test: Cerebral Autoregulation (CAR); Diagnostic test: Neurovascular coupling (NVC); Diagnostic test: Microembolic signals (MES); Diagnostic test: Montreal Cognitive Assessment (MoCA); Diagnostic test: Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE); Diagnostic test: Instrumental Activities of Daily Living Scale (IADL); Diagnostic test: Modified Rankin Scale for Neurologic Disability (mRS)

• Study Type: Observational
• Enrollment (Actual): 517

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal
    • Centro Hospitalar e Universitário de São João, EPE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population includes participants who suffered a stroke admitted in the stroke unit (Centro Hospitalar Universitário de São João, Porto, Portugal), being included in order of admission. Provide signed and dated informed consent; more than 18 years; Patients with intracerebral haemorrhages; Patients with ischemic stroke of atherosclerotic, cardioembolic and embolic etiology from an unknown source.

Description

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;

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ischemic Stroke (Carotid Circulation); Patients with ischemic stroke of atherosclerotic, cardioembolic and embolic etiology from an unknown source	Diagnostic test: 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; 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 .; Diagnostic test: Microembolic signals (MES); Microembolic signals (MES); Diagnostic test: Montreal Cognitive Assessment (MoCA); Montreal Cognitive Assessment (MoCA); Diagnostic test: Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE); Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE); Diagnostic test: Instrumental Activities of Daily Living Scale (IADL); Instrumental Activities of Daily Living Scale (IADL); Diagnostic test: Modified Rankin Scale for Neurologic Disability (mRS); 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	Diagnostic test: 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; 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 .; Diagnostic test: Microembolic signals (MES); Microembolic signals (MES); Diagnostic test: Montreal Cognitive Assessment (MoCA); Montreal Cognitive Assessment (MoCA); Diagnostic test: Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE); Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE); Diagnostic test: Instrumental Activities of Daily Living Scale (IADL); Instrumental Activities of Daily Living Scale (IADL); Diagnostic test: Modified Rankin Scale for Neurologic Disability (mRS); Modified Rankin Scale for Neurologic Disability (mRS)
Haemorrhagic Stroke; Patients with intracerebral haemorrhages	Diagnostic test: 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; 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 .; Diagnostic test: Microembolic signals (MES); Microembolic signals (MES); Diagnostic test: Montreal Cognitive Assessment (MoCA); Montreal Cognitive Assessment (MoCA); Diagnostic test: Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE); Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE); Diagnostic test: Instrumental Activities of Daily Living Scale (IADL); Instrumental Activities of Daily Living Scale (IADL); Diagnostic test: Modified Rankin Scale for Neurologic Disability (mRS); Modified Rankin Scale for Neurologic Disability (mRS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional status	The modified Rankin Scale (mRS): 0 - None; 1- No significant disability despite symptoms: able to carry out all usual duties and activities; 2 - Slight disability: unable to carry out all previous activities, but able to look after own affairs without assistance; 3 - Moderate disability: requiring some help, but able to walk without assistance; 4 - Moderately severe disability: unable to walk without assistance, unable to attend to needs without assistance; 5 - Severe disability: bed-ridden, incontinent, and requiring constant nursing care and attention; 6 - Dead	3±1 months after onset; 12±1 months after onset
Cognitive status	Cognitive status at 12 months of follow-up will be calculated based in 7-scale cognitive score operationalized from Montreal Cognitive Assessment (MoCA) together with modified Rankin Scale (mRS): - Sub-category Normal: No evidence of cognitive impairment;; - Sub-category Minor Single: Scores are reduced by more than 1 point in only one cognitive domain of MoCA test;; - Sub-category Minor Multi: Scores are reduced by more than 1 point in more than one cognitive domain of MoCA test;; - Sub-category Major Mild: Cognitive impairments (MoCA test 20-25) and minimal functional problems (mRS less than 3);; - Sub-category Major Moderate: More severe cognitive impairments (MoCA test 14-19) and more limiting function (mRS=3 or 4);; - Sub-category Major Severe: Severest cognitive impairments (MoCA less than 14) and most limited function or Moderately severe/severe disability (mRS more than 4);; - Sub-category Death.	12±1 months after onset

Collaborators and Investigators

• Sponsor: Universidade do Porto
• Collaborators: RISE Study Group; Hospital de Sao Joao, Porto
• Investigators: Principal Investigator: Pedro Castro, PhD, Universidade do Porto

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: August 8, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Ischemic Stroke; Haemorrhagic Stroke; Cerebral Vascular Disease
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cardiovascular Diseases; Stroke; Vascular Diseases
• Other Study ID Numbers: SUNRISE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No