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

Completed

• Conditions: Cerebral Vascular Accident (CVA)/Stroke

• Registration Number: NCT06735274
• Lead Sponsor: Universidade do Porto

Brief Summary

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

Not available

Study Timeline

• Study Start: 2020-10-15
• Primary Completion: 2023-05-30
• Study Completion: 2023-08-30
• Status Verified: 2024-07
• Study First Submitted: 2024-08-08
• Study First Submitted QC: 2024-12-10
• Last Update Submitted: 2024-12-10
• Study First Posted: 2024-12-16
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 517

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional status	3±1 months after onset; 12±1 months after onset	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
Cognitive status	12±1 months after onset	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): 1. - Sub-category Normal: No evidence of cognitive impairment; 2. - Sub-category Minor Single: Scores are reduced by more than 1 point in only one cognitive domain of MoCA test; 3. - Sub-category Minor Multi: Scores are reduced by more than 1 point in more than one cognitive domain of MoCA test; 4. - Sub-category Major Mild: Cognitive impairments (MoCA test 20-25) and minimal functional problems (mRS less than 3); 5. - Sub-category Major Moderate: More severe cognitive impairments (MoCA test 14-19) and more limiting function (mRS=3 or 4); 6. - Sub-category Major Severe: Severest cognitive impairments (MoCA less than 14) and most limited function or Moderately severe/severe disability (mRS more than 4); 7. - Sub-category Death.

Trial Locations

Locations (1)

Centro Hospitalar e Universitário de São João, EPE; 🇵🇹 Porto, Portugal