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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

517

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.9 years study duration

Study Start

First participant enrolled

October 15, 2020

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed

11 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2024

Completed

4 months until next milestone

First Posted

Study publicly available on registry

December 16, 2024

Completed

Last Updated

December 16, 2024

Status Verified

July 1, 2024

Enrollment Period

2.6 years

First QC Date

August 8, 2024

Last Update Submit

December 10, 2024

Conditions

Cerebral Vascular Accident (CVA)/Stroke

Keywords

Ischemic StrokeHaemorrhagic StrokeCerebral Vascular Disease

Outcome Measures

Primary Outcomes (2)

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): 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.
12±1 months after onset

Study Arms (3)

Ischemic Stroke (Carotid Circulation)

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

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)

Ischemic Stroke (Posterior Circulation)

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

Haemorrhagic Stroke

Patients with intracerebral haemorrhages

Interventions

Cerebral Autoregulation (CAR)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