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Completed

NCT Number: NCT06735274

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

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

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Key information

Conditions

Cerebral Vascular Accident (CVA)/Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhagic Stroke Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro Hospitalar e Universitário de São João, EPE

Porto, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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

Neurovascular coupling (NVC)

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)

Diagnostic Test

Microembolic signals (MES)

Montreal Cognitive Assessment (MoCA)

Diagnostic Test

Montreal Cognitive Assessment (MoCA)

Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)

Diagnostic Test

Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)

Instrumental Activities of Daily Living Scale (IADL)

Diagnostic Test

Instrumental Activities of Daily Living Scale (IADL)

Modified Rankin Scale for Neurologic Disability (mRS)

Diagnostic Test

Modified Rankin Scale for Neurologic Disability (mRS)

Primary outcomes

  1. Functional status

    Time frame: 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

  2. Cognitive status

    Time frame: 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):

    • - 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.

Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Collaborators

  • Hospital de Sao Joao, Porto
  • RISE Study Group

Registry information

Official study title

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

Acronym: SUNRISE

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 16, 2024
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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