Cerebral Vascular Accident (CVA)/StrokeSUNRISENCT06735274
Transcranial Doppler (TCD) Ultrasound and Cognition in Cerebral Vascular Disease. (SUNRISE)
An observational study of Cerebral Vascular Accident (CVA)/Stroke, run by Universidade do Porto at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Vascular Accident (CVA)/Stroke
- What is being tested?
- Cerebral Autoregulation (CAR), Neurovascular coupling (NVC) and Microembolic signals (MES)
- How many people
- 517 participants
- Where
- 1 sitePortugal
- Study dates
- 15 Oct 2020to 30 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Cerebral Vascular Accident (CVA)/Stroke
- Being tested
- Cerebral Autoregulation (CAR), Neurovascular coupling (NVC), Microembolic signals (MES), Montreal Cognitive Assessment (MoCA), Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
- Keywords
- Ischemic Stroke, Haemorrhagic Stroke, Cerebral Vascular Disease
- Medical subject headings
- Stroke, Ischemic Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Ischemic Stroke (Carotid Circulation) | Patients with ischemic stroke of atherosclerotic, cardioembolic and embolic etiology from an unknown source Receives: 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 Receives: 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) | |
| Haemorrhagic Stroke | Patients with intracerebral haemorrhages Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 12±1 months after onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start15 Oct 2020
- Primary completion30 May 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Vascular Accident (CVA)/StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 517 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Sao Joao, Porto, RISE Study Group
- Responsible party
- Sponsor
- Investigators
- Pedro Castro, PhD, Principal investigator, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735274
- Sponsor's protocol ID
- SUNRISE
- Acronym
- SUNRISE
- Status last verified
- Jul 2024
- First submitted
- 8 Aug 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Doppler (TCD) Ultrasound for Predicting and Understanding Cognitive Decline in Cerebral Vascular Disease.
- ClinicalTrials.gov ID
- NCT06735274
- Acronym / sponsor ID
- SUNRISE / SUNRISE
- Conditions
- Cerebral Vascular Accident (CVA)/Stroke
- Keywords
- Ischemic Stroke, Haemorrhagic Stroke, Cerebral Vascular Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 517 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Hospital de Sao Joao, Porto, RISE Study Group
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ischemic Stroke (Carotid Circulation) | – | 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)Patients with ischemic stroke of atherosclerotic, cardioembolic and embolic etiology from an unknown source |
| Ischemic Stroke (Posterior Circulation) | – | 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)Patients with ischemic stroke of atherosclerotic, cardioembolic and embolic etiology from an unknown source |
| Haemorrhagic Stroke | – | 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)Patients with intracerebral haemorrhages |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Haemorrhagic Stroke, Ischemic Stroke (Carotid Circulation), Ischemic Stroke (Posterior Circulation) |
| 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 | Haemorrhagic Stroke, Ischemic Stroke (Carotid Circulation), Ischemic Stroke (Posterior Circulation) |
| Microembolic signals (MES)Microembolic signals (MES) | Diagnostic test | Haemorrhagic Stroke, Ischemic Stroke (Carotid Circulation), Ischemic Stroke (Posterior Circulation) |
| Montreal Cognitive Assessment (MoCA)Montreal Cognitive Assessment (MoCA) | Diagnostic test | Haemorrhagic Stroke, Ischemic Stroke (Carotid Circulation), Ischemic Stroke (Posterior Circulation) |
| Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) | Diagnostic test | Haemorrhagic Stroke, Ischemic Stroke (Carotid Circulation), Ischemic Stroke (Posterior Circulation) |
| Instrumental Activities of Daily Living Scale (IADL)Instrumental Activities of Daily Living Scale (IADL) | Diagnostic test | Haemorrhagic Stroke, Ischemic Stroke (Carotid Circulation), Ischemic Stroke (Posterior Circulation) |
| Modified Rankin Scale for Neurologic Disability (mRS)Modified Rankin Scale for Neurologic Disability (mRS) | Diagnostic test | Haemorrhagic Stroke, Ischemic Stroke (Carotid Circulation), Ischemic Stroke (Posterior Circulation) |
Primary outcome
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
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): 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Castro, PhD principal investigator
Universidade do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Vascular Accident (CVA)/Stroke, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional status (time frame: 3±1 months after onset; 12±1 months after onset). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.