StrokePRODA-STROKENCT04956185
Data Collection of Patients Admitted to the Stroke Unit
An observational study of Stroke and Stroke, Acute, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The purpose of this prospective observational study is to create a database in which data will be collected from every patient admitted to the Stroke unit and who has explicitly given his or her informed consent for this data collection. The data that will be collected are part of the standard clinical data. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Stroke, Acute, Stroke, Ischemic
- How many people
- 5,000 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Apr 2021to 1 Feb 2031
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients admitted to the Stroke unit (or to any other hospital ward) with a cerebrovascular disease and who have given their informed consent for data collection (or whose legal representative has given informed consent for data collection).
Who may be able to join
- Patients admitted to the Stroke unit with a cerebrovascular disease
- Patients admitted to the regular neurological ward or any other department in the University Hospital Ghent with a cerebrovascular disease who are actively followed by the department of Neurology during hospitalisation
- Patients who have given their explicit informed consent for data collection
Who cannot join
- Patients who have not given informed consent for data collection
- Patients who are not able to give informed consent and whose legal representative has not given informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Department of Neurology - Ghent University Hospital
Ghent, Flanders, 9000
Veerle De Herdt, MD, PhD, +32-9-3324529, Veerle.DeHerdt@ugent.be
About this study
Official title: Prospective Data Collection of Patients Admitted to the Stroke Unit At University Hospital Ghent
The purpose of this prospective observational study is to create a database in which data will be collected from every patient admitted to the Stroke unit and who has explicitly given his or her informed consent for this data collection. The data that will be collected are part of the standard clinical data. No additional investigations, blood tests or any other tests will be performed. The purpose of this database is to conduct retrospective observational research in the future and will allow the hospital to keep track of some important quality indicators in stroke care.
Read the detailed description
Every patient that is admitted to the Stroke unit will be asked if his or her data and relevant personal information can be registered in a database with the purpose of conducting research in the future. If he or she agrees, one of the researchers will go through the Informed Consent Form together with the patient. If the patient has questions, the researcher will answer them. If the patient then agrees to the data collection, he or she will sign the Informed Consent Form.
The data that will be collected are part of the standard clinical data. No additional investigations, blood tests or any other tests will be performed. We will collect the following data:
- Demographical information: gender, year of birth
- Relevant medical history: vascular risk profile, neurological history, psychiatric history, pre-stroke modified Rankin Score (mRS), home medication
- Neurological evaluation upon admission to Emergency Department: vital parameters, clinical neurological evaluation, results imaging
- Data concerning acute stroke therapy: intravenous thrombolysis, intra-arterial thrombectomy, medication started at the Emergency Department, neurosurgical procedures if performed, (neurological) evaluation after treatment
- Course of hospitalisation: complications (neurological deterioration, epilepsy, infections, falls, speech or swallow disturbances, thrombo-embolic complications, pain, cardiac complications), start of medication, treatment (such as physiotherapy, occupational therapy), date of discharge, mRS and NIHSS score at discharge, care after discharge
- Results stroke-investigations: imaging of brain and neck vessels, telemetry, Holter monitoring, transthoracic and/or transesophageal ultrasound, blood workup, electro-encephalographic investigations, genetic workup, etiology of stroke
- Therapy at discharge: medication, revalidation
- mRS score during follow-up at policlinic neurology
The purpose of this database is to conduct retrospective observational research in the future and will allow the hospital to keep track of some important quality indicators in stroke care.
- Conditions
- Stroke, Stroke, Acute, Stroke, Ischemic, Stroke Hemorrhagic, Stroke Sequelae
- Medical subject headings
- Stroke, Ischemic Stroke, Hemorrhagic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristics of study population
Information about patients included in the stroke database: age, gender, medical/family history
Measured: date of inclusion until end of follow-up (12 months)
Onset-to-door
Time between stroke onset and arrival at Emergency Department
Measured: date of inclusiondate of inclusion until end of follow-up (12 months)
Patients treated with acute stroke therapy
Patients treated with acute stroke therapy (i.e. thrombolysis and/or thrombectomy), start time of acute therapy
Measured: date of inclusion until end of follow-up (12 months)
Outcome after acute therapy
Outcome after acute therapy, assessed by NIHSS and mRS score, possible complications and imaging
Measured: date of inclusion until end of follow-up (12 months)
Incidence of complications at stroke unit
Incidence of neurological complications, epilepsy, infections, falls, thrombo-embolic complications, cardiac complications, pain
Measured: date of inclusion until end of follow-up (12 months)
Etiology of stroke
Etiology of stroke, with a distinction between ischaemic stroke, hemorrhagic stroke, subarachnoid stroke or other
Measured: date of inclusion until end of follow-up (12 months)
Mortality and disability after admission to Stroke unit
Mortality and (severity of) disability after admission to stroke unit
Measured: date of discharge until end of follow-up (12 months)
Secondary outcomes (1)
Quality of stroke care
Quality of care at Stroke unit of the University Hospital Ghent
Measured: date of inclusion until end of follow-up (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start29 Apr 2021
- Primary completion1 Feb 2031 (estimated)
- Study completion1 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956185
- Sponsor's protocol ID
- BC-09645
- Acronym
- PRODA-STROKE
- Status last verified
- Jan 2025
- First submitted
- 29 Apr 2021
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Data Collection of Patients Admitted to the Stroke Unit At University Hospital Ghent
- ClinicalTrials.gov ID
- NCT04956185
- Acronym / sponsor ID
- PRODA-STROKE / BC-09645
- Conditions
- Stroke, Stroke, Acute, Stroke, Ischemic, Stroke Hemorrhagic, Stroke Sequelae
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 1 Feb 2031 (estimated)
- Study completion
- 1 Feb 2031 (estimated)
- First posted
- 9 Jul 2021 (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.
The purpose of this prospective observational study is to create a database in which data will be collected from every patient admitted to the Stroke unit and who has explicitly given his or her informed consent for this data collection. The data that will be collected are part of the standard clinical data. No additional investigations, blood tests or any other tests will be performed. The purpose of this database is to conduct retrospective observational research in the future and will allow the hospital to keep track of some important quality indicators in stroke care.
Detailed description
Every patient that is admitted to the Stroke unit will be asked if his or her data and relevant personal information can be registered in a database with the purpose of conducting research in the future. If he or she agrees, one of the researchers will go through the Informed Consent Form together with the patient. If the patient has questions, the researcher will answer them. If the patient then agrees to the data collection, he or she will sign the Informed Consent Form.
The data that will be collected are part of the standard clinical data. No additional investigations, blood tests or any other tests will be performed. We will collect the following data:
- Demographical information: gender, year of birth
- Relevant medical history: vascular risk profile, neurological history, psychiatric history, pre-stroke modified Rankin Score (mRS), home medication
- Neurological evaluation upon admission to Emergency Department: vital parameters, clinical neurological evaluation, results imaging
- Data concerning acute stroke therapy: intravenous thrombolysis, intra-arterial thrombectomy, medication started at the Emergency Department, neurosurgical procedures if performed, (neurological) evaluation after treatment
- Course of hospitalisation: complications (neurological deterioration, epilepsy, infections, falls, speech or swallow disturbances, thrombo-embolic complications, pain, cardiac complications), start of medication, treatment (such as physiotherapy, occupational therapy), date of discharge, mRS and NIHSS score at discharge, care after discharge
- Results stroke-investigations: imaging of brain and neck vessels, telemetry, Holter monitoring, transthoracic and/or transesophageal ultrasound, blood workup, electro-encephalographic investigations, genetic workup, etiology of stroke
- Therapy at discharge: medication, revalidation
- mRS score during follow-up at policlinic neurology
The purpose of this database is to conduct retrospective observational research in the future and will allow the hospital to keep track of some important quality indicators in stroke care.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients admitted to the Stroke unit (or to any other hospital ward) with a cerebrovascular disease and who have given their informed consent for data collection (or whose legal representative has given informed consent for data collection).
Key inclusion criteria (3 listed)
- Patients admitted to the Stroke unit with a cerebrovascular disease
- Patients admitted to the regular neurological ward or any other department in the University Hospital Ghent with a cerebrovascular disease who are actively followed by the department of Neurology during hospitalisation
- Patients who have given their explicit informed consent for data collection
Key exclusion criteria (2 listed)
- Patients who have not given informed consent for data collection
- Patients who are not able to give informed consent and whose legal representative has not given informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characteristics of study population
Time frame: date of inclusion until end of follow-up (12 months)
Information about patients included in the stroke database: age, gender, medical/family history
Onset-to-door
Time frame: date of inclusiondate of inclusion until end of follow-up (12 months)
Time between stroke onset and arrival at Emergency Department
Patients treated with acute stroke therapy
Time frame: date of inclusion until end of follow-up (12 months)
Patients treated with acute stroke therapy (i.e. thrombolysis and/or thrombectomy), start time of acute therapy
Outcome after acute therapy
Time frame: date of inclusion until end of follow-up (12 months)
Outcome after acute therapy, assessed by NIHSS and mRS score, possible complications and imaging
Incidence of complications at stroke unit
Time frame: date of inclusion until end of follow-up (12 months)
Incidence of neurological complications, epilepsy, infections, falls, thrombo-embolic complications, cardiac complications, pain
Etiology of stroke
Time frame: date of inclusion until end of follow-up (12 months)
Etiology of stroke, with a distinction between ischaemic stroke, hemorrhagic stroke, subarachnoid stroke or other
Mortality and disability after admission to Stroke unit
Time frame: date of discharge until end of follow-up (12 months)
Mortality and (severity of) disability after admission to stroke unit
1 secondary outcome
Quality of stroke care
Time frame: date of inclusion until end of follow-up (12 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: No
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
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 Stroke and Stroke, Acute, run by University Hospital, Ghent at 1 site in Belgium.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 15 Jan 2025. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Veerle De Herdt, MD PhD (+3293326481, veerle.deherdt@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characteristics of study population (time frame: date of inclusion until end of follow-up (12 months)). The study lists 7 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 15 Jan 2025.