Clinical trial NCT04956185: Data Collection of Patients Admitted to the Stroke Unit
Official title: Prospective Data Collection of Patients Admitted to the Stroke Unit At University Hospital Ghent
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Stroke, Acute
Stroke, Ischemic
Stroke Hemorrhagic
Stroke Sequelae
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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).

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Characteristics of study population
timeFrame: date of inclusion until end of follow-up (12 months)
measure: Onset-to-door
timeFrame: date of inclusiondate of inclusion until end of follow-up (12 months)
measure: Patients treated with acute stroke therapy
timeFrame: date of inclusion until end of follow-up (12 months)
measure: Outcome after acute therapy
timeFrame: date of inclusion until end of follow-up (12 months)
measure: Incidence of complications at stroke unit
timeFrame: date of inclusion until end of follow-up (12 months)
measure: Etiology of stroke
timeFrame: date of inclusion until end of follow-up (12 months)
measure: Mortality and disability after admission to Stroke unit
timeFrame: date of discharge until end of follow-up (12 months)
Secondary outcomes:
measure: Quality of stroke care
timeFrame: date of inclusion until end of follow-up (12 months)
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Department of Neurology - Ghent University Hospital
state: Flanders
Study officials:
References: