Data Collection of Patients Admitted to the Stroke Unit

NCT ID: NCT04956185

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-29
• Study Completion Date: 2031-02-01

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.

Conditions

Stroke; Stroke, Acute; Stroke, Ischemic; Stroke Hemorrhagic; Stroke Sequelae

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Neurology - Ghent University Hospital

Ghent, Flanders, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Veerle De Herdt, MD PhD

Role: CONTACT

veerle.deherdt@uzgent.be

+3293326481

Dimitri Hemelsoet, MD

Role: CONTACT

dimitri.hemelsoet@ugent.be

+3293325865

Facility Contacts

Veerle De Herdt, MD, PhD

Role: primary

Veerle.DeHerdt@ugent.be

+32-9-3324529

Other Identifiers

BC-09645

Identifier Type: -

Identifier Source: org_study_id