Acute Stroke Clinical Trial
Official title:
Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) in Work up for i.v. Thrombolysis: a Single-centre Study
Verified date | May 2016 |
Source | Bispebjerg Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Ethics Committee |
Study type | Interventional |
Acute stroke occurs in approximately 13.000 persons every year in Denmark, 10 - 15 % now
receives intervenous thrombolytic therapy, which remains the most important acute treatment
in ischaemic stroke. For more than a decade there has been an ongoing discussion if
Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) were best before
thrombolysis: Magnetic Resonance Imaging is superior in visualising ischaemia, but
Computerized Tomography is quicker and more easily applicable.
In the investigators centre primary imaging in work up of acute stroke during working hours
will alternate between Computerized Tomography and Magnetic Resonance Imaging days based on
a fixed calendar for a 24 months period as a quality development project.
This study is planned to include patients who have acute stroke imagining during this
period, a total of 600 patients is expected. The investigators will compare door-to-needle
time, patient safety, quality of imaging, patients' experience, physicians' decision
certainty, and use of recourses.
Status | Completed |
Enrollment | 499 |
Est. completion date | January 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Clinical suspicion of stroke <4.5 hours - National Institute of Health Stroke Scale (NIHSS) = 1 - Admission to Bispebjerg University Hospital (Copenhagen, Denmark) on even days in the daytime - Informed consent by patient or proxy Exclusion Criteria: - Patients in whom the stroke diagnosis is refuted on arrival - Patients not providing informed consent |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Neurology, Bispebjerg University Hospital | Copenhagen | Copenhagen (NV) |
Lead Sponsor | Collaborator |
---|---|
Bispebjerg Hospital | TRYG Foundation |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Stroke Physicians' treatment certainty of prescribing or refraining from intravenous Tissue-Plasminogen-Activator in patients with symptoms of acute stroke | Comparison of mean Visual Analogue Scale scores (measured in millimeters) assessing the stroke physicians' treatment certainty of prescribing or refraining from intravenous tissue-Plaminogen-Activator to patients with symptoms of acute stroke | First day of hospitalization | No |
Primary | Identification of contraindications to administration of intravenous tissue-Plasminogen-Activator to patients with symptoms of acute stroke | Observed frequency of primary Intracranial Hemorrhage and Intracranial tumors on first day of admission in patients with symptoms of acute stroke examined with Computer Tomography versus Magnetic Resonance Imaging | First day of hospitalization | Yes |
Secondary | Time from admission to administration of intravenous tissue-Plasminogen-Activator for patients examined with Computer Tomography versus Magnetic Resonance Imaging | Comparison of median time in minutes from admission to administration of intravenous Tissue-Plasminogen-Activator for patients examined with Computer Tomography versus Magnetic Resonance Imaging | First day of hospitalization | No |
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