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CT or MRI in Work up for i.v. Thrombolysis: a Single-centre Study

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ClinicalTrials.gov Identifier: NCT02780843
Recruitment Status : Completed
First Posted : May 24, 2016
Last Update Posted : May 24, 2016
Sponsor:
Collaborator:
TRYG Foundation
Information provided by (Responsible Party):
Hanne Christensen, Bispebjerg Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Acute Stroke Other: Computerized Tomography Other: Magnetic Resonance Imaging Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 499 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) in Work up for i.v. Thrombolysis: a Single-centre Study
Study Start Date : December 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Computerized Tomography
Patients will be examined with Computerized Tomography (CT) at admission
Other: Computerized Tomography
Standard Operational Plan at admission: CT and CT-angiography
Other Name: CT

Experimental: Magnetic Resonance Imaging
Patients will be examined with Magnetic Resonance Imaging (MRI) at admission
Other: Magnetic Resonance Imaging
Standard Operational Plan at admission: Diffusion Weighted Imaging (DWI), T2-FLAIR, Gradient and arterial Time-of Flight (TOF)
Other Name: MR




Primary Outcome Measures :
  1. Identification of contraindications to administration of intravenous tissue-Plasminogen-Activator to patients with symptoms of acute stroke [ Time Frame: First day of hospitalization ]
    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


Secondary Outcome Measures :
  1. Time from admission to administration of intravenous tissue-Plasminogen-Activator for patients examined with Computer Tomography versus Magnetic Resonance Imaging [ Time Frame: First day of hospitalization ]
    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


Other Outcome Measures:
  1. Stroke Physicians' treatment certainty of prescribing or refraining from intravenous Tissue-Plasminogen-Activator in patients with symptoms of acute stroke [ Time Frame: First day of hospitalization ]
    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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02780843


Locations
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Denmark
Department of Neurology, Bispebjerg University Hospital
Copenhagen, Copenhagen (NV), Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
TRYG Foundation
Investigators
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Study Chair: Hanne K Christensen, MD PhD DMSci Department of Neurology, Bispebjerg University Hospital

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Responsible Party: Hanne Christensen, MD, PhD, DMSci, FESO, Associate Research Professor, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT02780843     History of Changes
Other Study ID Numbers: H-4-2013-118
First Posted: May 24, 2016    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hanne Christensen, Bispebjerg Hospital:
Stroke
Tomography, X-Ray Computed
Magnetic Resonance Imaging
Thrombolytic Therapy

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases