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

NCT02780843 | Completed

• 1 other identifier: H-4-2013-118
• Study Type: interventional
• Target: 499
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Stroke

Keywords

Stroke; Tomography, X-Ray Computed; Magnetic Resonance Imaging; Thrombolytic Therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Time from admission to administration of intravenous tissue-Plasminogen-Activator for patients examined with Computer Tomography versus Magnetic Resonance Imaging

  First day of hospitalization

Other Outcomes (1)

• Stroke Physicians' treatment certainty of prescribing or refraining from intravenous Tissue-Plasminogen-Activator in patients with symptoms of acute stroke

  First day of hospitalization

Study Arms (2)

Computerized Tomography

EXPERIMENTAL

Patients will be examined with Computerized Tomography (CT) at admission

Other: Computerized Tomography

Magnetic Resonance Imaging

EXPERIMENTAL

Patients will be examined with Magnetic Resonance Imaging (MRI) at admission

Other: Magnetic Resonance Imaging

Interventions

Computerized Tomography OTHER

Standard Operational Plan at admission: CT and CT-angiography

Also known as: CT

Computerized Tomography

Magnetic Resonance Imaging OTHER

Standard Operational Plan at admission: Diffusion Weighted Imaging (DWI), T2-FLAIR, Gradient and arterial Time-of Flight (TOF)

Also known as: MR

Magnetic Resonance Imaging

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients in whom the stroke diagnosis is refuted on arrival
• Patients not providing informed consent

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• TRYG Foundation: collaborator

Study Sites (1)

Department of Neurology, Bispebjerg University Hospital

Copenhagen, Copenhagen (NV), 2400, Denmark

Location

MeSH Terms

Conditions

Stroke

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Hanne K Christensen, MD PhD DMSci

  Department of Neurology, Bispebjerg University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, DMSci, FESO, Associate Research Professor

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: May 24, 2016
• Study Start: December 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: May 24, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)