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
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.
Background: Stroke remains the third leading cause of death and the first leading cause of
handicap in adult age in high-income countries even now when causal revascularisation
therapy (intervenous (i.v) thrombolysis and endovascular therapy (EVT) has become generally
available. I.v. thrombolysis has been implemented as routine treatment within 4.5 hours of
symptom onset based on evidence from randomised controlled trials. Treatment benefit is
highly dependent on time from symptom onset to treatment and is therefore strongly related
to organisational issues including selection of imaging modality. I.v thrombolysis
registration was based on trials using non-contrast Computerized Tomography (CT). In,
general however, Magnetic Resonance Imaging (MRI) is considered to imply a higher standard
of care. MRI is considered to give more detailed information and improve patient safety. The
issue if CT or MRI is 'best' in i.v. thrombolysis work-up has been discussed by stroke
scientists for more than a decade, both nationally and internationally. MRI is superior in
detecting acute ischaemia and CT is quicker; but the effect of choice of imaging modality on
overall efficacy and safety remains to be determined in spite of completion of more than
74.000 i.v. thrombolysis treatments in Europe according to the SITS-MOST registry. Access to
primary work up by MRI is frequently regarded as a token of high treatment quality;
nevertheless, few centres worldwide are really primarily MRI based. CT is much faster and
has no contraindications. This may be crucial as the efficacy of thrombolysis decreases with
time to treatment - numbers needed to treat increases with 1 for every 20 minutes, making
the question if MRI is only of academic interest a relevant question.
The aim of this study is to determine if choice of primary imaging modality (CT vs MRI)
affects efficacy and safety of i.v. thrombolysis in open quasi-randomised design, where
imaging allocation was allocated based on the date of admission. The following items will be
compared:
1. Radiological exclusion of other causes of symptoms than acute cerebral ischemia
2. Contraindications to scanning method in terms of contrast and magnetism
3. Delay from admission to thrombolytic treatment in minutes
4. Radiological imaging of diagnostic quality
5. Identification of stroke mechanism according to TOAST classification
6. Visual Analogue Scale of patient experience of the admission radiological examination
7. Visual Analogue Scale of the treating physician's experience of decision support prior
to prescription of thrombolytic treatment
8. Deviation from radiological Standard Operational Plan
9. Time consumption for radiologists and radiographers in minutes
Method: Patients admitted with acute stroke during office hours and possibly also during
daytime in weekends in Bispebjerg University Hospital will be included into the study during
a 24 months study period. Based on activity in 2011, the investigators expect a study
population of 600 patients. Door to needle time is the parameter/endpoint strongest
associated with prognosis and therefore the most relevant from the patient's point of view.
This estimate is well within the planned sample size. However, the sample size is extended
in order to allow for analysis of less well-defined endpoints including patient experience.
- Study procedures: Patients are evaluated according to usual standard neurological
outcome (National Institute of Health Stroke Scale (NIHSS)) performed on admission and
on Day 1. Risk factors and co-morbidities are recorded and the stroke mechanism
evaluated. The patients or carers are contacted by telephone after approximately 3
months. Recurrence of stroke, Transient Ischemic Attack (TIA), Myocardial Infarction
(MI) and cardiac revascularization procedures are registered. If the patient is
diseased, time of death and cause of death will be extracted from patient files. The
functional outcome is assessed by the modified Rankin Scale (mRS) (including death).
- Patient experience of scan: The patient is asked day 1 about their experience of the
scanning procedure by use of visual analogue scales.
- The physicians' certainty of having made the right decision concerning thrombolysis:
The doctor notes by using a visual analogue scale (0-10) the strength of the clinical
decision to give or not give tissue Plasminogen Activator (tPA) immediately after the
bolus, or after the patient is informed that is not indicated.
- Resource use: Time from arrival until treatment initiation are recorded. Potential
deviation of resource consumption when derogating from the SOP will be accounted for.
- Data Analysis: Imaging is evaluated during the acute phase. Further, the diagnostic
imaging will be systematically and retrospectively evaluated by two senior
neuroradiological consultants that are blinded to clinical information except the side
of symptoms. X2-test, t-test/Mann-Whitney-test will be used depending on the
distribution of the material, as well as uni and multivariate logistic regression
analysis. It will be tested if the age, gender and severity affect the results. Data
relating to risk factors and co-morbidity will be used to characterize the patient
population. Function after 3 months expressed as mRS will be assessed, but the study
was not designed to be able to detect an eventual difference in level of functioning
after 3 months.
Ethical considerations: All patients are worked up according to best clinical practice and
in accordance with Danish, European and American guidelines. As study procedures are added
an interview on patient experience with the radiological procedure and a follow-up MRI,
which is not done in case of contraindications to MRI or at patient's request. Further data
on risk factors, the stroke event and follow up is recorded. There is no known risk related
to MRI in persons with no magnetic metal in the body (e.g. a pacemaker); this is excluded by
the same procedures as in clinical practice. The confined space and the noise of the
MRI-scanner may cause anxiety in some; this will be prevented and handled by experienced
radiographers as in clinical practice. Overall, there is no expected risks to participation
in the study and some chance of treatment benefit by additional follow-up MRI. The study may
have considerable impact on future treatment in patients with acute stroke as it may provide
clarification to which of the methods should be future primary strategy. Patient experience
as well as physicians experience is included in the analyses.
Economy: The study is fully financed by a grant from Tryg Fonden. The applicant and research
responsible has no other relations to the foundation.
Importance and relevance of the study: If the choice of imaging method significantly affects
predictors of good outcome after thrombolytic therapy initial use of the superior method
would lead to a benefit, which for the individual patient will correspond to less disability
after a stroke. Study results can be implemented directly in clinical practice; thought it
will be subject to an eventual need for revised allocation of resources even though the
total number of scans will not be affected. Based on the study's registration of resource
consumption, the health economic effects of the study can be estimated. Since stroke is a
very common and serious disorder, relatively minor improvements in the prognosis may have
noticeable effect on group or community level. Further, this study may close a long-standing
and sometimes emotional scientific discussion, setting as an example that trials remain the
only valid method of answering scientific questions. This set up with a research protocol
complementing a quality project enables us to evaluate this issue.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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