View Clinical Trial (Medical Research Study)
TIA Triage Trial and Evaluation of Vascular-Specific Inflammatory BiomarkerLp-PLA2 as a Stratification Tool for TIA Triage and Stroke Risk
| City: |
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Grand Rapids |
| State: |
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Michigan |
| Zip Code: |
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49503 |
| Conditions: |
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Cerebrovascular Accident |
| Purpose: |
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Transient ischemic attack (TIA) is a transient neurological deficit (speech disturbance,
weakness…), caused by temporary occlusion of a brain vessel by a blood clot that leaves no
lasting effect.
TIA diagnosis can be challenging and an expert stroke evaluation combined with magnetic
resonance imaging (MRI) could improve the diagnosis accuracy.
The risk of a debilitating stroke can be as high as 5% during the first 72 hrs after TIA.
TIA characteristics (duration, type of symptoms, age of the patient), the presence of a
significant narrowing of the neck vessels responsible for the patient's symptoms
(symptomatic stenosis), and an abnormal MRI are associated with an increased risk of stroke.
An emergent evaluation and treatment of TIA patients by a stroke specialist could reduce the
risk of stroke to 2%.
Stanford has implemented an expedited triage pathway for TIA patients combining a clinical
evaluation by a stroke neurologist, an acute MRI of the brain and the vessels and a sampling
of biomarkers (Lp-PLA2). The investigators are investigating the yield of this unique
approach to improve TIA diagnosis, prognosis and secondary stroke prevention. The objective
of this prospective cohort study is to determine which factors will help the physician to
confirm the diagnosis of TIA and to define the risk of stroke after a TIA.
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| Study Summary: |
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Patients with a clinical suspicion of TIA seen at the Stanford Emergency Department, will be
admitted to the Clinical Decision Area (CDA). The CDA is a short duration (<24 hrs))
hospitalization unit, where the patient can receive expedited evaluation and monitoring in a
more comfortable setting than in the ED. Patients will be evaluated by a neurologist
(resident with fellow or stroke attending). Clinical information will be collected in a
dedicated chart.
Evaluation:
As recommended by the AHA, in the absence of contraindications, all the patients will
undergo an MRI of the brain and a neck vessel evaluation as part of standard care. This exam
will be obtained within 6 hours after patient admission to the emergency department. The
diffusion sequence of the brain MRI will detect the presence of an acute injury related to a
blood clot (ischemic injury), and the perfusion sequence will capture abnormal
intra-cerebral blood flow. The other sequences will exclude the presence of other brain
lesions susceptible to explain the transient symptoms presented by the patient. The MR
angiogram (MRA) of the neck and intracranial vessels will detect the presence of a
symptomatic stenosis that would require emergent treatment. In case of MRI contraindication,
the patient will undergo a CT of the head and neck combining neck and intracranial vessel
evaluation and perfusion imaging.
As recommended, patients will get an EKG and a cardiovascular examination as part of routine
care.
As recommended, patients will get a standard lab evaluation as part of routine care
including general chemistry, hematology, coagulation, lipid profile, Hb A1C), and if
indicated, a specific prothrombotic and an inflammatory evaluation.
In approximately 100 patients - AS PART OF THIS RESEARCH PROTOCOL - the investigators will
evaluate the level of the lipoprotein A2 L at one time point. This biomarker has been
associated in one publication with an increased risk of vascular events among TIA patients.
After informed consent, the investigators will perform a standard venipuncture to draw 10 mL
of blood per patient. The blood will be collected in serum gel separator tubes. The serum
will be kept cold, and separated from gel and cells within 2 hours. The specimens will then
be frozen down at -70C until analyses performed by diaDexus lab who are sponsoring this part
of the study.
- As part of the routine triage pathway, patients with an initial normal clinical,
radiological and biological evaluation are evaluated within the next 12 hours by an
attending stroke neurologist who will determine whether the patient could be safely
discharged from the hospital, and the treatment plan including risk factors management
and antithrombotic treatment. This treatment is initiated in the hospital before
patient discharge. In following these guidelines, the majority of patients are
hospitalized for less than 24 hours.
- As part of the routine triage pathway, all patients are seen by a stroke neurologist
and/or a stroke trained nurse practitioner within the next 2 weeks at the Stanford
outpatient TIA clinic. All the patients routinely receive a follow up telephone call at
1 month, 3 months and 1 year to evaluate the occurrence of a stroke a myocardial
infarction and/or a vascular death. In some instances, one or more of these visits is
clinically indicated to be an in-person visit. If this is the case, the data from the
in-person clinic visit will be used as part of this study rather than a telephone
visit.
The clinical characteristics of the TIA, the radiological results, the biological results
and the follow up information will be collected and used in this research protocol for all
the consented patients.
The investigators will include all patients who were evaluated under this new pathway since
it's inception in January 2010. This patient population will be included as chart reviews.
The charts will be reviewed and data points extracted from the medical record to be used as
part of the research.
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| Criteria: |
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Inclusion Criteria:
- Men and Women age greater than 18 year old
- Symptoms suggestive of an acute TIA
Exclusion Criteria:
- Patients with contraindication to brain imaging: MRI and CT.
- Patient with persistent major deficit (NIHSS> or = 4)
- Informed consent could not be obtained either directly from the patient or from
legally authorized representative.
- Severe coexisting or terminal systemic disease with like expectancy below 90 days or
that may interfere with the conduct of the study.
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| NCT ID: |
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NCT01423201 |
| Primary Contact: |
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Principal Investigator
Gregory W Albers
Stanford University
Stephanie Kemp, BS
Phone: (650) 723-4481
Email: skemp@stanford.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Grand Rapids, Michigan 49503
United States
Michael Brown, MD
Phone: 616-391-3050
Email: brownm@msu.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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