Transient Ischemic Attack (TIA) Triage and Evaluation of Stroke Risk

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Stanford University
Sponsor:
Collaborators:
diaDexus, INC
University of California, Davis
Information provided by (Responsible Party):
Gregory W Albers, Stanford University
ClinicalTrials.gov Identifier:
NCT01423201
First received: August 16, 2011
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

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.


Condition
Cerebrovascular Accident

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: TIA Triage Trial and Evaluation of Vascular-Specific Inflammatory BiomarkerLp-PLA2 as a Stratification Tool for TIA Triage and Stroke Risk

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • vascular events [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vascular Events [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Vascular Events [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

First 100 cases:

2 tiger top or gold top tubes 2 lavender top tubes

  • Blood specimens should be inverted 10 times before processing.
  • Centrifuge and separate within four hours of venipuncture.
  • Transfer 1.0 ml into 2 transfer tubes

Freeze at -70 C

Additional 80 cases:

3 PAXgene tubes (total 16cc) - containing 7.5 cc preservative to stabilize RNA immediately.

Invert 20 times then sit at room temperature overnight Place into a -70C freezer until processed

2 tiger top or gold top tubes 2 lavender top tubes

  • Blood specimens should be inverted 10 times before processing.
  • Centrifuge and separate within four hours of venipuncture.
  • Transfer 1.0 ml into 2 transfer tubes

Freeze at -70 C


Estimated Enrollment: 400
Study Start Date: September 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients admitted to the ED with symptoms of acute TIA

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01423201

Contacts
Contact: Stephanie Kemp, BS (650) 723-4481 skemp@stanford.edu

Locations
United States, California
UC Davis Medical Center Active, not recruiting
Davis, California, United States
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Stephanie Kemp, BS    650-723-4481    skemp@stanford.edu   
Principal Investigator: Gregory W Albers         
Sub-Investigator: Waimei A Tai         
Sub-Investigator: Anna K. Finley Caulfield         
Sub-Investigator: Dr. chitra venkat         
Sub-Investigator: Maarten G Lansberg MD, PhD         
Sub-Investigator: Neil Schwartz         
Sub-Investigator: Jean-Marc Olivot         
Sub-Investigator: Karen Hirsch, MD         
Sub-Investigator: Nirali Vora, MD         
Sub-Investigator: Paul George, MD, PhD         
United States, Michigan
Michigan State University Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Michael Brown, MD    616-391-3050    brownm@msu.edu   
Principal Investigator: Michael Brown         
Sponsors and Collaborators
Stanford University
diaDexus, INC
University of California, Davis
Investigators
Principal Investigator: Gregory W Albers Stanford University
  More Information

Publications:
Responsible Party: Gregory W Albers, MD, Professor of Neurology, Stanford University
ClinicalTrials.gov Identifier: NCT01423201     History of Changes
Other Study ID Numbers: SU-08012011-8167, 19211
Study First Received: August 16, 2011
Last Updated: August 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
TIA
triage
Lp-PLA2
Proteomic
Genomic

Additional relevant MeSH terms:
Cerebral Infarction
Ischemic Attack, Transient
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014