Study of Procoagulation Markers in Stroke Patients (I-SPOT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Temple University
Sponsor:
Collaborators:
Neurological Emergencies Treatment Trials Network (NETT)
University of Virginia
University of Michigan
Medical University of South Carolina
Georgia Regents University
Information provided by (Responsible Party):
Temple University
ClinicalTrials.gov Identifier:
NCT01811550
First received: March 12, 2013
Last updated: April 9, 2015
Last verified: April 2015
  Purpose

The Insights on Selected Procoagulation Markers and Outcomes in Stroke Trial (I-SPOT): Response to Insulin Administration and Blood Glucose Control proposal is designed to accompany the Stroke Hyperglycemia Insulin Network Effort (SHINE) clinical trial, a Phase III multicenter, randomized, controlled trial planning to determine the efficacy and validate the safety of glycemic control in stroke patients. The SHINE trial will recruit 1,400 AIS patients with Type II diabetes mellitus (T2DM) and hyperglycemia, each receiving 3 days of hyperglycemia control with intravenous (IV) insulin therapy or control therapy with subcutaneous (SQ) insulin. The I-SPOT trial will recruit 315 SHINE patients. Blood coagulation marker levels will be measured before and at 48 hours after the start of treatment. Baseline and temporal changes in biomarkers levels will be compared between treatment groups.

Hypothesis: The decrease in levels of markers of blood coagulation will be greater in patients treated with IV insulin to reduce BG than in patients treated with SQ Insulin as the standard fashion.

Hypothesis: The decrease in levels of markers of blood coagulation will be greater in patients with than without favorable (SHINE) outcome (defined as the baseline stroke severity adjusted measure of functional ability at 90 days after AIS).

Hypothesis: Hyperglycemia control modulates the relationship between blood coagulation levels and functional outcome in T2DM patients after stroke. Patients treated with IV Insulin for hyperglycemia control with favorable (SHINE) outcome will have greater decreases in blood coagulation levels than either IV Insulin-treated patients without favorable outcome or SQ Insulin-treated with or without favorable outcomes at 90 days after AIS.


Condition Intervention
Stroke
Hyperglycemia
Procoagulation Markers
Other: Glycemic Control

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Insights on Selected Procoagulation Markers and Outcomes in Stroke Trial (I-SPOT)

Resource links provided by NLM:


Further study details as provided by Temple University:

Primary Outcome Measures:
  • change in biomarker between patients with favorable versus unfavorable functional outcome [ Time Frame: Randomization, 48 hours and 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in biomarker levels between patients with versus without stroke recurrence at 90 days post stroke. [ Time Frame: Randomization, 48 hours, 90 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood and plasma


Estimated Enrollment: 315
Study Start Date: August 2012
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
SHINE study subjects
Subjects enrolled in the SHINE trial who are not recieving thrombolytics nor systemic anticoagulation; have no known moderate/severe hepatic insufficiency; have no known history of hypercoaguable or thrombotic condition; have INR =<1.5 (if known) at baseline and provide informed consent (self or LAR) will be enrolled in the I-SPOT study.
Other: Glycemic Control
Other Names:
  • Blood draw at 0 and 48 hours
  • Glycemic Control per SHINE protocol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects will be selected from participants in the SHINE trial.

Criteria

Inclusion Criteria:

  • Enrolled in SHINE study
  • Ability to give Informed Consent (self or LAR)

Exclusion Criteria:

  • Current or anticipated use of systemic anticoagulants or thrombolytics
  • Known moderate or severe hepatic insufficiency (as defined by INR>1.5 if known or history of variceal bleeding or hepatic encephalopathy)
  • Prior or concurrent thrombotic or hypercoagulable condition (Antiphospholipid antibody syndrome; Antithrombin III, Protein C or S deficiencies; Congenital or Inherited Factor deficiencies; sickle cell disease)
  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: NCT01811550

Contacts
Contact: Hannah Reimer, RN, BSN 215-707-5483 hreimer@temple.edu

  Hide Study Locations
Locations
United States, Arizona
University of Arizona Recruiting
Tuscon, Arizona, United States, 85724
Contact: Steve Triponey       striponey@aemrc.arizona.edu   
Principal Investigator: Kendra Drake, MD         
United States, California
Ronald Regan Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Ileana Grunberg       igrunberg@mednet.ucla.edu   
Principal Investigator: Sidney Starkman, MD         
San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
Contact: Michele Meeker       MeekerM@neurosurg.ucsf.edu   
Principal Investigator: Claude Hemphill, MD         
UCSF Medical Center Recruiting
San Francisco, California, United States, 94117
Contact: Michele Meeker       MeekerM@neurosurg.ucsf.edu   
Principal Investigator: Claude Hemphill, MD         
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Ryan Snider       rsnider@stanford.edu   
Principal Investigator: James Quinn, MD         
United States, Florida
Mayo Clinic Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Sothear Luke       luke.sothear@mayo.edu   
Principal Investigator: Kevin Barrett, MD         
United States, Georgia
Grady Memorial Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Alex Hall       alex.hall@emory.edu   
Principal Investigator: Vishal Patel, MD         
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Alex Hall       alex.hall@emory.edu   
Principal Investigator: Vishal Patel, MD         
Georgia Health Sciences University Recruiting
Augusta, Georgia, United States, 30912
Contact: Brian Close       bclose@georgiahealth.edu   
Principal Investigator: Askiel Bruno, MD         
United States, Illinois
Loyola University Chicago Not yet recruiting
Chicago, Illinois, United States, 60626
Contact: Jessica Ray       jeray@lumc.edu   
Principal Investigator: Tom Aufderheide, MD         
United States, Kansas
University of Kansas Hospital Recruiting
Kansas City, Kansas, United States, 66160
Contact: Shannon Guifford       sgifford@kumc.edu   
Principal Investigator: Michael Abraham, MD         
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40506
Contact: Linda Dechtenberg       ldech3@email.uky.edu   
Principal Investigator: Roger Humphries, MD         
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Charlene Aldrich       CALDRICH@smail.umaryland.edu   
Principal Investigator: Marcella Wozniak, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Eric Riklin       eriklin@partners.org   
Principal Investigator: Chris Anderson, MD         
Tufts Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02111
Contact: Michelle Bettle       MBettle@tuftsmedicalcenter.org   
Principal Investigator: Joshua Kornbluth, MD         
United States, Michigan
Detroit Receiving Hospital Recruiting
Detroit, Michigan, United States, 48201
Contact: Valerie Mika       vmika@med.wayne.edu   
Principal Investigator: Gregory Norris, MD         
Harper University Not yet recruiting
Detroit, Michigan, United States, 48201
Contact: Valerie Mika       vmika@med.wayne.edu   
Principal Investigator: Robert Welch, MD         
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Anne Marie Lundell       ALUNDEL1@hfhs.org   
Principal Investigator: Chris Lewandowski, MD         
Sinai-Grace Hospital Recruiting
Detroit, Michigan, United States, 48235
Contact: Valerie Mika       vmika@med.wayne.edu   
Principal Investigator: Robert Welch, MD         
William Beaumont Hospital-Royal Oak Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Megan Hausler       Megan.Hausler@beaumont.edu   
Principal Investigator: Robert Swor, DO         
William Beaumont Hospital-Troy Recruiting
Troy, Michigan, United States, 48085
Contact: Blerina Shaqiri       blerina.shaqiri@beaumont.edu   
Principal Investigator: Aveh Bastani, MD         
United States, Minnesota
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Julie Scherber       JScherber@yahoo.com   
Principal Investigator: Mustapha Ezzeddine, MD         
University of Minnesota Medical Center, Fairview Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Julie Scherber       JScherber@yahoo.com   
Principal Investigator: Mustapha Ezzeddine, MD         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Gordon Huie       GHuie@HackensackUMC.org   
Principal Investigator: Joseph Feldman, MD         
United States, New York
SUNY Downstate University Hospital of Brooklyn Recruiting
Brooklyn, New York, United States, 11203
Contact: Steven Levine, MD       Steven.Levine@downstate.edu   
Principal Investigator: Steven Levine, MD         
Kings County Hospital Recruiting
Brooklyn, New York, United States, 11203
Contact: Sarah Zelonis       sarah.zelonis@downstate.edu   
Principal Investigator: Jennifer Martindale, MD         
Kaleida Stroke Center, SUNY Buffalo Recruiting
Buffalo, New York, United States, 14210
Contact: Anne Marie Crumlish       ac35@buffalo.edu   
Principal Investigator: Marilou Ching, MD         
NYP Weill Cornell Medical Center Active, not recruiting
New York, New York, United States, 10065
Lincoln Medical and Mental Health Center Recruiting
New York, New York, United States, 10451
Contact: Colette Nyajure       Colette.Nyajure@nychhc.org   
Principal Investigator: Steven Levine, MD         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Cristina Falo       maf9135@nyp.org   
Principal Investigator: Jan Claassen, MD         
United States, Ohio
Summa Health System Recruiting
Akron, Ohio, United States, 44304
Contact: Rachelle Sharshu       scharsur@summahealth.org   
Principal Investigator: Susana Bowling, MD         
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45221
Contact: Irene Ewing       ewingi@ucmail.uc.edu   
Principal Investigator: Opeolu Adeoye, MD         
Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: April Spangler       April.Spangler@osumc.edu   
Principal Investigator: Michel Torbey, MD         
Miami Valley Hospital Not yet recruiting
Dayton, Ohio, United States, 45409
Contact: Angie Shoen       asshoen@premierhealth.com   
Principal Investigator: John Terry, MD         
United States, Oregon
Providence St. Vincent Medical Center Not yet recruiting
Portland, Oregon, United States, 97225
Contact: Monica Rodriguez, RN       monica.rodriguez@providence.org   
Principal Investigator: Archit Bhatt, MD         
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: David Weisman       dcweisman@gmail.com   
Principal Investigator: David Weisman, MD         
Penn State Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Deborah Hoffman       dhoffman1@hmc.psu.edu   
Principal Investigator: Kerstin Bettermann, MD         
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Melissa Kruszewski       ssa.kruszewski@uphs.upenn.edu   
Principal Investigator: Brett Cucchiara, MD         
Jefferson Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Jacqueline Urtecho       Jacqueline.Urtecho@jefferson.edu   
Principal Investigator: Jacqueline Urtecho, MD         
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Hannah Reimer, BSN    215-707-5483    hreimer@temple.edu   
Principal Investigator: Nina T Gentile, M.D.         
Allegheny General Hospital Withdrawn
Pittsburgh, Pennsylvania, United States, 15212
UPMC - Mercy Recruiting
Pittsburgh, Pennsylvania, United States, 15219
Contact: Sara DiFiore       vandruffsm@upmc.edu   
Principal Investigator: Lori Shutter, MD         
UPMC - Presbyterian Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Sara DiFiore       vandruffsm@upmc.edu   
Principal Investigator: Lori Shutter, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Diane Brown       diane.brown@vanderbilt.edu   
Principal Investigator: Howard Kirshner, MD         
United States, Texas
Austin Seton Medical Center Recruiting
Austin, Texas, United States, 78701
Contact: Heidi Tyler       HTyler@seton.org   
Principal Investigator: Steven Warach, MD         
Austin UMC Brackenridge Hospital Recruiting
Austin, Texas, United States, 78701
Contact: Heidi Tyler       HTyler@seton.org   
Principal Investigator: Steven Warach, MD         
UT Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Katrina van de Bruinhorst       Katrina.vandebruinhorst@utsouthwestern.edu   
Principal Investigator: Christiana Hall, MD, MS         
Memorial Hermann Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Monica Mendoza-Moore       monica.mendozamoore@uth.tmc.edu   
Principal Investigator: Elizabeth Jones, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Suyi Nui       SUYI.NIU@hsc.utah.edu   
Principal Investigator: Jana Wold, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Amy Fansler, MPH       acf7h@virginia.edu   
Principal Investigator: Karen Johnston, MD, MSc         
United States, West Virginia
West Virginia University Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Jay Sherman       shermanj@wvuhealthcare.com   
Principal Investigator: Todd Crocco, MD         
United States, Wisconsin
Aurora-St. Lukes Hospital Not yet recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Tom Aufderheide, MD       taufderh@mcw.edu   
Principal Investigator: Tom Aufderheide, MD         
Froedtert Memorial Lutheran Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Samantha Gauger       sgauger@mcw.edu   
Principal Investigator: John Lynch, MD         
Sponsors and Collaborators
Temple University
Neurological Emergencies Treatment Trials Network (NETT)
University of Virginia
University of Michigan
Medical University of South Carolina
Georgia Regents University
Investigators
Principal Investigator: Nina T Gentile, M.D. Temple University
  More Information

No publications provided

Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT01811550     History of Changes
Other Study ID Numbers: 11110979, 1U01NS079077-01A1
Study First Received: March 12, 2013
Last Updated: April 9, 2015
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Additional relevant MeSH terms:
Hyperglycemia
Stroke
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 01, 2015