Study of Procoagulation Markers in Stroke Patients (I-SPOT)
This study is currently recruiting participants.
Verified February 2013 by Temple University
Sponsor:
Temple University
Collaborators:
SHINE Trial
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: March 18, 2013
Last verified: February 2013
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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 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:
|
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 subjects participating 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01811550
Hide Study Locations
Contacts
| Contact: Hannah Reimer, RN, BSN | 215-707-5483 | hreimer@temple.edu |
Hide Study LocationsLocations
| United States, California | |
| Ronald Regan Medical Center | Not yet recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Ileana Grunberg igrunberg@mednet.ucla.edu | |
| Principal Investigator: Sidney Starkman, MD | |
| Stanford University Medical Center | Not yet recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Ryan Snider rsnider@stanford.edu | |
| Principal Investigator: James Quinn, MD | |
| United States, Florida | |
| Mayo Clinic Jacksonville | Not yet recruiting |
| Jacksonville, Florida, United States, 32224 | |
| Contact: Sothear Luke luke.sothear@mayo.edu | |
| Principal Investigator: Kevin Barrett, MD | |
| United States, Georgia | |
| Grady Memorial Hospital | Not yet recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Alex Hall alex.hall@emory.edu | |
| Principal Investigator: Vishal Patel, MD | |
| Georgia Health Sciences University | Not yet recruiting |
| Augusta, Georgia, United States, 30912 | |
| Contact: Brian Close bclose@georgiahealth.edu | |
| Principal Investigator: Askiel Bruno, 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, Massachusetts | |
| Massachusetts General Hospital | Not yet recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Eric Riklin eriklin@partners.org | |
| Principal Investigator: Chris Anderson, MD | |
| United States, Michigan | |
| Henry Ford Hospital | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Anne Marie Lundell ALUNDEL1@hfhs.org | |
| Principal Investigator: Chris Lewandowski, MD | |
| Detroit Receiving Hospital | Not yet 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 | |
| Sinai-Grace Hospital | Not yet recruiting |
| Detroit, Michigan, United States, 48235 | |
| Contact: Valerie Mika vmika@med.wayne.edu | |
| Principal Investigator: Robert Welch, MD | |
| William Beaumont Hospital-Royal Oak | Not yet recruiting |
| Royal Oak, Michigan, United States, 48073 | |
| Contact: Megan Hausler Megan.Hausler@beaumont.edu | |
| Principal Investigator: Robert Swor, DO | |
| William Beaumont Hospital-Troy | Not yet recruiting |
| Troy, Michigan, United States, 48085 | |
| Contact: Blerina Shaqiri blerina.shaqiri@beaumont.edu | |
| Principal Investigator: Aveh Bastani, MD | |
| United States, Minnesota | |
| University of Minnesota Medical Center, Fairview | Not yet recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Julie Scherber JScherber@yahoo.com | |
| Principal Investigator: Mustapha Ezzeddine, MD | |
| Hennepin County Medical Center | Not yet recruiting |
| Minneapolis, Minnesota, United States, 55415 | |
| Contact: Julie Scherber JScherber@yahoo.com | |
| Principal Investigator: Mustapha Ezzeddine, MD | |
| United States, New Jersey | |
| Hackensack University Medical Center | Not yet recruiting |
| Hackensack, New Jersey, United States, 07601 | |
| Contact: Gordon Huie GHuie@HackensackUMC.org | |
| Principal Investigator: Joseph Feldman, MD | |
| United States, New York | |
| Kings County Hospital | Not yet recruiting |
| Brooklyn, New York, United States, 11203 | |
| Contact: Sarah Zelonis sarah.zelonis@downstate.edu | |
| Principal Investigator: Jennifer Martindale, MD | |
| Lincoln Medical and Mental Health Center | Not yet recruiting |
| New York, New York, United States, 10451 | |
| Contact: Colette Nyajure Colette.Nyajure@nychhc.org | |
| Principal Investigator: Steven Levine, MD | |
| Columbia University Medical Center | Not yet recruiting |
| New York, New York, United States, 10032 | |
| Contact: Cristina Falo maf9135@nyp.org | |
| Principal Investigator: Stephan Mayer, MD | |
| NYP Weill Cornell Medical Center | Not yet recruiting |
| New York, New York, United States, 10065 | |
| Contact: Entila Xhori enx9001@nyp.org | |
| Principal Investigator: Halinder Mangat, MD | |
| United States, Ohio | |
| University of Cincinnati | Recruiting |
| Cincinnati, Ohio, United States, 45221 | |
| Contact: Irene Ewing ewingi@ucmail.uc.edu | |
| Principal Investigator: Opeolu Adeoye, MD | |
| Wexner Medical Center | Not yet recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: April Spangler April.Spangler@osumc.edu | |
| Principal Investigator: Michel Torbey, MD | |
| United States, Pennsylvania | |
| Abington Memorial Hospital | Not yet recruiting |
| Abington, Pennsylvania, United States, 19001 | |
| Contact: David Weisman dcweisman@gmail.com | |
| Principal Investigator: David Weisman, 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. | |
| Hospital of the University of Pennsylvania | Not yet recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Melissa Kruszewski ssa.kruszewski@uphs.upenn.edu | |
| Principal Investigator: Brett Cucchiara, MD | |
| Jefferson Hospital | Not yet recruiting |
| Philadelphia, Pennsylvania, United States, 19102 | |
| Contact: Jacqueline Urtecho Jacqueline.Urtecho@jefferson.edu | |
| Principal Investigator: Jacqueline Urtecho, MD | |
| Allegheny General Hospital | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| Contact: Melissa Tian MTIAN@wpahs.org | |
| Principal Investigator: Crystal Wong | |
| UPMC - Presbyterian | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15261 | |
| Contact: Sara DiFiore vandruffsm@upmc.edu | |
| Principal Investigator: Lori Shutter, MD | |
| United States, Texas | |
| UT Southwestern | Not yet 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 | Not yet recruiting |
| Salt Lake City, Utah, United States, 84132 | |
| Contact: Suyi Nui SUYI.NIU@hsc.utah.edu | |
| Principal Investigator: Jana Wold, MD | |
| United States, Wisconsin | |
| Froedtert Memorial Lutheran Hospital | Not yet recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Samantha Gauger sgauger@mcw.edu | |
| Principal Investigator: John Lynch, MD | |
| Aurora-St. Lukes Hospital | Not yet recruiting |
| Milwaukee, Wisconsin, United States, 53215 | |
| Contact: Tom Aufderheide, MD taufderh@mcw.edu | |
| Principal Investigator: Tom Aufderheide, MD | |
Sponsors and Collaborators
Temple University
SHINE Trial
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: | March 18, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Data and Safety Monitoring Board |
Additional relevant MeSH terms:
|
Hyperglycemia Stroke Cerebral Infarction Glucose Metabolism Disorders Metabolic Diseases Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 16, 2013