StrokeI-SPOTNCT01811550
Study of Procoagulation Markers in Stroke Patients
An observational study of Stroke and Hyperglycemia, run by Temple University at 38 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hyperglycemia, Procoagulation Markers
- How many people
- 271 participants
- Where
- 38 sitesUnited States
- Study dates
- Aug 2012to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be selected from participants in the SHINE trial.
Who may be able to join
- Enrolled in SHINE study
- Ability to give Informed Consent (self or LAR)
Who cannot join
- Current or planned use of full dose anticoagulation from baseline to the 48 hour sample collection
- 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)
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
Abington Memorial Hospital
Abington, Pennsylvania, 19001
Summa Health System
Akron, Ohio, 44304
Emory University Hospital
Atlanta, Georgia, 30322
Grady Memorial Hospital
Atlanta, Georgia, 30322
Augusta University
Augusta, Georgia, 30912
Massachusetts General Hospital
Boston, Massachusetts, 02114
Kings County Hospital
Brooklyn, New York, 11203
SUNY Downstate University Hospital of Brooklyn
Brooklyn, New York, 11203
Kaleida Stroke Center, SUNY Buffalo
Buffalo, New York, 14210
University of Virginia
Charlottesville, Virginia, 22908
University of Cincinnati
Cincinnati, Ohio, 45221
Wexner Medical Center
Columbus, Ohio, 43210
UT Southwestern-Parkland Memorial Hospital
Dallas, Texas, 75390
UT Southwestern-Zale Lipshy University Hospital
Dallas, Texas, 75390
Detroit Receiving Hospital
Detroit, Michigan, 48201
Sinai-Grace Hospital
Detroit, Michigan, 48235
Memorial Hermann Hospital
Houston, Texas, 77030
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
University of Kentucky
Lexington, Kentucky, 40506
Long Beach Memorial Hospital
Long Beach, California, 90806
Ronald Regan Medical Center
Los Angeles, California, 90095
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, 55455
West Virginia University
Morgantown, West Virginia, 26506
Mount Sinai Medical Center
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
Lincoln Medical and Mental Health Center
New York, New York, 10451
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Temple University Hospital
Philadelphia, Pennsylvania, 19140
UPMC - Mercy
Pittsburgh, Pennsylvania, 15219
UPMC - Presbyterian
Pittsburgh, Pennsylvania, 15261
University of Utah
Salt Lake City, Utah, 84132
San Francisco General Hospital
San Francisco, California, 94110
Stanford University Medical Center
Stanford, California, 94305
Banner University Medical Center
Tucson, Arizona, 85724
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Insights on Selected Procoagulation Markers and Outcomes in Stroke Trial (I-SPOT)
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.
Read more
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.
- Conditions
- Stroke, Hyperglycemia, Procoagulation Markers
- Being tested
- Glycemic Control
- Medical subject headings
- Stroke, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycemic ControlOther
Also called Blood draw at 0 and 48 hours, Glycemic Control per SHINE protocol
| Study group | Role | What they receive |
|---|---|---|
| SHINE study subjects | Subjects enrolled in the SHINE trial who are not receiving intra-arterial therapy 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. Receives: Other: Glycemic Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in biomarker between patients with favorable versus unfavorable functional outcome
Measured: Randomization, 48 hours and 90 days
Secondary outcomes (1)
Changes in biomarker levels between patients with versus without stroke recurrence at 90 days post stroke.
Measured: Randomization, 48 hours, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2013 (estimated)
- Study startAug 2012
- Primary completionOct 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Neurological Emergencies Treatment Trials Network (NETT), University of Virginia, University of Michigan, Medical University of South Carolina, Augusta University
- Responsible party
- Sponsor
- Investigators
- Nina T Gentile, M.D., Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811550
- Sponsor's protocol ID
- 11110979
- Other IDs
- 1U01NS079077-01A1
- Acronym
- I-SPOT
- Status last verified
- Apr 2020
- First submitted
- 12 Mar 2013
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insights on Selected Procoagulation Markers and Outcomes in Stroke Trial (I-SPOT)
- ClinicalTrials.gov ID
- NCT01811550
- Acronym / sponsor ID
- I-SPOT / 11110979
- Conditions
- Stroke, Hyperglycemia, Procoagulation Markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Neurological Emergencies Treatment Trials Network (NETT), University of Virginia, University of Michigan, Medical University of South Carolina, Augusta University
- Study start
- Aug 2012
- Primary completion
- Oct 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 14 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHINE study subjects | – | Other: Glycemic ControlSubjects enrolled in the SHINE trial who are not receiving intra-arterial therapy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be selected from participants in the SHINE trial.
Key inclusion criteria (2 listed)
- Enrolled in SHINE study
- Ability to give Informed Consent (self or LAR)
Key exclusion criteria (3 listed)
- Current or planned use of full dose anticoagulation from baseline to the 48 hour sample collection
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glycemic ControlAlso: Blood draw at 0 and 48 hours, Glycemic Control per SHINE protocol | Other | SHINE study subjects |
Primary outcome
change in biomarker between patients with favorable versus unfavorable functional outcome
Time frame: Randomization, 48 hours and 90 days
1 secondary outcome
Changes in biomarker levels between patients with versus without stroke recurrence at 90 days post stroke.
Time frame: Randomization, 48 hours, 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina T Gentile, M.D. principal investigator
Temple University
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Hyperglycemia, run by Temple University at 38 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in biomarker between patients with favorable versus unfavorable functional outcome (time frame: Randomization, 48 hours and 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2020.