Ischemic StrokeNCT00373269
Procoagulant Effects of Hyperglycemia After Acute Stroke: A Pilot Study
An observational study of Ischemic Stroke and Hyperglycemia, run by Temple University.
Trial summary
Between twenty and fifty percent of people who have acute stroke have hyperglycemia (high blood sugar) with it. The purpose of this study is to examine the relationships between diabetes mellitus, hyperglycemia,whole blood tissue factor procoagulant activity (TF-PCA) and plasma factorVIIa (FVIIa) in ten patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Hyperglycemia
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Oct 2001to Nov 2005
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Patients presenting to the Emergency Department with acute ischemic stroke within 12 hours of onset of symptoms.
Who may be able to join
- Patients aged > 18 years presenting to the Emergency Department with symptoms of acute ischemic stroke will be included for study.
- Acute stroke patients with normal blood glucose levels and patients with fingerstick blood glucose level of greater than or equal to 150 mg/dl will be eligible for study.
- Acute Stroke will be defined as an acute disturbance of cerebral function of presumed vascular origin causing a neurological deficit of less than 24 hours duration.
- Patients must have an NIH Stroke Scale Score of 4 to 23. Patients awakening with symptoms of stroke will be considered to have had their stroke at the time when last awake without symptoms.
Who cannot join
- Patients presenting after 24 hours of symptom onset. When the actual time of onset is unknown, the time when last observed to be symptom-free will be used.
- Patients with NIH scale of less than 4 or greater than 23.
- Complete or substantial resolution of symptoms before randomization.
- Patients with a previously disabling stroke (modified Rankin score > 3)
- Patients with other systemic disease such as infection (eg pneumonia, etc)
- Patients with hemorrhage visualized on CT.
- Patients who are unwilling or unable to give informed consent, or for whom a legally authorized representative is not able to consent.
- Pregnant patients.
About this study
Between twenty and fifty percent of people who have acute stroke have hyperglycemia (high blood sugar) with it. The purpose of this study is to examine the relationships between diabetes mellitus, hyperglycemia,whole blood tissue factor procoagulant activity (TF-PCA) and plasma factorVIIa (FVIIa) in ten patients with type 2 diabetes mellitus and 11 non-diabetic patients at baseline and 6, 12, 24, and 48 hours (h) after presentation for acute stroke.
Read the detailed description
The purpose of this study is to examine the relationships between diabetes mellitus, hyperglycemia,whole blood tissue factor procoagulant activity (TF-PCA) and plasma factorVIIa (FVIIa) in ten patients with type 2 diabetes mellitus and 11 non-diabetic patients at baseline and 6, 12, 24, and 48 hours (h) after presentation for acute stroke.
Patients presenting to the Emergency Department with ongoing stroke symptoms and neurologic deficit less than 24 hours (h) duration were screened for inclusion into the study. Stroke patients were grouped in terms of diabetes status as determined by past medical history. Stroke diagnosis was confirmed with brain magnetic resonance imaging (MRI). Clinical care, including the acute management ofstroke and hyperglycemia, was done at the discretion of the Neurology service not involved in the study.
- Conditions
- Ischemic Stroke, Hyperglycemia
- Keywords
- Acute ischemic stroke, Stroke, Hyperglycemia, Procoagulation, Diabetes, Blood coagulation
- Medical subject headings
- Ischemic Stroke, Hyperglycemia, Stroke, Diabetes Mellitus, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic subject | Subjects with acute stroke, hyperglycemia and history of diabetes. | |
| Normoglycemic Control | Subjects with acute stroke and normal blood glucose. |
What is being measured
The primary outcome is the main question the study is designed to answer.
FVIIa
FVIIa levels were compared between the normoglycemic and hyperglycemic subjects.
Measured: Baseline
Secondary outcomes (1)
TF-PCA
TF-PCA levels compared between normoglycemic and hyperglycemic subjects.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
- Study startOct 2001
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ischemic 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nina T Gentile, MD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373269
- Sponsor's protocol ID
- 3866 4187
- Status last verified
- Jan 2017
- First submitted
- 5 Sep 2006
- Last updated
- 27 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procoagulant Effects of Hyperglycemia After Acute Stroke: A Pilot Study
- ClinicalTrials.gov ID
- NCT00373269
- Acronym / sponsor ID
- 3866 4187
- Conditions
- Ischemic Stroke, Hyperglycemia
- Keywords
- Acute ischemic stroke, Stroke, Hyperglycemia, Procoagulation, Diabetes, Blood coagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- Oct 2001
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 8 Sep 2006 (estimated)
- Results
- Posted 4 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Between twenty and fifty percent of people who have acute stroke have hyperglycemia (high blood sugar) with it. The purpose of this study is to examine the relationships between diabetes mellitus, hyperglycemia,whole blood tissue factor procoagulant activity (TF-PCA) and plasma factorVIIa (FVIIa) in ten patients with type 2 diabetes mellitus and 11 non-diabetic patients at baseline and 6, 12, 24, and 48 hours (h) after presentation for acute stroke.
Detailed description
The purpose of this study is to examine the relationships between diabetes mellitus, hyperglycemia,whole blood tissue factor procoagulant activity (TF-PCA) and plasma factorVIIa (FVIIa) in ten patients with type 2 diabetes mellitus and 11 non-diabetic patients at baseline and 6, 12, 24, and 48 hours (h) after presentation for acute stroke.
Patients presenting to the Emergency Department with ongoing stroke symptoms and neurologic deficit less than 24 hours (h) duration were screened for inclusion into the study. Stroke patients were grouped in terms of diabetes status as determined by past medical history. Stroke diagnosis was confirmed with brain magnetic resonance imaging (MRI). Clinical care, including the acute management ofstroke and hyperglycemia, was done at the discretion of the Neurology service not involved in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic subject | – | –Subjects with acute stroke, hyperglycemia and history of diabetes. |
| Normoglycemic Control | – | –Subjects with acute stroke and normal blood glucose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the Emergency Department with acute ischemic stroke within 12 hours of onset of symptoms.
Key inclusion criteria (4 listed)
- Patients aged > 18 years presenting to the Emergency Department with symptoms of acute ischemic stroke will be included for study.
- Acute stroke patients with normal blood glucose levels and patients with fingerstick blood glucose level of greater than or equal to 150 mg/dl will be eligible for study.
- Acute Stroke will be defined as an acute disturbance of cerebral function of presumed vascular origin causing a neurological deficit of less than 24 hours duration.
- Patients must have an NIH Stroke Scale Score of 4 to 23. Patients awakening with symptoms of stroke will be considered to have had their stroke at the time when last awake without symptoms.
Key exclusion criteria (8 listed)
- Patients presenting after 24 hours of symptom onset. When the actual time of onset is unknown, the time when last observed to be symptom-free will be used.
- Patients with NIH scale of less than 4 or greater than 23.
- Complete or substantial resolution of symptoms before randomization.
- Patients with a previously disabling stroke (modified Rankin score > 3)
- Patients with other systemic disease such as infection (eg pneumonia, etc)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
FVIIa
Time frame: Baseline
FVIIa levels were compared between the normoglycemic and hyperglycemic subjects.
1 secondary outcome
TF-PCA
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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, MD principal investigator
Temple University
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Hyperglycemia, run by Temple University.
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 4 inclusion and 8 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 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 4 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
FVIIa (time frame: Baseline). 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 27 Feb 2017.