Hyperglycemia, Ischemic Stroke
Conditions
Keywords
Acute ischemic stroke, Stroke, Hyperglycemia, Procoagulation, Diabetes, Blood coagulation
Brief 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 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.
Interventions
None listed
Sponsors
Temple University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FVIIa | Baseline | FVIIa levels were compared between the normoglycemic and hyperglycemic subjects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TF-PCA | Baseline | TF-PCA levels compared between normoglycemic and hyperglycemic subjects. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Normoglycemic Subjects with acute ischemic stroke and normal blood glucose. | 11 |
| Hyperglycemic Subjects with acute ischemic stroke and hyperglycemia. | 10 |
| Total | 21 |
Baseline characteristics
| Characteristic | Hyperglycemic | Normoglycemic | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 5 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 6 Participants | 13 Participants |
| Age, Continuous | 63.5 years STANDARD_DEVIATION 9.2 | 64.9 years STANDARD_DEVIATION 17.7 | 64.2 years STANDARD_DEVIATION 18.4 |
| Gender Female | 7 Participants | 5 Participants | 12 Participants |
| Gender Male | 3 Participants | 6 Participants | 9 Participants |
| Region of Enrollment United States | 10 Participants | 11 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
FVIIa
FVIIa levels were compared between the normoglycemic and hyperglycemic subjects.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normoglycemic Control | FVIIa | 69.7 mU/ml | Standard Deviation 33.3 |
| Hyperglycemic Subjects | FVIIa | 124.4 mU/ml | Standard Deviation 35.2 |
Secondary
TF-PCA
TF-PCA levels compared between normoglycemic and hyperglycemic subjects.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normoglycemic Control | TF-PCA | 183.5 U/ml | Standard Deviation 63.1 |
| Hyperglycemic Subjects | TF-PCA | 118.1 U/ml | Standard Deviation 56.9 |