Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetic subject | Subjects with acute stroke, hyperglycemia and history of diabetes. | ||
| Normoglycemic Control | Subjects with acute stroke and normal blood glucose. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| FVIIa | FVIIa levels were compared between the normoglycemic and hyperglycemic subjects. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| TF-PCA | TF-PCA levels compared between normoglycemic and hyperglycemic subjects. | Baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients presenting to the Emergency Department with acute ischemic stroke within 12 hours of onset of symptoms.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nina T Gentile, MD | Temple University | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Normoglycemic Control | Subjects with acute ischemic stroke and normal blood glucose. |
| FG001 | Hyperglycemic Subjects | Subjects with acute ischemic stroke and hyperglycemia. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Normoglycemic | Subjects with acute ischemic stroke and normal blood glucose. |
| BG001 | Hyperglycemic | Subjects with acute ischemic stroke and hyperglycemia. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | FVIIa | FVIIa levels were compared between the normoglycemic and hyperglycemic subjects. | Posted | Mean | Standard Deviation | mU/ml | Baseline |
|
|
Not provided
Serious and Other (Not Including Serious) Adverse Events were not collected/assessed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diabetic Subject | Subjects with acute stroke, hyperglycemia and history of diabetes. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nina T. Gentile | Temple University | 215-707-8402 | ngentile@temple.edu |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D006943 | Hyperglycemia |
| D020521 | Stroke |
| D003920 | Diabetes Mellitus |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | TF-PCA | TF-PCA levels compared between normoglycemic and hyperglycemic subjects. | Posted | Mean | Standard Deviation | U/ml | Baseline |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Normoglycemic Control | Subjects with acute stroke and normal blood glucose. | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D016769 | Embolism and Thrombosis |