Procoagulant Effects of Hyperglycemia After Acute Stroke: A Pilot Study

NCT00373269 | Completed Results

• 1 other identifier: 3866 4187
• Study Type: observational
• Target: 21
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ischemic Stroke; Hyperglycemia

Keywords

Acute ischemic stroke; Stroke; Hyperglycemia; Procoagulation; Diabetes; Blood coagulation

Outcome Measures

Primary Outcomes (1)

• FVIIa

  FVIIa levels were compared between the normoglycemic and hyperglycemic subjects.

  Baseline

Secondary Outcomes (1)

• TF-PCA

  Baseline

Study Arms (2)

Diabetic subject

Subjects with acute stroke, hyperglycemia and history of diabetes.

Normoglycemic Control

Subjects with acute stroke and normal blood glucose.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the Emergency Department with acute ischemic stroke within 12 hours of onset of symptoms.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Temple University: lead

MeSH Terms

Conditions

Ischemic Stroke; Hyperglycemia; Stroke; Diabetes Mellitus; Thrombosis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Embolism and Thrombosis

Results Point of Contact

• Title: Dr. Nina T. Gentile
• Organization: Temple University

ngentile@temple.edu

215-707-8402

Study Officials

• Nina T Gentile, MD

  Temple University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2006
• First Posted: September 8, 2006
• Study Start: October 1, 2001
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: February 27, 2017
• Results First Posted: January 4, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share