Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001368
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Potential Risk Factors for Stroke
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Cytokine and Leukocyte Activation Profile as a Risk Factor for Cerebral Vascular Disease and Stroke
Status:
COMPLETED
Status Verified Date:
2002-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Early studies have shown that the immune system may play a role in the development of strokes Conditions such as high blood pressure high cholesterol diabetes and old age can activate the immune system and increase the risk of developing hardening of the arteries atherosclerosis and damaged blood vessels
Researchers will attempt to characterize factors that may contribute to atherosclerosis and stroke by measuring certain components of the immune system cytokines and leukocyte activation Measurements will be taken from patients that are considered to be stroke prone and from patients without risk factors for the development of stroke Researchers will measure the immune system components at the beginning of the study at six months and at the one-year completion of the study
The study will attempt to determine
I If patients with risk factors for stroke have an increased activation of the immune system
II If patients with risk factors for stroke that are symptomatic have higher levels of immune system activation compared to patients who do not have symptoms
III If patients with increased activation of the immune system have accelerated hardening of the arteries atherosclerosis
Researchers will attempt to characterize factors that may contribute to atherosclerosis and stroke by measuring certain components of the immune system cytokines and leukocyte activation Measurements will be taken from patients that are considered to be stroke prone and from patients without risk factors for the development of stroke Researchers will measure the immune system components at the beginning of the study at six months and at the one-year completion of the study
The study will attempt to determine
I If patients with risk factors for stroke have an increased activation of the immune system
II If patients with risk factors for stroke that are symptomatic have higher levels of immune system activation compared to patients who do not have symptoms
III If patients with increased activation of the immune system have accelerated hardening of the arteries atherosclerosis
Detailed Description:
Preliminary studies indicate that activation of the immune system by risk factors for stroke hypertension hypercholesterolemia diabetes and age increases the risk of atherosclerosis and the formation of intravascular thrombosis By measuring the levels of cytokine and leukocyte activation in the stroke prone population and age matched controls without risk factors an attempt will be made to characterize those factors which potentially increase the risk for carotid atherosclerosis and subsequent cerebral infarctions
A total of one hundred twenty subjects with risk factors for stroke and forty controls will be enrolled over a two year period and followed for one year All subjects will have blood drawn at the time of enrollment at six months and one year to measure cytokine levels including Interleukin-I Tumor Necrosis Factor-Alpha Interleukin-8 and leukocyte activationreceptor including Intercellular Adhesion Molecule-1 ICAM-1 Endothelial Leukocyte Adhesion Molecule-1 ELAM-1 V-Cell Adhesion Molecule VCAM and Macrophage Antigen-1 Carotid dopplers will be performed at the time of enrollment and at one year
An analysis will be performed to 1 determine if patients with risk factors for stroke have an increased activation of baseline cytokine levels and leukocytes 2 determine if patients who have stroke risk factors and are symptomatic have an increased activation of cytokines and leukocyte vs asymptomatic patients and 3 determine if patients with increased cytokineleukocyte activity have accelerated atherosclerosis of the carotid arteries
A total of one hundred twenty subjects with risk factors for stroke and forty controls will be enrolled over a two year period and followed for one year All subjects will have blood drawn at the time of enrollment at six months and one year to measure cytokine levels including Interleukin-I Tumor Necrosis Factor-Alpha Interleukin-8 and leukocyte activationreceptor including Intercellular Adhesion Molecule-1 ICAM-1 Endothelial Leukocyte Adhesion Molecule-1 ELAM-1 V-Cell Adhesion Molecule VCAM and Macrophage Antigen-1 Carotid dopplers will be performed at the time of enrollment and at one year
An analysis will be performed to 1 determine if patients with risk factors for stroke have an increased activation of baseline cytokine levels and leukocytes 2 determine if patients who have stroke risk factors and are symptomatic have an increased activation of cytokines and leukocyte vs asymptomatic patients and 3 determine if patients with increased cytokineleukocyte activity have accelerated atherosclerosis of the carotid arteries
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 93-N-0220 | None | None | None |