Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009243
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2001-01-24
Brief Title:
Natural History of Stroke Cause and Development
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation Pathogenesis and Treatment of Patients With or at Risk for Cerebrovascular Disease A Natural HistoryDisease Pathogenesis Protocol
Status:
RECRUITING
Status Verified Date:
2024-09-09
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:
The purpose of this study is to learn more about stroke and obtain information that may serve as the basis for future investigations It will 1 establish a registry of patients with cerebrovascular disease stroke 2 characterize the natural history of acute stroke and transient ischemic attacks TIA-an interruption of blood flow to the brain that causes stroke symptoms for a short period of time and 3 evaluate the data to generate ideas for future studies
Patients 18 years of age or older with suspected acute stroke or TIA may be eligible for this study Subjects will be recruited from patients who present with stroke at the emergency department of Suburban Hospital in Bethesda Maryland
The study will gather data collected from diagnostic and laboratory tests the patient undergoes as part of standard medical care including findings of medical and neurological examinations and other tests In addition studies will be done for research purposes only to gather data about stroke and TIA These may include the following
Blood and urine tests not more than 2 tablespoons of blood will be drawn for various tests
Electrocardiogram EKG heart tracing-electrodes placed on the chest wall detect the heartbeat and heart rhythm
Computed tomography CT scan of the head-specialized X-rays are used to obtain images of the brain
Magnetic resonance imaging MRI of the brain-a strong magnetic field and radio waves are used to produce images that provide information about the brain tissue and blood vessels
Transcranial Doppler TCD-sound waves are used to image the arteries of the brain and neck
Echocardiogram-sound waves are used to image the heart and evaluate heart function
Patients may be asked to return to Suburban Hospital for follow-up testing in 1 3 andor 12 months when some of these tests may be repeated to assess changes over time
Patients 18 years of age or older with suspected acute stroke or TIA may be eligible for this study Subjects will be recruited from patients who present with stroke at the emergency department of Suburban Hospital in Bethesda Maryland
The study will gather data collected from diagnostic and laboratory tests the patient undergoes as part of standard medical care including findings of medical and neurological examinations and other tests In addition studies will be done for research purposes only to gather data about stroke and TIA These may include the following
Blood and urine tests not more than 2 tablespoons of blood will be drawn for various tests
Electrocardiogram EKG heart tracing-electrodes placed on the chest wall detect the heartbeat and heart rhythm
Computed tomography CT scan of the head-specialized X-rays are used to obtain images of the brain
Magnetic resonance imaging MRI of the brain-a strong magnetic field and radio waves are used to produce images that provide information about the brain tissue and blood vessels
Transcranial Doppler TCD-sound waves are used to image the arteries of the brain and neck
Echocardiogram-sound waves are used to image the heart and evaluate heart function
Patients may be asked to return to Suburban Hospital for follow-up testing in 1 3 andor 12 months when some of these tests may be repeated to assess changes over time
Detailed Description:
Study Description
This is a natural historydisease pathogenesis protocol for evaluation of patients with or at risk of acute stroke transient ischemic attack TIA or other disturbances of cerebrovascular circulation The purpose of this protocol is to generate natural history data to serve as the basis for future hypothesis-driven protocols as well as to contribute to the clinical and physiological understanding of cerebrovascular disease through the description of disease manifestation and the relationship among clinical hematologic and radiologic variables as well as identifying potential subjects for future studies on stroke and other cerebrovascular diseases
Objectives
To establish a registry of subjects with cerebrovascular disease including clinical laboratory and radiological variables associated with hemorrhagic and ischemic stroke TIA and other disturbances of cerebrovascular circulation
To characterize the natural history of acute stroke TIA and other disturbances of cerebrovascular circulation on these variables
To evaluate the relationship among these variables by exploratory analyses and to generate hypotheses for future testing
To identify potential subjects for research studies on stroke and other cerebrovascular diseases
Endpoints
A primary purpose of this observational protocol is to discover and study new imaging biomarkers that are i relevant to the acute presentation and severity ii predictive of clinical outcome and iii are useful for stratifying the biological response as reflected in blood-biomarker and gene expression studies As such the primary outcome is the results from the imaging studies
Primary Outcome Measures
Prevalence and type of abnormalities seen on neuroimaging as a function of time from acute insult such as
Imaging positive for acute ischemic cerebral vascular syndrome AICS positive 1
Presence of a lesion on diffusion perfusion and mismatch between the two
Evidence of a vascular occlusion on MR angiography
Evidence of a thrombus or hemorrhage on T2 GRE imaging
Blood-brain barrier disruption as evidence by HARM 2
The evolution of these markers with time and treatment
Secondary Outcome Measures
Stroke severity as measured by NIHSS as a function of time since index event
Clinical outcome measured using modified Rankin Scale and Barthel Index
Gene expression profiles and biomarker levels obtained from blood samples
This is a natural historydisease pathogenesis protocol for evaluation of patients with or at risk of acute stroke transient ischemic attack TIA or other disturbances of cerebrovascular circulation The purpose of this protocol is to generate natural history data to serve as the basis for future hypothesis-driven protocols as well as to contribute to the clinical and physiological understanding of cerebrovascular disease through the description of disease manifestation and the relationship among clinical hematologic and radiologic variables as well as identifying potential subjects for future studies on stroke and other cerebrovascular diseases
Objectives
To establish a registry of subjects with cerebrovascular disease including clinical laboratory and radiological variables associated with hemorrhagic and ischemic stroke TIA and other disturbances of cerebrovascular circulation
To characterize the natural history of acute stroke TIA and other disturbances of cerebrovascular circulation on these variables
To evaluate the relationship among these variables by exploratory analyses and to generate hypotheses for future testing
To identify potential subjects for research studies on stroke and other cerebrovascular diseases
Endpoints
A primary purpose of this observational protocol is to discover and study new imaging biomarkers that are i relevant to the acute presentation and severity ii predictive of clinical outcome and iii are useful for stratifying the biological response as reflected in blood-biomarker and gene expression studies As such the primary outcome is the results from the imaging studies
Primary Outcome Measures
Prevalence and type of abnormalities seen on neuroimaging as a function of time from acute insult such as
Imaging positive for acute ischemic cerebral vascular syndrome AICS positive 1
Presence of a lesion on diffusion perfusion and mismatch between the two
Evidence of a vascular occlusion on MR angiography
Evidence of a thrombus or hemorrhage on T2 GRE imaging
Blood-brain barrier disruption as evidence by HARM 2
The evolution of these markers with time and treatment
Secondary Outcome Measures
Stroke severity as measured by NIHSS as a function of time since index event
Clinical outcome measured using modified Rankin Scale and Barthel Index
Gene expression profiles and biomarker levels obtained from blood samples
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 01-N-0007 | None | None | None |