Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT00009243 |
| Other study ID # |
010007 |
| Secondary ID |
01-N-0007 |
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 26, 2001 |
Study information
| Verified date |
May 6, 2024 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
Meghan M Hildreth |
| Phone |
(301) 435-2269 |
| Email |
meghan.hildreth[@]nih.gov |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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, and/or 12
months, when some of these tests may be repeated to assess changes over time
Description:
Study Description:
This is a natural history/disease 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.
