Natural History of Stroke: Cause and Development

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-120
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged >=18

Presented to participating study site (ED, ICU, or inpatient unit) with or at risk of acute stroke, TIA, or other disturbances of cerebrovascular circulation

Disqualifiers

Central nervous system aneurysm clips

Implanted neural stimulator

Implanted cardiac pacemaker or defibrillator

Cochlear implant

Trial population

Subjects are recruited from the collaborative stroke programs between NINDS and affiliated hospitals (Suburban Hospital and MedStar Washington Hospital Center) and will be followed for the duration of their hospitalization. Select subjects will then be seen for follow up for up to one year.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

4,000 Participants
are grouped into 1 trial group
Group A: Patients

Trial outcomes

Primary outcomes

1

Prevalence and type of abnormalities seen on neuroimaging as a function of time from acute insult

Neuroimaging abnormalities, such as:-Imaging positive for acute ischemic cerebral vascular syndrome ( AICS positive )-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"-The evolution of these markers with time and treatment

Time frame
Post-acute, 24 hours, 5 days/discharge, 30 days

Secondary outcomes

1

Stroke severity as measured by NIHSS as a function of time since index event

Time frame
Post-acute, 24 hours, 5 days/discharge, 30 days, 3 months, 6 months, 12 months
2

Clinical outcome measured using modified Rankin Scale and Barthel Index

Time frame
5 days/discharge, 30 days, 3 months, 6 months, 12 months
3

Gene expression profiles and biomarker levels obtained from blood samples

Time frame
Post-acute, 24 hours, 5 days/discharge, 30 days, 3 months, 6 months, 12 months

Other outcomes

Sponsors and contacts

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