Natural History of Stroke: Cause and Development

NCT00009243 | Recruiting

• 2 other identifiers: 01000701-N-0007
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 3

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, and/or 12 months, when some of these tests may be repeated to assess changes over time

Conditions

Brain Disease; Ischemic Attack, Transient; Cerebrovascular Accident; Cerebrovascular Disorder; Vascular Diseases

Keywords

Stroke; Natural History; MRI (Magnetic Resonance Imaging); Magnetic Resonance Imaging; Acute Stroke; TIA

Outcome Measures

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

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

Secondary Outcomes (3)

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

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

• Clinical outcome measured using modified Rankin Scale and Barthel Index

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

• Gene expression profiles and biomarker levels obtained from blood samples

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

Study Arms (1)

Patients

Patients with acute stroke symptoms

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• 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

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Subjects with contraindication to MRI scanning will be excluded from any testing which involves the use of MRI. The contraindications include subjects with the following devices or conditions:
• Central nervous system aneurysm clips
• Implanted neural stimulator
• Implanted cardiac pacemaker or defibrillator
• Cochlear implant
• Ocular foreign body (e.g. metal shavings)
• Insulin pump
• Metal shrapnel or bullet
• Any implanted device that is incompatible with MRI
• Subjects with a condition precluding entry in the scanner (e.g. morbid obesity, Claustrophobia, etc.) will not be included in the MRI portion of this study.
• Pregnancy

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (3)

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Suburban Hospital - Johns Hopkins Medicine

Bethesda, Maryland, 20814, United States

RECRUITING

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (4)

• Lomahan CA, Luby M, Kalarakis G, Hsia AW, Lynch JK, Nathani KP, Somani S, Thomas LC, Arnberg-Sandor F, Latour LL. Hyperemia detection on arterial spin labeling is associated with final infarct volume in stroke post-endovascular therapy. J Stroke Cerebrovasc Dis. 2025 Aug;34(8):108358. doi: 10.1016/j.jstrokecerebrovasdis.2025.108358. Epub 2025 May 26.

  PMID: 40436255 DERIVED

• Cho YE, Lee H, Bae HR, Kim H, Yun S, Vorn R, Cashion A, Rucker MJ, Afzal M, Latour L, Gill J. Circulating immune cell landscape in patients who had mild ischaemic stroke. Stroke Vasc Neurol. 2022 Aug;7(4):319-327. doi: 10.1136/svn-2021-001224. Epub 2022 Mar 9.

  PMID: 35264400 DERIVED

• Luby M, Hsia AW, Nadareishvili Z, Cullison K, Pednekar N, Adil MM, Latour LL. Frequency of Blood-Brain Barrier Disruption Post-Endovascular Therapy and Multiple Thrombectomy Passes in Acute Ischemic Stroke Patients. Stroke. 2019 Aug;50(8):2241-2244. doi: 10.1161/STROKEAHA.119.025914. Epub 2019 Jun 26.

  PMID: 31238832 DERIVED

• Hsia AW, Luby M, Cullison K, Burton S, Armonda R, Liu AH, Leigh R, Nadareishvili Z, Benson RT, Lynch JK, Latour LL. Rapid Apparent Diffusion Coefficient Evolution After Early Revascularization. Stroke. 2019 Aug;50(8):2086-2092. doi: 10.1161/STROKEAHA.119.025784. Epub 2019 Jun 26.

  PMID: 31238830 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Brain Diseases; Ischemic Attack, Transient; Stroke; Cerebrovascular Disorders; Vascular Diseases

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Cardiovascular Diseases

Study Officials

• Lawrence L Latour, Ph.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole L Peterkin

CONTACT

(301) 435-2395; nicole.peterkin@nih.gov

Lawrence L Latour, Ph.D.

CONTACT

(301) 435-2395; latourl@ninds.nih.gov

Study Design

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

Study Record Dates

• First Submitted: January 24, 2001
• First Posted: January 25, 2001
• Study Start: January 26, 2001
• Last Updated: April 1, 2026

Record last verified: 2026-03-26

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 5 years after article publication.
• Access Criteria: IPD will be shared with researchers who provide a methodologically sound proposal . Proposals should be sent to the corresponding author of the publication.

Locations

US (3)