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Natural History of Stroke: Cause and Development

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00009243
Recruitment Status : Recruiting
First Posted : January 25, 2001
Last Update Posted : November 22, 2022
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

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

...


Condition or disease
Brain Disease Ischemic Attack, Transient Cerebrovascular Accident Cerebrovascular Disorder Vascular Diseases

Detailed 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:

  1. 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.
  2. To characterize the natural history of acute stroke, TIA, and other disturbances of cerebrovascular circulation on these variables.
  3. To evaluate the relationship among these variables by exploratory analyses and to generate hypotheses for future testing.
  4. 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.

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation, Pathogenesis, and Treatment of Patients With or at Risk for Cerebrovascular Disease (A Natural History/Disease Pathogenesis Protocol)
Actual Study Start Date : January 26, 2001

Resource links provided by the National Library of Medicine


Group/Cohort
Patients
Patients with acute stroke symptoms



Primary Outcome Measures :
  1. Prevalence and type of abnormalities seen on neuroimaging as a function of time from acute insult [ Time Frame: Post-acute, 24 hours, 5 days/discharge, 30 days ]
    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


Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria
  • INCLUSION CRITERIA:

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

  1. Aged >=18
  2. Presented to participating study site (ED, ICU, or inpatient unit) with or at risk of acute stroke, TIA, or other disturbances of cerebrovascular circulation

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

  1. 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.

  2. Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00009243


Contacts
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Contact: Mariam Afzal (301) 435-2269 mariam.afzal@nih.gov
Contact: Lawrence Latour, Ph.D. (301) 496-0463 latourl@ninds.nih.gov

Locations
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United States, District of Columbia
Medstar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Mariam Afzal    240-281-9832    mariam.afzal@nih.gov   
United States, Maryland
Suburban Hospital - Johns Hopkins Medicine Recruiting
Bethesda, Maryland, United States, 20814
Contact: Mariam Afzal    240-281-9832    mariam.afzal@nih.gov   
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY dial 711    ccopr@nih.gov   
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Lawrence Latour, Ph.D. National Institute of Neurological Disorders and Stroke (NINDS)
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT00009243    
Other Study ID Numbers: 010007
01-N-0007
First Posted: January 25, 2001    Key Record Dates
Last Update Posted: November 22, 2022
Last Verified: November 16, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: .Individual Participant Data that underlie the results reported in the publication, after deidentification.
Supporting Materials: Study Protocol
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Stroke
Natural History
Magnetic Resonance Imaging
MRI (Magnetic Resonance Imaging)
Acute Stroke
TIA
Additional relevant MeSH terms:
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Stroke
Brain Diseases
Cerebrovascular Disorders
Ischemic Attack, Transient
Vascular Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Ischemia