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Natural History of Stroke: Cause and Development

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ClinicalTrials.gov Identifier: NCT00009243
Recruitment Status : Recruiting
First Posted : January 25, 2001
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Tracking Information
First Submitted Date January 24, 2001
First Posted Date January 25, 2001
Last Update Posted Date October 19, 2020
Actual Study Start Date January 26, 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: May 17, 2019)
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, 3 months, 6 months, 12 months ]
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
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: May 17, 2019)
  • 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 ]
  • Clinical outcome measured using modified Rankin Scale and Barthel Index [ Time Frame: 5 days/discharge, 30 days, 3 months, 6 months, 12 months ]
  • 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 ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Natural History of Stroke: Cause and Development
Official Title Evaluation, Pathogenesis, and Treatment of Patients With or at Risk for Cerebrovascular Disease (A Natural History/Disease Pathogenesis Protocol)
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

Detailed Description

OBJECTIVE: This is a natural history/disease pathogenesis protocol for evaluation of patients with or at risk for 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 manifestations and the relationship among clinical, hematologic, and radiologic variables, as well as identifying potential subjects for future studies on stroke and other cerebrovascular diseases.

STUDY POPULATIONS: Patients will be recruited from the collaborative stroke program between NINDS and affiliated hospitals and will be followed for the duration of their hospitalization. Select subjects will then be seen for follow for up to one year.

DESIGN: Clinical issues to be addressed will include disease manifestations, natural history, acute disease management, and psychological/behavioral impact of the disease. Because of the nature of acute cerebrovascular disease, it is important to note that the research performed under this protocol will not interfere with emergency clinical evaluation or treatment of subjects, as specified in the clinical care pathway in place for the standard care of stroke patients at participating hospitals. Due to the emergency nature of clinical evaluation and therapy for stroke patients, waiver of written informed consent in certain circumstances for minimal risk procedures during acute period (e.g., collecting extra tubes of blood during initial phlebotomy for emergency room blood tests) will be required when it is impossible to obtain consent prior to critical emergency treatment procedures that may change the values of the variables. Patients will not be treated with experimental therapies as part of this protocol. Data collected under this protocol may be shared with other NIH researchers and databases and the National Institutes of Neurological Disorders and Stroke (NINDS) Repository if the subject approves this option in the informed consent.

OUTCOME MEASURES: In addition to clinical, imaging and laboratory data that are part of routine clinical care of the patient, a variety of outcomes will be collected, e.g., infarct volume, clinical outcomes on NIH Stroke Scale, modified Rankin Score, Barthel Index, blood marker of inflammation, coagulation and gene expression. Statistical analysis plans will be developed as specific questions and hypotheses are generated.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Brain Disease
  • Ischemic Attack, Transient
  • Cerebrovascular Accident
  • Cerebrovascular Disorder
  • Vascular Diseases
Intervention Not Provided
Study Groups/Cohorts Patients
Patients with acute stroke symptoms
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 22, 2009)
3000
Original Enrollment
 (submitted: June 23, 2005)
2000
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria
  • INCLUSION CRITERIA:

    1. Age greater than 18

EXCLUSION CRITERIA:

  1. Patient is less than 18 years of age.
  2. Subjects with contraindication to MRI scanning will be excluded from any testing which involves the use of MRI. These contraindications include subjects with the following devices or conditions:

    1. Central nervous system aneurysm clips;
    2. Implanted neural stimulator;
    3. Implanted cardiac pacemaker or defibrillator;
    4. Cochlear implant;
    5. Ocular foreign body (e.g. metal shavings);
    6. Insulin pump;
    7. Metal shrapnel or bullet;
    8. Any implanted device that is incompatible with MRI.

    Subjects with a condition precluding entry into the scanner (e.g. morbid obesity, claustrophobia, etc.) will not be included in the MRI portion of this study. Pregnant women will be excluded from testing which involves the use of MRI.

  3. Subjects will be excluded from 7T imaging if they are at risk of aspiration or have any condition that may require precipitous removal from the scanner.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Mariam Afzal (301) 435-2269 mariam.afzal@nih.gov
Contact: Lawrence Latour, Ph.D. (301) 496-0463 latourl@ninds.nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00009243
Other Study ID Numbers 010007
01-N-0007
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
Study Sponsor National Institute of Neurological Disorders and Stroke (NINDS)
Collaborators Not Provided
Investigators
Principal Investigator: Lawrence Latour, Ph.D. National Institute of Neurological Disorders and Stroke (NINDS)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date May 18, 2020