[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT00009243":3,"trial-entities:NCT00009243":133,"trial-summary:NCT00009243":137},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":9,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":23,"study_type":30,"primary_purpose":9,"phases":31,"enrollment_info":32,"interventions":35,"primary_outcomes":36,"secondary_outcomes":41,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":53,"eligibility_criteria":54,"std_ages":66,"locations":69,"central_contacts":105,"overall_officials":112,"references":115,"see_also_links":129},"NCT00009243","010007","Natural History of Stroke: Cause and Development","Evaluation, Pathogenesis, and Treatment of Patients With or at Risk for Cerebrovascular Disease (A Natural History\u002FDisease Pathogenesis Protocol)","RECRUITING",null,"2026-08-25","2026-08-27","2001-01-26","National Institute of Neurological Disorders and Stroke (NINDS)","NIH","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.\n\nPatients 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.\n\nThe 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:\n\n* Blood and urine tests not more than 2 tablespoons of blood will be drawn for various tests.\n* Electrocardiogram (EKG) (heart tracing)-electrodes placed on the chest wall detect the heartbeat and heart rhythm.\n* Computed tomography (CT) scan of the head-specialized X-rays are used to obtain images of the brain.\n* 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.\n* Transcranial Doppler (TCD)-sound waves are used to image the arteries of the brain and neck.\n* Echocardiogram-sound waves are used to image the heart and evaluate heart function.\n\nPatients may be asked to return to Suburban Hospital for follow-up testing in 1, 3, and\u002For 12 months, when some of these tests may be repeated to assess changes over time","Study Description:\n\nThis is a natural history\u002Fdisease 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.\n\nObjectives:\n\n* 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.\n* To characterize the natural history of acute stroke, TIA, and other disturbances of cerebrovascular circulation on these variables.\n* To evaluate the relationship among these variables by exploratory analyses and to generate hypotheses for future testing.\n* To identify potential subjects for research studies on stroke and other cerebrovascular diseases.\n\nEndpoints:\n\nA 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.\n\nPrimary Outcome Measures\n\nPrevalence and type of abnormalities seen on neuroimaging as a function of time from acute insult such as:\n\n* Imaging positive for acute ischemic cerebral vascular syndrome ( AICS positive )\\[1\\]\n* Presence of a lesion on diffusion, perfusion, and mismatch between the two\n* Evidence of a vascular occlusion on MR angiography\n* Evidence of a thrombus or hemorrhage on T2\\* GRE imaging\n* Blood-brain barrier disruption as evidence by HARM \\[2\\]\n* The evolution of these markers with time and treatment\n\nSecondary Outcome Measures\n\n* Stroke severity as measured by NIHSS as a function of time since index event.\n* Clinical outcome measured using modified Rankin Scale and Barthel Index\n* Gene expression profiles and biomarker levels obtained from blood samples.",[18,19,20,21,22],"Brain Disease","Ischemic Attack, Transient","Cerebrovascular Accident","Cerebrovascular Disorder","Vascular Diseases",[24,25,26,27,28,29],"Stroke","Natural History","MRI (Magnetic Resonance Imaging)","Magnetic Resonance Imaging","Acute Stroke","TIA","OBSERVATIONAL",[],{"count":33,"type":34},4000,"ESTIMATED",[],[37],{"measure":38,"description":39,"timeFrame":40},"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\u002Fdischarge, 30 days",[42,45,48],{"measure":43,"timeFrame":44},"Stroke severity as measured by NIHSS as a function of time since index event","Post-acute, 24 hours, 5 days\u002Fdischarge, 30 days, 3 months, 6 months, 12 months",{"measure":46,"timeFrame":47},"Clinical outcome measured using modified Rankin Scale and Barthel Index","5 days\u002Fdischarge, 30 days, 3 months, 6 months, 12 months",{"measure":49,"timeFrame":44},"Gene expression profiles and biomarker levels obtained from blood samples","ALL","18 Years","120 Years",false,{"inclusion":55,"exclusion":56,"raw_text":65},[],[57,58,59,60,61,62,63,64],"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","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Aged \\>=18\n2. Presented to participating study site (ED, ICU, or inpatient unit) with or at risk of acute stroke, TIA, or other disturbances of cerebrovascular circulation\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. 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:\n\n   * Central nervous system aneurysm clips\n   * Implanted neural stimulator\n   * Implanted cardiac pacemaker or defibrillator\n   * Cochlear implant\n   * Ocular foreign body (e.g. metal shavings)\n   * Insulin pump\n   * Metal shrapnel or bullet\n   * Any implanted device that is incompatible with MRI\n\n   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.\n2. Pregnancy",[67,68],"ADULT","OLDER_ADULT",[70,85,95],{"facility":71,"status":8,"city":72,"state":73,"zip":74,"country":75,"contacts":76,"geoPoint":82},"Medstar Washington Hospital Center","Washington D.C.","District of Columbia","20010","United States",[77],{"name":78,"role":79,"phone":80,"email":81},"Lawrence Latour, Ph.D.","CONTACT","301-435-2395","latourl@ninds.nih.gov",{"lat":83,"lon":84},38.89511,-77.03637,{"facility":86,"status":8,"city":87,"state":88,"zip":89,"country":75,"contacts":90,"geoPoint":92},"Suburban Hospital - Johns Hopkins Medicine","Bethesda","Maryland","20814",[91],{"name":78,"role":79,"phone":80,"email":81},{"lat":93,"lon":94},38.98067,-77.10026,{"facility":96,"status":8,"city":87,"state":88,"zip":97,"country":75,"contacts":98,"geoPoint":104},"National Institutes of Health Clinical Center","20892",[99],{"name":100,"role":79,"phone":101,"phoneExt":102,"email":103},"For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)","800-411-1222","TTY dial 711","ccopr@nih.gov",{"lat":93,"lon":94},[106,110],{"name":107,"role":79,"phone":108,"email":109},"Nicole L Peterkin","(301) 435-2395","nicole.peterkin@nih.gov",{"name":111,"role":79,"phone":108,"email":81},"Lawrence L Latour, Ph.D.",[113],{"name":111,"affiliation":13,"role":114},"PRINCIPAL_INVESTIGATOR",[116,120,123,126],{"pmid":117,"type":118,"citation":119},"40436255","DERIVED","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\u002Fj.jstrokecerebrovasdis.2025.108358. Epub 2025 May 26.",{"pmid":121,"type":118,"citation":122},"35264400","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\u002Fsvn-2021-001224. Epub 2022 Mar 9.",{"pmid":124,"type":118,"citation":125},"31238832","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\u002FSTROKEAHA.119.025914. Epub 2019 Jun 26.",{"pmid":127,"type":118,"citation":128},"31238830","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\u002FSTROKEAHA.119.025784. Epub 2019 Jun 26.",[130],{"label":131,"url":132},"NIH Clinical Center Detailed Web Page","https:\u002F\u002Fclinicalstudies.info.nih.gov\u002Fcgi\u002Fdetail.cgi?A_2001-N-0007.html",{"nct_id":4,"conditions":134,"biomarkers":136},[21,24,135],"Transient Ischemic Attack",[],{"nct_id":4,"found":138,"summary":139,"prompt_version":149},true,{"design":140,"status":141,"heading":142,"summary":143,"follow_up":144,"word_count":145,"commitments":146,"compensation":147,"drugs_mentioned":148},"This is an observational study with a planned enrollment of 4000 participants. It is not testing a specific intervention or drug.","completed","Observational Study on the Natural History of Stroke","This study aims to better understand stroke and related conditions like Transient Ischemic Attacks (TIAs), which are temporary stroke-like symptoms. Researchers are observing how these conditions develop over time. They will collect information from patients to create a registry and identify patterns in stroke and TIA. This information will help researchers develop new ideas for future studies. You may be eligible if you are 18 or older and have experienced or are at risk of a stroke or TIA, and are seen at Suburban Hospital's emergency department or inpatient units.","The study will look at brain imaging results at post-acute, 24 hours, 5 days\u002Fdischarge, and 30 days after the initial event.",90,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]