Brain DiseaseNCT00009243
Natural History of Stroke: Cause and Development
An observational study of Brain Disease and Ischemic Attack, Transient, run by National Institute of Neurological Disorders and Stroke (NINDS) at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Brain Disease, Ischemic Attack, Transient, Cerebrovascular Accident
- How many people
- 4,000 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Jan 2001to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Suburban Hospital - Johns Hopkins Medicine
Bethesda, Maryland, 20814
Lawrence Latour, Ph.D., 301-435-2395, latourl@ninds.nih.gov
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
- Recruiting
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Lawrence Latour, Ph.D., 301-435-2395, latourl@ninds.nih.gov
About this study
Official title: Evaluation, Pathogenesis, and Treatment of Patients With or at Risk for Cerebrovascular Disease (A Natural History/Disease Pathogenesis Protocol)
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.
Read more
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
Read the 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:
- 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.
- To characterize the natural history of acute stroke, TIA, and other disturbances of cerebrovascular circulation on these variables.
- To evaluate the relationship among these variables by exploratory analyses and to generate hypotheses for future testing.
- 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.
- 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
- Medical subject headings
- Brain Diseases, Ischemic Attack, Transient, Stroke, Cerebrovascular Disorders, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with acute stroke symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 5 days/discharge, 30 days, 3 months, 6 months, 12 months
Gene expression profiles and biomarker levels obtained from blood samples
Measured: Post-acute, 24 hours, 5 days/discharge, 30 days, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2001 (estimated)
- Study start26 Jan 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Brain DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lawrence L Latour, Ph.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00009243
- Sponsor's protocol ID
- 010007
- Other IDs
- 01-N-0007
- Status last verified
- 14 Oct 2026
- First submitted
- 24 Jan 2001
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data that underlie the results reported in the publication, after deidentification.
Publications
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.
PubMed 40436255Cho 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.
PubMed 35264400Luby 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.
PubMed 31238832Hsia 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.
PubMed 31238830
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation, Pathogenesis, and Treatment of Patients With or at Risk for Cerebrovascular Disease (A Natural History/Disease Pathogenesis Protocol)
- ClinicalTrials.gov ID
- NCT00009243
- Acronym / sponsor ID
- 010007
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 26 Jan 2001 (actual)
- First posted
- 25 Jan 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- 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.
- To characterize the natural history of acute stroke, TIA, and other disturbances of cerebrovascular circulation on these variables.
- To evaluate the relationship among these variables by exploratory analyses and to generate hypotheses for future testing.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients with acute stroke symptoms |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Derived from this study: PubMed 40436255Lomahan 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.
- Derived from this study: PubMed 35264400Cho 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.
- Derived from this study: PubMed 31238832Luby 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.
- Derived from this study: PubMed 31238830Hsia 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual Participant Data that underlie the results reported in the publication, after deidentification.
Related trials for Brain Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lawrence L Latour, Ph.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Disease and Ischemic Attack, Transient, run by National Institute of Neurological Disorders and Stroke (NINDS) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole L Peterkin ((301) 435-2395, nicole.peterkin@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00009243, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.