StrokeSWISSNCT00108940
Siblings With Ischemic Stroke Study
An observational study of Stroke, run by Mayo Clinic at 32 sites in 2 countries.
Trial summary
The purpose of this study is to find the genes that increase the risk of developing an ischemic stroke using DNA samples collected from concordant (stroke-affected) sibling pairs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 900 participants
- Where
- 32 sitesin 2 countries
- Study dates
- Dec 2000to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: in-patient or out-patient clinics, local community
Who may be able to join
- Subject diagnosed by a study neurologist as having had a symptomatic ischemic stroke in the past.
- Head Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) done within 7 days of symptom onset confirms absence of etiology other than ischemic stroke.
- Subject reports having at least one living sibling with a stroke.
- Subject is 18 years of age or older.
Who cannot join
- The index ischemic stroke occurred within 48 hours after a cardiovascular or cerebrovascular procedure.
- The index ischemic stroke occurred within 60 days after a non-traumatic subarachnoid hemorrhage.
- The subject has brain biopsy-proven central nervous system vasculitis.
- The subject is known to have any one of the following genetic disorders: CADASIL (Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy), Fabry's disease, homocystinuria, MELAS (Mitochondrial myopathy, Encephalopathy, Lactic Acidosis, Stroke), or sickle cell anemia.
- The subject has a mechanical aortic valve or mechanical mitral valve.
- The subject had untreated or actively treated bacterial endocarditis at the time of the index ischemic stroke.
Trial locations and contacts
32 sites in 2 countries.
32 sites in 2 countries
United States30 sites
University of Maryland
Baltimore, Maryland, 21201
East Bay Region Assoc.
Berkeley, California, 94705
University of Virginia
Charlottesville, Virginia, 22908
University of Cincinnati
Cincinnati, Ohio, 45267-0525
Metro Health
Cleveland, Ohio, 44109
Ohio State University
Columbus, Ohio, 43210
Luther Midelfort Clinic
Eau Claire, Wisconsin, 54703
St. Mary's Medical Center
Huntington, West Virginia, 25702
Indiana University/Clarian Health Partners
Indianapolis, Indiana, 46202
Shands Jacksonville
Jacksonville, Florida, 32209
Mayo Clinic College of Medicine Jacksonville
Jacksonville, Florida, 32224
Scripps Clinic
La Jolla, California, 92039
University of Wisconsin, Madison
Madison, Wisconsin, 53792
Froedtert Memorial Lutheran
Milwaukee, Wisconsin, 53226
University of South Alabama
Mobile, Alabama, 36617
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
OSF St. Francis Medical Center
Peoria, Illinois, 61637
University of Penn. Med. Center
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Mayo Clinic
Rochester, Minnesota, 55905
Rochester General Hospital
Rochester, New York
University of California, Davis
Sacramento, California, 95817
Mercy General Hospital
Sacramento, California, 95819
Mayo Clinic Arizona
Scottsdale, Arizona, 85054
Mercy Medical Center
Sioux City, Iowa, 51101
Washington University School of Medicine
St Louis, Missouri, 63110
Florida Neurovascular Institute
Tampa, Florida, 33606
Helen Hayes Hospital
West Haverstraw, New York, 10994
Cleveland Clinic - Florida
Weston, Florida, 33331
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
Canada2 sites
Hospital Charles Le Moyne
Greenfield Park, Quebec, J4V2H1
L'Enfant-Jesus Hospital
Québec, Quebec
About this study
The purpose of this study is to find the genes that increase the risk of developing an ischemic stroke using DNA samples collected from concordant (stroke-affected) sibling pairs.
Read the detailed description
Stroke is the third leading cause of death in the United States and a leading cause of acquired disability in adults. Each year, about 700,000 people experience stroke in the country. Ischemic stroke, which constitutes about 80 percent of all strokes, is a complex genetic disorder--the result of interactions between multiple genes and multiple environmental exposures. Genes affecting cholesterol, blood pressure, clotting, and other factors may increase the risk of ischemic stroke.
In this clinical study, investigators are studying groups of siblings in which at least two of the siblings have had an ischemic stroke. The goal of this multi-center study is to find the genes that increase the risk of developing an ischemic stroke.
To accomplish the aims of the study, researchers are using DNA samples collected from concordant (stroke-affected) sibling pairs to determine if there are regions in the human genome associated with ischemic stroke or that may harbor stroke susceptibility genes.
Two teaspoons of blood will be collected from each participant and submitted for genetic analysis. Understanding the genetic predisposition to stroke could have major benefits for public health.
- Conditions
- Stroke
- Keywords
- stroke, ischemic stroke, siblings
- Medical subject headings
- Stroke, Ischemic Stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2005 (estimated)
- Study startDec 2000
- Primary completionJun 2009
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- James F. Meschia, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00108940
- Sponsor's protocol ID
- 1082-99
- Other IDs
- R01NS039987
- Acronym
- SWISS
- Status last verified
- Sep 2011
- First submitted
- 20 Apr 2005
- Last updated
- 27 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Siblings With Ischemic Stroke Study
- ClinicalTrials.gov ID
- NCT00108940
- Acronym / sponsor ID
- SWISS / 1082-99
- Conditions
- Stroke
- Keywords
- stroke, ischemic stroke, siblings
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Dec 2000
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 21 Apr 2005 (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 find the genes that increase the risk of developing an ischemic stroke using DNA samples collected from concordant (stroke-affected) sibling pairs.
Detailed description
Stroke is the third leading cause of death in the United States and a leading cause of acquired disability in adults. Each year, about 700,000 people experience stroke in the country. Ischemic stroke, which constitutes about 80 percent of all strokes, is a complex genetic disorder--the result of interactions between multiple genes and multiple environmental exposures. Genes affecting cholesterol, blood pressure, clotting, and other factors may increase the risk of ischemic stroke.
In this clinical study, investigators are studying groups of siblings in which at least two of the siblings have had an ischemic stroke. The goal of this multi-center study is to find the genes that increase the risk of developing an ischemic stroke.
To accomplish the aims of the study, researchers are using DNA samples collected from concordant (stroke-affected) sibling pairs to determine if there are regions in the human genome associated with ischemic stroke or that may harbor stroke susceptibility genes.
Two teaspoons of blood will be collected from each participant and submitted for genetic analysis. Understanding the genetic predisposition to stroke could have major benefits for public health.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- in-patient or out-patient clinics, local community
Key inclusion criteria (4 listed)
- Subject diagnosed by a study neurologist as having had a symptomatic ischemic stroke in the past.
- Head Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) done within 7 days of symptom onset confirms absence of etiology other than ischemic stroke.
- Subject reports having at least one living sibling with a stroke.
- Subject is 18 years of age or older.
Key exclusion criteria (6 listed)
- The index ischemic stroke occurred within 48 hours after a cardiovascular or cerebrovascular procedure.
- The index ischemic stroke occurred within 60 days after a non-traumatic subarachnoid hemorrhage.
- The subject has brain biopsy-proven central nervous system vasculitis.
- The subject is known to have any one of the following genetic disorders: CADASIL (Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy), Fabry's disease, homocystinuria, MELAS (Mitochondrial myopathy, Encephalopathy, Lactic Acidosis, Stroke), or sickle cell anemia.
- The subject has a mechanical aortic valve or mechanical mitral valve.
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2011.
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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. This study is not recruiting at the moment.
James F. Meschia, M.D. principal investigator
Mayo Clinic
32 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Mayo Clinic at 32 sites in 2 countries.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 27 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 27 Sep 2011.