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Stroke Interventions in Clinical Trials
Printable Version
SWISS
Siblings with Ischemic Stroke Study



Principal Investigator
James F. Meschia, MD

PI Address
Department of Neurology,
Mayo Clinic Jacksonville
4500 San Pablo Road
Jacksonville, Florida 32224

Contact Address
Alexa Richie
Clinical Research Coordinator
Mayo Clinic
Ph. (904) 953-7839
Email: Richie.alexa@mayo.edu

Contact Email
meschia.james@mayo.edu

Sponsor



Study Size Actual:678
Study Size Planned:800
Centers Actual:50
Centers Planned:50
Max Age:80
Min Age:18
ISRCTN#NCT00108940
Status:
This study is ongoing, but not recruiting participants.

Purpose:
To identify regions of the human genome that correlate with risk of developing ischemic stroke, by studying sibling pairs.

Location(s):
US, Canada

Year Started: 2000

Design:
Genome-wide screen using DNA obtained from concordant and discordant sibling pairs.

Inclusion Criteria
There will be three classes of participants-- probands, concordant siblings, and discordant siblings-- each with their own inclusion and exclusion criteria.

Probands must have at least one ischemic stroke episode confirmed by either head CT or MRI done completed 7 days of symptom onset. In addition they must have at least one living full sibling with a history of ischemic stroke. There is no time limit on how long ago the stroke may have occurred.

Concordant siblings must have at least one radiographically-verified ischemic stroke episode, in addition to one living full sibling enrolled as a proband in SWISS.

Discordant siblings must have no history of ischemic stroke, transient ischemic attack (TIA), or stroke symptoms, and must have at least two full siblings with a history of ischemic stroke who are enrolled in SWISS.

Exclusion Criteria
Patients whose strokes occurred within 48 hours of an invasive cerebrovascular or cardiovascular procedure, a catheter-based procedure on carotid or coronary arteries, carotid endarterectomy, heart valve surgery, or thoracic or thoracoabdominal aortic aneurysm repair, whose ischemic strokes occur within 60 days of nontraumatic subarachnoid hemorrhage (SAH), who have had brain-biopsy-proven central nervous system vasculitis at any time, who have Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL), Fabry disease, homocystinuria, mitochondrial encephalopathy with lactic acidosis and stroke-like episodes (MELAS), or sickle -cell anemia, or who had a mechanical aortic or mitral valve, or bacterial endocarditis at the time of stroke onset, will be excluded from the "Proband" and "Concordant Sibling" groups.

Patients who give a positive answer to any of the 8 questions on the Questionnaire for Verifying Stroke-Free Status (QVSFS), or who deemed unreliable historians by the study interviewer due to moderate or severe impairment of speech, language, hearing, or memory, will be excluded from the "Discordant Sibling" group.

Patient Involvement:
Probands: Prior to enrollment, patients' medical records and test results will be reviewed by a study neurologist to confirm the diagnosis of ischemic stroke. Eligible patients will be classified by stroke subtype, according to the TOAST criteria. Probands will then mail invitations to participate in SWISS to their siblings.

Discordant Siblings: Persons who respond positively to the SWISS invitation will be given the QSVS test and a brief medical history via telephone interview. Patients who receive a QSVS score > 0 will be considered for inclusion in the "Concordant Siblings" group.

Concordant Siblings: Persons who respond positively to the SWISS invitation will have their medical records requested and reviewed by investigators in order to verify stroke diagnosis.

Once an eligible proband has at least one verified concordant sibling, blood will be collected from all enrolled family members for genetic analysis by a home health care agency.

Primary Outcome:
Chromosomal regions correlated with ischemic stroke risk.

Comments:
DNA collection began October of 2000, and recruitment is ongoing. As of May 2008, genetic samples from 678 individuals from 280 pedigrees had been collected. 300 concordant sibling pairs and 200 discordant siblings at over 50 centers across North America are expected to participate.

Source of Information:
Presented at the 25th International Stroke Conference (February 2000). Stroke. 2002;33:646. Protocol published in BMC Medical Genetics, 2/02. Presented at the 28th International Stroke Conference (February 2003).

Web Links and Publications:
Candidate Gene Polymorphisms for Ischemic Stroke.
Stroke 2009 Sep 3;

Joint Commission primary stroke center certification does not affect proband enrollment: the siblings with ischemic stroke study.
J Stroke Cerebrovasc Dis 2009 Sep-Oct;18(5):363-6

Proband race/ethnicity affects pedigree completion rate in a genetic study of ischemic stroke.
J Stroke Cerebrovasc Dis 2008 Sep;17(5):299-302

Stroke genetic research and adults with impaired decision-making capacity: a survey of IRB and investigator practices.
Stroke 2008 Oct;39(10):2732-5

Association of integrin alpha2 gene variants with ischemic stroke.
J Cereb Blood Flow Metab 2008 Jan;28(1):81-9

Impact of restricting enrollment in stroke genetics research to adults able to provide informed consent.
Stroke 2008 Mar;39(3):831-7

ISC Abstract 77
STROKE

ISC Abstract 186
STROKE

Lack of aggregation of ischemic stroke subtypes within affected sibling pairs.
Neurology 2007 Feb 6;68(6):427-31

IL1RN VNTR polymorphism in ischemic stroke: analysis in 3 populations.
Stroke 2007 Apr;38(4):1189-96

The Siblings With Ischemic Stroke Study (SWISS): a progress report.
Clin Med Res 2006 Mar;4(1):12-21

Siblings With Ischemic Stroke Study (SWISS).
Ongoing Clinical Trials Session, 28th International Stroke Conference, 2003 [PDF Format]

The Siblings With Ischemic Stroke Study (SWISS) Protocol.

SWISS Publications Pending

SWISS
ClinicalTrials.gov

This information last updated on: 10/16/2009

Reviewed on: 05/14/2010.

UID: 236

   

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