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Mechanisms of Stroke in Intracranial Stenosis (MoSIS)

This study has been terminated.
(The affiliated study SAMMPRIS (Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis) has stopped enrollment.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01152944
First Posted: June 29, 2010
Last Update Posted: February 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Jose Romano, MD, University of Miami
  Purpose
The objective of this SAMMPRIS-affiliated study is to understand the mechanisms the mechanisms that underlie ischemic stroke recurrence in high-grade intracranial atherosclerotic disease in order to determine predictors of recurrent stroke. MoSIS will evaluate 6 specific mechanisms of stroke in the medically-treated SAMMPRIS cohort: decreased antegrade flow, progression of stenosis, decreased proximal collateral flow, decreased distal collateral flow, impaired cerebrovascular reserve, and artery-to-artery embolism.

Condition
Stroke

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mechanisms of Stroke in Intracranial Stenosis and Stenting

Further study details as provided by Jose Romano, MD, University of Miami:

Primary Outcome Measures:
  • Ischemic stroke in the territory of the stenotic artery [ Time Frame: 2 years from enrollment ]

Enrollment: 100
Study Start Date: July 2010
Study Completion Date: December 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Medical arm of the SAMMPRIS trial which includes recently symptomatic (<30 days) high grade (70% or more)intracranial stenosis of the carotid, middle cerebral, vertebral or basilar arteries.
Criteria

Inclusion Criteria:

  • Enrolled in the medical arm of SAMMPRIS, signed consent

Exclusion Criteria:

  • For QMRA testing: contraindications to MRI; for TCD testing, abscence of ultrasonographic windows.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01152944


Locations
United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
Jose Romano, MD
National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Responsible Party: Jose Romano, MD, Associate Professor of Neurology. Director of Cerebrovascular Division, University of Miami
ClinicalTrials.gov Identifier: NCT01152944     History of Changes
Other Study ID Numbers: 1R01NS069938-01 ( U.S. NIH Grant/Contract )
First Submitted: June 28, 2010
First Posted: June 29, 2010
Last Update Posted: February 7, 2012
Last Verified: February 2012

Keywords provided by Jose Romano, MD, University of Miami:
Symptomatic intracranial atherosclerotic disease enrolled in the medical arm of SAMMPRIS

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases