Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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.)
Information provided by (Responsible Party):
Jose Romano, MD, University of Miami Identifier:
First received: June 28, 2010
Last updated: February 6, 2012
Last verified: February 2012

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.


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 University of Miami:

Primary Outcome Measures:
  • Ischemic stroke in the territory of the stenotic artery [ Time Frame: 2 years from enrollment ] [ Designated as safety issue: No ]

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)

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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.


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.
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Please refer to this study by its identifier: NCT01152944

United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
Jose Romano, MD
  More Information

No publications provided

Responsible Party: Jose Romano, MD, Associate Professor of Neurology. Director of Cerebrovascular Division, University of Miami Identifier: NCT01152944     History of Changes
Other Study ID Numbers: 1R01NS069938-01, 1R01NS069938-01
Study First Received: June 28, 2010
Last Updated: February 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
Symptomatic intracranial atherosclerotic disease enrolled in the medical arm of SAMMPRIS processed this record on March 03, 2015