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:
Collaborator:
Information provided by (Responsible Party):
Jose Romano, MD, University of Miami
ClinicalTrials.gov Identifier:
NCT01152944
First received: June 28, 2010
Last updated: February 6, 2012
Last verified: February 2012
  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

Resource links provided by NLM:


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)
  Eligibility

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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01152944

Locations
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
ClinicalTrials.gov 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

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

ClinicalTrials.gov processed this record on August 19, 2014