NCT01152944

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2010

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 7, 2012

Status Verified

February 1, 2012

Enrollment Period

9 months

First QC Date

June 28, 2010

Last Update Submit

February 6, 2012

Conditions

Keywords

Symptomatic intracranial atherosclerotic disease enrolled in the medical arm of SAMMPRIS

Outcome Measures

Primary Outcomes (1)

  • Ischemic stroke in the territory of the stenotic artery

    2 years from enrollment

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Enrolled in the medical arm of SAMMPRIS, signed consent

You may not qualify if:

  • For QMRA testing: contraindications to MRI; for TCD testing, abscence of ultrasonographic windows.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Neurology. Director of Cerebrovascular Division

Study Record Dates

First Submitted

June 28, 2010

First Posted

June 29, 2010

Study Start

July 1, 2010

Primary Completion

April 1, 2011

Study Completion

December 1, 2011

Last Updated

February 7, 2012

Record last verified: 2012-02

Locations