Mechanisms of Stroke in Intracranial Stenosis | NCT01152944

Studies
Mechanisms of Stroke in Intracranial Stenosis

NCT01152944

Sponsor

Jose Romano, MD

Status

Terminated

Last Update Posted

Feb 7, 2012Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Stroke

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R01NS069938-01	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The affiliated study SAMMPRIS (Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis) has stopped enrollment.

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Apr 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Jun 28, 2010

First Submission Date that Met QC Criteria

Jun 28, 2010

First Posted Date

Jun 29, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2012

Last Update Posted Date

Feb 7, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jose Romano, MD, Associate Professor of Neurology. Director of Cerebrovascular Division, University of MiamiSponsor-Investigator

Lead Sponsor

Jose Romano, MDOTHER

Collaborators

Name	Class
National Institute of Neurological Disorders and Stroke (NINDS)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ischemic stroke in the territory of the stenotic artery		2 years from enrollment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Miami		Miami	Florida	33136	United States

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided