NCT02447094

Brief Summary

To study the effect of a telemedicine model of stroke care on patient-based outcomes.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 18, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Last Updated

February 9, 2016

Status Verified

February 1, 2016

Enrollment Period

2 years

First QC Date

May 9, 2015

Last Update Submit

February 8, 2016

Conditions

Stroke

Keywords

ischemictPAtele-medicinerobottele-stroke

Outcome Measures

Primary Outcomes (1)

  • HRQoL

    Health Related Quality of Life

    6 months

Secondary Outcomes (1)

  • mRS

    6 months

Study Arms (2)

Exposed

AIS patients evaluated through RTP and who receive i.v. tPA

Drug: Alteplase

Un-exposed

AIS patients evaluated through RTP and who do not receive i.v. tPA

Interventions

AlteplaseDRUG

Intravenous (i.v.) tPA per the standard of care

Also known as: Recombinant tissue plasminogen activator (tPA)
Exposed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This research will be performed only in AIS patients who are routinely admitted to our "Hub" and participating "spoke" centers.

You may qualify if:

  • Patients with suspected acute ischemic stroke (AIS)
  • Age \>17 years

You may not qualify if:

  • Hemorrhagic strokes (ICH or SAH)
  • Transient ischemic attacks (TIA)
  • Trauma
  • Inability to obtain informed consent
  • Participation in another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

StrokeIschemia

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBiological Factors

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Neurology and Neurosurgery

Study Record Dates

First Submitted

May 9, 2015

First Posted

May 18, 2015

Study Start

February 1, 2015

Primary Completion

February 1, 2017

Last Updated

February 9, 2016

Record last verified: 2016-02

Locations

US(1)