NCT01657279

Brief Summary

Background: Several risk score models are now available to assist clinicians estimate outcomes after an acute ischemic stroke. Limited information is available on the predictive value of these scores compared to real outcomes and clinical judgment. Objectives: To compare clinician judgment with the use of a validated stroke risk score (iScore) and patients' outcomes.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jul 2012

Shorter than P25 for not_applicable stroke

Geographic Reach
2 countries

4 active sites

Status
completed

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

Study Start

First participant enrolled

July 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2012

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2012

Completed
Last Updated

October 30, 2012

Status Verified

October 1, 2012

Enrollment Period

1 month

First QC Date

July 30, 2012

Last Update Submit

October 27, 2012

Conditions

StrokeIschemic StrokeCerebrovascular Disease

Keywords

strokerisk scoreiScoreoutcomesmortalitydisabilityinstitutionalization

Outcome Measures

Primary Outcomes (1)

  • 30 Day Mortality or Disability (mRS >3) at discharge

    Death after 30 days from ischemic stroke onset or Disability following hospital discharge

Secondary Outcomes (2)

  • Death at 30 days

    30 days

  • Death or institutionalization at discharge

    up to 30 days after discharge

Study Arms (1)

Randomized clinical scenarios

EXPERIMENTAL

Clinicians are randomized to a sequence of 5 clinical scenarios

Other: Clinical scenarios

Interventions

Clinical scenariosOTHER

Clinicians will be randomized to a sequence of 5 clinical scenarios with a variable range of expected outcome \[i.e. from low (\<10%) to high (\>50%) expected risk death at 30 days\].

Randomized clinical scenarios

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Practicing and active physicians managing patients with stroke

You may not qualify if:

  • retired physicians
  • physicians not exposed to care for stroke patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

McGill University Health Centre

Montreal, Quebec, H3H 2R9, Canada

Location

Related Publications (3)

  • Saposnik G, Fang J, Kapral MK, Tu JV, Mamdani M, Austin P, Johnston SC; Investigators of the Registry of the Canadian Stroke Network (RCSN); Stroke Outcomes Research Canada (SORCan) Working Group. The iScore predicts effectiveness of thrombolytic therapy for acute ischemic stroke. Stroke. 2012 May;43(5):1315-22. doi: 10.1161/STROKEAHA.111.646265. Epub 2012 Feb 3.

    PMID: 22308252BACKGROUND

  • Saposnik G, Raptis S, Kapral MK, Liu Y, Tu JV, Mamdani M, Austin PC; Investigators of the Registry of the Canadian Stroke Network and the Stroke Outcome Research Canada Working Group. The iScore predicts poor functional outcomes early after hospitalization for an acute ischemic stroke. Stroke. 2011 Dec;42(12):3421-8. doi: 10.1161/STROKEAHA.111.623116. Epub 2011 Sep 29.

    PMID: 21960583BACKGROUND

  • Saposnik G, Kapral MK, Liu Y, Hall R, O'Donnell M, Raptis S, Tu JV, Mamdani M, Austin PC; Investigators of the Registry of the Canadian Stroke Network; Stroke Outcomes Research Canada (SORCan) Working Group. IScore: a risk score to predict death early after hospitalization for an acute ischemic stroke. Circulation. 2011 Feb 22;123(7):739-49. doi: 10.1161/CIRCULATIONAHA.110.983353. Epub 2011 Feb 7.

    PMID: 21300951BACKGROUND

Related Links

MeSH Terms

Conditions

StrokeIschemic StrokeCerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Gustavo Saposnik, MD MSc FRCPC

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician and Clinician Scientist, Associate Professor of medicine, University of Toronto

Study Record Dates

First Submitted

July 30, 2012

First Posted

August 6, 2012

Study Start

July 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

October 30, 2012

Record last verified: 2012-10

Locations

CA(3)US(1)