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CompletedNCT03080233Updated Jan 10, 2018

Validation of Clinical Decision Support Tool for Acute Stroke Diagnosis (InstaDx)

An observational study in Stroke, Acute, sponsored by Aga Khan University. Completed at 1 site in Pakistan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-10.

Sponsored by Aga Khan University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
210
Ages
18 Years and older
Sex
All
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Study summary

This is a observational validation study. The Stroke Clinical Decision Support Tool ( InstaDx) , an information technology application will be adapted and developed in accordance to evidence based clinical practice guidelines ( Level IA). Neurology Residents will be using the InstaDx CDST to improve their diagnostic accuracy and the findings will be validated against the review of a stroke subject expert. The study hypothesis is that Clinical Decision Support Tool used by neurology residents will have an agreement of >0.77 when compared to Stroke Expert (gold standard) in diagnosing type of ischemic stroke.

Read the detailed description

Overall Objective: To adapt, develop and validate the clinical decision support tool, an information technology application to assist acute stroke diagnosis for use among neurology graduate trainees compared to stroke expert (gold standard).

Specific Aims:

  1. To validate the adapted clinical decision support tool, an information technology application to assist acute ischemic stroke diagnosis for use among neurology residents compared to stroke expert (Gold standard) in the adult population presenting at a tertiary care hospital in Pakistan.

The study will be conducted in Emergency department and the Neurology ward at Aga Khan University Hospital. The data collector will enroll the patients meeting the eligibility criteria and providing informed consent. Neurology residents will use the Clinical Decision Support Tool application to assist in acute stroke diagnosis. In the second part, the Stroke Expert will independently assess all diagnosis. The purpose of this would be to validate the Clinical Decision Support Tool application to assist in acute stroke diagnosis.

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Conditions studied

  • Stroke, Acute

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Keywords

  • stroke
  • Validation
  • Clinical decision support tool
03

In context

Stroke

7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's enrollment of 210 is above the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Aga Khan University is the lead sponsor of 290 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All men and women greater than or equal to 18 years of age presenting in emergency department with neurological deficit consistent with stroke, fulfilling our eligibility criteria and willing to give voluntary informed consent to participate in the study.

Inclusion criteria

  1. Adult men and women, >18 years of age.
  2. Patients admitted with neurological deficit consistent with stroke.
  3. Confirmation of stroke by objective modality of CT scan and MRI.
  4. Consenting to participate in the study.

Exclusion criteria

Exclusion Criteria:

  1. Patients presenting with any type of Haemorrhagic stroke such as Sub-Arachnoid Haemorrhage, Intracerebral Haemorrhage and others.
  2. Stroke due to any iatrogenic causes such as post-surgeries, trauma, or any rare or non atherosclerotic causes eg carotid dissection.
  3. Patients signing LAMA (left against Medical Advice) and leaving undiagnosed
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
210 participants (actual)
Patient registry
No

Groups and cohorts

  • Pakistani adult

    Men and women aged 18 years or above,presenting with neurological deficit consistent with stroke in the Emergency Department at Aga Khan University Hospital Consenting to participate in the study

06

What researchers measure

Primary outcomes

  1. Validation_Primary Outcome Measure_ Sensitivity

    Sensitivity of InstaDx used by Neurology Residents vs. Diagnosis by Stroke Expert

    Time frame: Day 1

  2. Validation_ Primary Outcome Measure_Specificity

    Specificity of InstaDx used by Neurology Residents vs. Diagnosis by Stroke Expert

    Time frame: Day 1

  3. Validation_Primary Outcome Measure_Positive and Negative Predictive Values

    Predictive Value of InstaDx used by Neurology Residents vs. Diagnosis by Stroke Expert

    Time frame: Day 1

Secondary outcomes

  1. Acceptability

    Qualitative assessments by focus group discussion will be performed to incorporate user feedback

    Time frame: Day 1

Other outcomes

  1. Implementation Characteristics

    Qualitative assessments by focus group discussion will be performed to evaluate the user feedback to further improve the uptake of the tool.

    Time frame: Day 1

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Study locations

1 site
  • Aga Khan University
    Karachi, 74800, Pakistan
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References and documents

Individual participant data

Plan to share: No — This may be shared on request only.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03080233
Lead sponsor
Aga Khan University
Responsible party
Dr. Ayeesha Kamran Kamal (Associate Professor, Aga Khan University) — Principal investigator
First posted
Mar 15, 2017
Start date
Feb 1, 2017
Primary completion
Jun 30, 2017
Completion
Jun 30, 2017
Last update
Jan 10, 2018

Study contacts

Ayeesha K Kamal
principal investigator · AKUH
Saadia S Choudhry
principal investigator · AKUH

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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