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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03080233
Date of registration: 03/03/2017
Prospective Registration: No
Primary sponsor: Aga Khan University
Public title: Validation of Clinical Decision Support Tool for Acute Stroke Diagnosis (InstaDx)
Scientific title: Validation of Clinical Decision Support Tool Information Technology Application for Stroke Diagnosis
Date of first enrolment: February 1, 2017
Target sample size: 210
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03080233
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Pakistan
Contacts
Name:     Saadia S Choudhry
Address: 
Telephone:
Email:
Affiliation:  AKUH
Name:     Ayeesha K Kamal
Address: 
Telephone:
Email:
Affiliation:  AKUH
Key inclusion & exclusion criteria

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:

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Stroke, Acute
Intervention(s)
Primary Outcome(s)
Validation_Primary Outcome Measure_Positive and Negative Predictive Values [Time Frame: Day 1]
Validation_ Primary Outcome Measure_Specificity [Time Frame: Day 1]
Validation_Primary Outcome Measure_ Sensitivity [Time Frame: Day 1]
Secondary Outcome(s)
Acceptability [Time Frame: Day 1]
Secondary ID(s)
4554-CHS-ERC-16
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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