- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05230069
Emergency Call for Heart Attack and Stroke (ECHAS) - ECHAS One Study (ECHAS)
January 28, 2022 updated by: Emergency Call for Heart Attack and Stroke (ECHAS)
Assessment of a Prehospital Mobile App and Sensor Triage System to Detect Neurologic and Cardiac Emergencies: The ECHAS Assessment Study (ECHAS- One)
ECHAS One will test the use of a smartphone app to assist patients to decide if it is necessary to call for emergency care with symptoms that could represent a heart attack or stroke.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
The ECHAS One Study will be conducted in 200 patients who have already called for emergency care for a heart or stroke, and have been evaluated.
The endpoint of the study will be a decision if the initial call was an appropriate call for emergency care.
The sensitivity of the app for detecting appropriate calls will be assessed.
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: James E Muller
- Phone Number: 6177178570
- Email: james.muller19@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
200 patients who activated emergency system for symptoms of possible heart attack or stroke.
Description
Inclusion Criteria:
- Presented to ED via emergency medical services (EMS) for "Stroke alert" symptoms, including:
Slurred speech Asymmetric weakness or numbness Balance problems Vision changes Headache
And/or "MI alert" symptoms including:
Chest discomfort Chest pressure or pain Palpitations Shortness of breath Lightheadedness or presyncope Syncope Age ≥ 18 years Able to provide informed consent
Exclusion Criteria:
- Non-English speaking
- Moderate or greater dementia
- Severe visual impairment
- Inability to use smartphone (for physical, cognitive, or other reasons)
- Unable to consent for study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients post emergency evaluation
Interview of patients post notification of emergency system
|
Patients will be interviewed post an emergency call and evaluation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Appropriate Emergency Activation
Time Frame: 3 months
|
Was the right call made for a possible heart attack or stroke
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: James E Muller, CEO, ECHAS, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 1, 2022
Primary Completion (Anticipated)
October 1, 2022
Study Completion (Anticipated)
December 1, 2022
Study Registration Dates
First Submitted
January 28, 2022
First Submitted That Met QC Criteria
January 28, 2022
First Posted (Actual)
February 8, 2022
Study Record Updates
Last Update Posted (Actual)
February 8, 2022
Last Update Submitted That Met QC Criteria
January 28, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ECHAS One
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.