Heart Attack and StrokeECHASNCT05230069
Emergency Call for Heart Attack and Stroke (ECHAS) - ECHAS One Study
An observational study of Heart Attack and Stroke, run by Emergency Call for Heart Attack and Stroke (ECHAS).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Attack and Stroke
- What is being tested?
- Interview
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: 200 patients who activated emergency system for symptoms of possible heart attack or stroke.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Attack and Stroke
- Being tested
- Interview
- Keywords
- Triage, Smartphone
- Medical subject headings
- Myocardial Infarction, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Patients will be interviewed post an emergency call and evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Patients post emergency evaluation | Interview of patients post notification of emergency system Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appropriate Emergency Activation
Was the right call made for a possible heart attack or stroke
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start1 Apr 2022 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Attack and StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emergency Call for Heart Attack and Stroke (ECHAS)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Saskatchewan
- Responsible party
- Sponsor
- Investigators
- James E Muller, Study director, CEO, ECHAS, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230069
- Sponsor's protocol ID
- ECHAS One
- Acronym
- ECHAS
- Status last verified
- Jan 2022
- First submitted
- 28 Jan 2022
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Prehospital Mobile App and Sensor Triage System to Detect Neurologic and Cardiac Emergencies: The ECHAS Assessment Study (ECHAS- One)
- ClinicalTrials.gov ID
- NCT05230069
- Acronym / sponsor ID
- ECHAS / ECHAS One
- Conditions
- Heart Attack and Stroke
- Keywords
- Triage, Smartphone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Emergency Call for Heart Attack and Stroke (ECHAS)Industry (pharma, biotech, devices)
- Collaborators
- University of Saskatchewan
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients post emergency evaluation | – | Other: InterviewInterview of patients post notification of emergency system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 200 patients who activated emergency system for symptoms of possible heart attack or stroke.
Key inclusion criteria (4 listed)
- Presented to ED via emergency medical services (EMS) for "Stroke alert" symptoms, including:
- Slurred speech Asymmetric weakness or numbness Balance problems Vision changes Headache
- Chest discomfort Chest pressure or pain Palpitations Shortness of breath Lightheadedness or presyncope Syncope Age ≥ 18 years Able to provide informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewPatients will be interviewed post an emergency call and evaluation. | Other | Patients post emergency evaluation |
Primary outcome
Appropriate Emergency Activation
Time frame: 3 months
Was the right call made for a possible heart attack or stroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James E Muller study director
CEO, ECHAS, LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Attack and Stroke, run by Emergency Call for Heart Attack and Stroke (ECHAS).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James E Muller (6177178570, james.muller19@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appropriate Emergency Activation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.