NCT05230069

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

January 28, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 8, 2022

Status Verified

January 1, 2022

Enrollment Period

6 months

First QC Date

January 28, 2022

Last Update Submit

January 28, 2022

Conditions

Keywords

TriageSmartphone

Outcome Measures

Primary Outcomes (1)

  • Appropriate Emergency Activation

    Was the right call made for a possible heart attack or stroke

    3 months

Study Arms (1)

Patients post emergency evaluation

Interview of patients post notification of emergency system

Other: Interview

Interventions

Patients will be interviewed post an emergency call and evaluation.

Patients post emergency evaluation

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

200 patients who activated emergency system for symptoms of possible heart attack or stroke.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myocardial InfarctionStroke

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • James E Muller

    CEO, ECHAS, LLC

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2022

First Posted

February 8, 2022

Study Start

April 1, 2022

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

February 8, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share