Emergency Call for Heart Attack and Stroke (ECHAS) - ECHA... | NCT05230069

Studies
Emergency Call for Heart Attack and Stroke (ECHAS) - ECHAS One Study

NCT05230069

Sponsor

Emergency Call for Heart Attack and Stroke (ECHAS)

Status

Unknown status

Last Update Posted

Feb 8, 2022Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Heart Attack and Stroke

Interventions

Interview

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2022Estimated

Primary Completion Date

Oct 1, 2022Estimated

Completion Date

Dec 1, 2022Estimated

First Submitted Date

Jan 28, 2022

First Submission Date that Met QC Criteria

Jan 28, 2022

First Posted Date

Feb 8, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2022

Last Update Posted Date

Feb 8, 2022Actual

Name	Class
University of Saskatchewan	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients post emergency evaluation		Interview of patients post notification of emergency system	Other: Interview

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Interview	Other	Patients will be interviewed post an emergency call and evaluation.	Patients post emergency evaluation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Appropriate Emergency Activation	Was the right call made for a possible heart attack or stroke	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
James E Muller	Contact	6177178570		james.muller19@gmail.com

Name	Affiliation	Role
James E Muller	CEO, ECHAS, LLC	Study Director

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009203	Myocardial Infarction
D020521	Stroke

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007407	Interviews as Topic

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided