NCT04057404

Brief Summary

The primary objective is to determine if the Smartphone electrocardiogram (ECG) is an acceptable replacement for a standard ECG in the identification of ST elevation myocardial infarction (STEMI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2019

Completed
Last Updated

August 19, 2019

Status Verified

August 1, 2019

Enrollment Period

2.9 years

First QC Date

August 13, 2019

Last Update Submit

August 15, 2019

Conditions

ST Elevated Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Determine the number of agreements in diagnoses (STEMI vs. non-STEMI) between the standard 12-lead ECG and the iPhone "12-lead equivalent" ECG

    Number of Agreements

    10 Weeks

Interventions

Alivecor Heart MonitorDEVICE
Also known as: Smartphone ECG

Eligibility Criteria

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

Male or female patients, \>18 years old, who are seen for chest pain, and/or patients for whom the STEMI protocol has been activated, will be screened for this study.

You may qualify if:

  • Male or female \>= 18 years of age.
  • Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures (patient or legally acceptable representative).
  • Symptoms of chest pain upon presentation at the INTEGRIS Baptist Medical Center Emergency Department

You may not qualify if:

  • Inability or refusal of the patient and/or the patient's legally-acceptable representative to provide written informed consent for any reason.
  • Other conditions that in the opinion of the Principal Investigator or Co-Investigator(s) may increase risk to the subject and/or compromise the quality of the clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INTEGRIS Baptist Medical Center

Oklahoma City, Oklahoma, 73162, United States

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 13, 2019

First Posted

August 15, 2019

Study Start

September 1, 2015

Primary Completion

July 30, 2018

Study Completion

July 30, 2018

Last Updated

August 19, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)