STEMIST LEUISNCT03037229
Smartphone Twelve Lead Electrocardiogram Utility In ST-Elevation Myocardial Infarction
An observational study of STEMI, run by Mayo Clinic at 1 site in United States.
Trial summary
Is the Smartphone ECG (electrocardiogram) an acceptable replacement for a standard ECG in the identification of STEMI (ST Elevation Myocardial Infarction). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI
- What is being tested?
- Smartphone ECG and Standard 12-lead ECG
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Dec 2016to 6 Dec 2018
- 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
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Is the Smartphone ECG (electrocardiogram) an acceptable replacement for a standard ECG in the identification of STEMI (ST Elevation Myocardial Infarction).
Read the detailed description
The primary objective of this study 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).
Toward this objective, this study involves the following:
Obtain simultaneous recordings of a standard 12-lead ECG and the iPhone "12-lead equivalent" ECG on patients presenting with chest pain in which the STEMI protocol was activated.
Obtain simultaneous recordings of a standard 12-lead ECG and the iPhone "12-lead equivalent" ECG on patients presenting to the Emergency Department for evaluation of chest pain, not necessarily presenting with STEMI.
Reading of ECGs (standard 12-lead and iPhone) by three independent cardiologists, who are blinded to the initial clinical ECG readings, the type of ECG equipment used, and the patient's clinical information.
Assess the operational feasibility of using the Smartphone to obtain "12-lead equivalent" ECG recordings in patients suspected to have STEMI, and
Determine the possibility of pooling the data obtained from this study with data from other institutions conducting identical studies, and developing a future and statistical analysis plan to compare the sensitivity, specificity, positive predictive value and the negative predictive power of the iPhone ECG, using a paired standard 12-lead ECG as the gold standard.
There will be no therapeutic interventions. A single research-related procedure will be required, i.e., an iPhone ECG. Effort will be made to ensure that the performance of this procedure will not delay any treatment and/or diagnostic procedures that are part of usual or specialized care that the patient requires.
The individual patient's participation in the study will actually be only one day, i.e., the day the informed consent is obtained and the two comparison ECGs will be done.
- Conditions
- STEMI
- Being tested
- Smartphone ECG, Standard 12-lead ECG
- Keywords
- Myocardial Infarction, Ischemia, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases, Vascular Diseases
- Medical subject headings
- ST Elevation Myocardial Infarction, Myocardial Infarction, Ischemia, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone ECGDevice
Also called AliveCor Kardia Heart Monitor
Standard 12-lead ECGDevice
| Study group | Role | What they receive |
|---|---|---|
| STEMI | Subjects in which a STEMI protocol has been initiated.
* An attempt will be made to do the standard 12-lead ECG first, followed immediately after by the Smartphone ECG
* If the initial standard 12-lead ECG was already obtained, such as when the patient was first diagnosed with STEMI, a repeat ECG will be performed at the same time as the Smartphone ECG
* If possible, the two ECGs will be taken in the Emergency Department, the critical care unit (CCU), or the catheterization laboratory just prior to cardiac catheterization. If not, then the two ECG's will be taken just after the cardiac catheterization is completed (i.e., within one hour of the procedure) while the patient is still in the catheterization laboratory and waiting for transport to the CCU
* Both ECGs will be sent to the designated ECG reading station, to be read and evaluated by three independent cardiologists Receives: Device: Smartphone ECG; Device: Standard 12-lead ECG | |
| Chest Pain | Subjects presenting at the emergency department with chest pain.
* An attempt will be made to do the standard 12-lead ECG first, followed immediately after by the Smartphone ECG
* If the initial standard 12-lead ECG was already obtained, such as when the patient was first diagnosed with STEMI, a repeat ECG will be performed at the same time as the Smartphone ECG
* If possible, the two ECGs will be taken in the Emergency Department, the critical care unit (CCU), or the catheterization laboratory just prior to cardiac catheterization. If not, then the two ECG's will be taken just after the cardiac catheterization is completed (i.e., within one hour of the procedure) while the patient is still in the catheterization laboratory and waiting for transport to the CCU
* Both ECGs will be sent to the designated ECG reading station, to be read and evaluated by three independent cardiologists Receives: Device: Smartphone ECG; Device: Standard 12-lead ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients for whom the diagnoses (STEMI vs. non-STEMI) was in agreement between the standard 12-lead ECG and the iPhone "12-lead equivalent" ECG.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start29 Dec 2016
- Primary completion30 Jan 2018
- Study completion6 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMIStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- AliveCor
- Responsible party
- Principal investigator, Gregory W. Barsness, Mayo Clinic
- Investigators
- Gregory W Barsness, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037229
- Sponsor's protocol ID
- 16-004793
- Acronym
- ST LEUIS
- Status last verified
- Dec 2018
- First submitted
- 26 Jan 2017
- Last updated
- 7 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Twelve Lead Electrocardiogram Utility In ST-Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT03037229
- Acronym / sponsor ID
- ST LEUIS / 16-004793
- Conditions
- STEMI
- Keywords
- Myocardial Infarction, Ischemia, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases, Vascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- AliveCor
- Study start
- 29 Dec 2016 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 6 Dec 2018 (actual)
- First posted
- 31 Jan 2017 (estimated)
- 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.
Is the Smartphone ECG (electrocardiogram) an acceptable replacement for a standard ECG in the identification of STEMI (ST Elevation Myocardial Infarction).
Detailed description
The primary objective of this study 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).
Toward this objective, this study involves the following:
Obtain simultaneous recordings of a standard 12-lead ECG and the iPhone "12-lead equivalent" ECG on patients presenting with chest pain in which the STEMI protocol was activated.
Obtain simultaneous recordings of a standard 12-lead ECG and the iPhone "12-lead equivalent" ECG on patients presenting to the Emergency Department for evaluation of chest pain, not necessarily presenting with STEMI.
Reading of ECGs (standard 12-lead and iPhone) by three independent cardiologists, who are blinded to the initial clinical ECG readings, the type of ECG equipment used, and the patient's clinical information.
Assess the operational feasibility of using the Smartphone to obtain "12-lead equivalent" ECG recordings in patients suspected to have STEMI, and
Determine the possibility of pooling the data obtained from this study with data from other institutions conducting identical studies, and developing a future and statistical analysis plan to compare the sensitivity, specificity, positive predictive value and the negative predictive power of the iPhone ECG, using a paired standard 12-lead ECG as the gold standard.
There will be no therapeutic interventions. A single research-related procedure will be required, i.e., an iPhone ECG. Effort will be made to ensure that the performance of this procedure will not delay any treatment and/or diagnostic procedures that are part of usual or specialized care that the patient requires.
The individual patient's participation in the study will actually be only one day, i.e., the day the informed consent is obtained and the two comparison ECGs will be done.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEMI | – | Device: Smartphone ECG, Device: Standard 12-lead ECGSubjects in which a STEMI protocol has been initiated. * An attempt will be made to do the standard 12-lead ECG first, followed immediately after by the Smartphone ECG * If the initial standard 12-lead ECG was already obtained, such as when the patient was first diagnosed with STEMI, a repeat ECG will be performed at the same time as the Smartphone ECG * If possible, the two ECGs will be taken in the Emergency Department, the critical care unit (CCU), or the catheterization laboratory just prior to cardiac catheterization. If not, then the two ECG's will be taken just after the cardiac catheterization is completed (i.e., within one hour of the procedure) while the patient is still in the catheterization laboratory and waiting for transport to the CCU * Both ECGs will be sent to the designated ECG reading station, to be read and evaluated by three independent cardiologists |
| Chest Pain | – | Device: Smartphone ECG, Device: Standard 12-lead ECGSubjects presenting at the emergency department with chest pain. * An attempt will be made to do the standard 12-lead ECG first, followed immediately after by the Smartphone ECG * If the initial standard 12-lead ECG was already obtained, such as when the patient was first diagnosed with STEMI, a repeat ECG will be performed at the same time as the Smartphone ECG * If possible, the two ECGs will be taken in the Emergency Department, the critical care unit (CCU), or the catheterization laboratory just prior to cardiac catheterization. If not, then the two ECG's will be taken just after the cardiac catheterization is completed (i.e., within one hour of the procedure) while the patient is still in the catheterization laboratory and waiting for transport to the CCU * Both ECGs will be sent to the designated ECG reading station, to be read and evaluated by three independent cardiologists |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Smartphone ECGAlso: AliveCor Kardia Heart Monitor | Device | Chest Pain, STEMI |
| Standard 12-lead ECG | Device | Chest Pain, STEMI |
Primary outcome
Number of patients for whom the diagnoses (STEMI vs. non-STEMI) was in agreement between the standard 12-lead ECG and the iPhone "12-lead equivalent" ECG.
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
- 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.
Gregory W Barsness, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of STEMI, run by Mayo Clinic at 1 site in United States.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 7 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients for whom the diagnoses (STEMI vs. non-STEMI) was in agreement between the standard 12-lead ECG and the iPhone "12-lead equivalent" ECG. (time frame: Day 1). 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 7 Dec 2018.