Myocardial InfarctionNCT05290389
A Smartphone APPlication for the Transmission of ECGs in the Management of Patients Presenting With Suspected Heart Attacks in the Hamilton, Niagara, Haldimand, and Brant Area
An observational study of Myocardial Infarction and STEMI, run by McMaster University at 17 sites in Canada.
Trial summary
The delivery of timely and appropriate care is crucial for patients with heart attacks. Blocked arteries need immediate intervention to restore blood flow. However, the intervention to open the artery is only available in large, regional hospitals. There are only 18 such hospitals across Ontario. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, STEMI
- What is being tested?
- SMART AMI APPLICATION
- How many people
- 260 participants
- Where
- 17 sitesCanada
- Study dates
- 4 Apr 2022to 30 Nov 2023
- How long will I take part?
- 12 Months
- 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: Physicians: Emergency Medicine physicians working at the partner emergency departments and urgent care centres that refer STEMI patients to the cardiac catheterization lab at Hamilton General Hospital.
Who may be able to join
- Emergency Medicine physicians at hospitals and urgent care centres located in the Hamilton, Niagara and Brant Local Health area:
- Brantford General Hospital
- Fort Erie Urgent Care Center
- Greater Niagara General Hospital
- Haldimand War Memorial Hospital
- Hamilton General Hospital
Show all 18Show fewer
- Joseph Brant Hospital
- Juravinski Hospital
- Main Street West UCC
- Norfolk General Hospital
- Port Colborne Urgent Care Center
- St. Catharines General Hospital
- St. Joseph's Hospital
- St. Joseph's Urgent Care Center
- Welland County General Hospital
- West Haldimand General Hospital
- West Lincoln Memorial Hospital
- Willett Urgent Care Centre
Who cannot join
- N/A
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Canada17 sites
Brantford General Hospital
Brantford, Ontario, N3R 1G9
Joseph Brant Hospital
Burlington, Ontario, L7S 0A2
Haldimand War Memorial Hospital
Dunnville, Ontario, N1A 2P7
Fort Erie Urgent Care Center
Fort Erie, Ontario, L2A 1Z2
West Lincoln Memorial Hospital
Grimsby, Ontario, L3M 1P3
West Haldimand General Hospital
Hagersville, Ontario, N0A 1H0
St. Joseph's Urgent Care Center
Hamilton, Ontario, L8G 5E4
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
St. Joseph's Hospital
Hamilton, Ontario, L8N 4A6
Main Street West UCC
Hamilton, Ontario, L8S 1A4
Juravinski Hospital
Hamilton, Ontario, L8V 1C3
Greater Niagara General Hospital
Niagara Falls, Ontario, L2E 6X2
Willett Urgent Care Centre
Paris, Ontario, N3L 2M7
Port Colborne Urgent Care Center
Port Colborne, Ontario, L3K 2N7
Norfolk General Hospital
Simcoe, Ontario, N3Y 1T7
St. Catharines General Hospital
St. Catharines, Ontario, L2S 0A9
Welland County General Hospital
Welland, Ontario, L3B 4W6
About this study
Official title: Enhancing Strategic Management of Acute Reperfusion and Therapies in Acute Myocardial Infarction Using a Novel Smartphone APPlication (SMART-AMI APP)
The delivery of timely and appropriate care is crucial for patients with heart attacks. Blocked arteries need immediate intervention to restore blood flow. However, the intervention to open the artery is only available in large, regional hospitals. There are only 18 such hospitals across Ontario. Patients with heart attacks in smaller hospitals, where the majority of patients present, require transfer for specialized services. The smartphone application being evaluated in this study is meant to help with communication between doctors to arrange transfer of such patients.
The current model for communication is based on fax machines or non-secure text messages. Additionally, these are not easily accessible for most physicians, so decisions to transfer patients may be based on incomplete information. Unnecessary transfer, treatments, and procedures expose patients and healthcare providers to undue risk.
Smartphone technology is well integrated into clinical practice and widely accessible. The proposed solution being tested is secure and leverages the accessibility of smartphones. Emergency physicians can use this to quickly, securely, and accurately transmit information ensuring faster and appropriate decision making for transfers.
Read the detailed description
A multi-centre, mixed methods observational study focused on Emergency Department physicians who care for patients presenting to a regional partner hospital in the Hamilton, Niagara, Haldimand, Brant Local Health Integration Network (Canada) with suspected ST-segment Elevation Myocardial Infarction (STEMI). There are approximately 700 STEMI patients per year transferred and treated in the Hamilton General Hospital Cardiac Catheterization Lab. As this study is expected to run over the course of one year, it is anticipated that aggregate patient level data on approximately 700 STEMI patients in the STEMI database will be reviewed.
The study will use a pre-post design to evaluate the implementation and use of a clinical intervention, the SMART AMI App. The study will use quantitative registry data already being collected via the ongoing SMART-AMI project (e.g., STEMI database), utilization of data collected from the SMART AMI App, and quantitative and qualitative survey data from participating physicians. As the intervention in this study is a change in process to improve communication between Emergency Department physicians and Interventional Cardiologists, the study does not directly involve patients and individual patient consent will not be required. No new patient data will be collected for the purposes of this study.
Descriptive quantitative analysis and thematic qualitative analysis of survey results will be conducted. Descriptive and inferential statistics will be used for quantitative data derived from patient charts/registry and physician surveys. Continuous variables will be described using mean ± standard deviation. An interrupted time series analysis will be used to compare trends on time-based quality of care indicators. Categorical variables, such as false activation, will be described as frequencies and compared using a Fisher exact test or chi-square test.
Funding for this study was provided by the Hamilton Academic Health Sciences Organization (HAHSO) #HAH-21-015.
- Conditions
- Myocardial Infarction, STEMI
- Being tested
- SMART AMI APPLICATION
- Keywords
- Mixed-methods, Promote Efficient Delivery of Health Care Resources, Technology, Health Care Delivery
- Medical subject headings
- Myocardial Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMART AMI APPLICATIONOther
SMART AMI allows real-time sharing and review of patient history and ECG between Emergency Department physicians and Interventional Cardiologists to allow for immediate decision-making regarding the need for percutaneous coronary intervention.
Participant physicians will use a smartphone application to communicate, transmit the ECG, and activate the STEMI team. This application enables calling and transmission of up to three images of ECGs, which can be reviewed immediately by the Interventional Cardiologist when communicating with the referring physician.
| Study group | Role | What they receive |
|---|---|---|
| Physicians | All Emergency Medicine physicians and Interventional Cardiologists involved in STEMI care in the Hamilton Niagara Haldimand Brant Local Health area will be eligible for participation in this study. Receives: Other: SMART AMI APPLICATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability
The first primary outcome is usability of the App for Emergency Medicine physicians. This will be measured using electronic surveys and focus groups to identify barriers and facilitators faced when using the App.
Measured: 12 months
Acceptability
The second primary outcome is acceptability of the App for Emergency Medicine physicians. This will be measured using the mHealth App Usability Questionnaire.
Measured: 12 months
Functionality
The third primary outcome will measure functionality of the App for Emergency Medicine physicians. Through electronic surveys, barriers and facilitators faced when using the App will be assessed.
Measured: 12 months
Secondary outcomes (4)
Implementation
The secondary outcome will measure implementation of the App. This will be acquired by the number of Emergency Medicine physicians who signed up for the App and used the App. This measurement will be acquired from Google Data Analytics.
Measured: 12 months
Timing of Care Intervals
Further secondary outcomes include measuring effectiveness of the App through timing of care intervals. This outcome will be acquired from a consecutive sample of patients from the regional STEMI registry. As these data are already collected as part of the ongoing SMART AMI program, no new patient data will need to be collected for the purpose of this study.
Measured: 12 months
False Positive Activation Rates
Effectiveness of the App will be further measured by false positive STEMI activation rates. This outcome will be acquired from a consecutive sample of patients from the regional STEMI registry. As these data are already collected as part of the ongoing SMART AMI program, no new patient data will need to be collected for the purpose of this study.
Measured: 12 months
STEMI Activations via App
Effectiveness will also be measured by the rate of STEMI activations that utilized the App. This outcome will be acquired from a consecutive sample of patients from the regional STEMI registry. As these data are already collected as part of the ongoing SMART AMI program, no new patient data will need to be collected for the purpose of this study.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start4 Apr 2022
- Primary completion31 Mar 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- 260 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, Centre for Evidence-Based Implementation
- Responsible party
- Sponsor
- Investigators
- Madhu K Natarajan, MD, Principal investigator, Hamilton Health Sciences CorporationMathew Mercuri, PhD, Principal investigator, Hamilton Health Sciences CorporationHassan K Mir, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290389
- Sponsor's protocol ID
- HAH-21-015
- Status last verified
- Nov 2023
- First submitted
- 22 Feb 2022
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cullen KJ, Mir H, Natarajan MK, Corovic M, Mosleh K, Crawshaw J, Mercuri M, Masoom H, Schwalm JD. Exploring the Barriers and Facilitators to Implementing a Smartphone App for Physicians to Improve the Management of Acute Myocardial Infarctions: Multicenter, Mixed Methods, Observational Study. JMIR Mhealth Uhealth. 2025 Jul 8;13:e60173. doi: 10.2196/60173.
PubMed 40627818Mir H, Cullen KJ, Mosleh K, Setrak R, Jolly S, Tsang M, Rutledge G, Ibrahim Q, Welsford M, Mercuri M, Schwalm JD, Natarajan MK. Smartphone App for Prehospital ECG Transmission in ST-Elevation Myocardial Infarction Activation: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2024 Sep 6;13:e55506. doi: 10.2196/55506.
PubMed 39240681
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Strategic Management of Acute Reperfusion and Therapies in Acute Myocardial Infarction Using a Novel Smartphone APPlication (SMART-AMI APP)
- ClinicalTrials.gov ID
- NCT05290389
- Acronym / sponsor ID
- HAH-21-015
- Conditions
- Myocardial Infarction, STEMI
- Keywords
- Mixed-methods, Promote Efficient Delivery of Health Care Resources, Technology, Health Care Delivery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, Centre for Evidence-Based Implementation
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 22 Mar 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.
The delivery of timely and appropriate care is crucial for patients with heart attacks. Blocked arteries need immediate intervention to restore blood flow. However, the intervention to open the artery is only available in large, regional hospitals. There are only 18 such hospitals across Ontario. Patients with heart attacks in smaller hospitals, where the majority of patients present, require transfer for specialized services. The smartphone application being evaluated in this study is meant to help with communication between doctors to arrange transfer of such patients.
The current model for communication is based on fax machines or non-secure text messages. Additionally, these are not easily accessible for most physicians, so decisions to transfer patients may be based on incomplete information. Unnecessary transfer, treatments, and procedures expose patients and healthcare providers to undue risk.
Smartphone technology is well integrated into clinical practice and widely accessible. The proposed solution being tested is secure and leverages the accessibility of smartphones. Emergency physicians can use this to quickly, securely, and accurately transmit information ensuring faster and appropriate decision making for transfers.
Detailed description
A multi-centre, mixed methods observational study focused on Emergency Department physicians who care for patients presenting to a regional partner hospital in the Hamilton, Niagara, Haldimand, Brant Local Health Integration Network (Canada) with suspected ST-segment Elevation Myocardial Infarction (STEMI). There are approximately 700 STEMI patients per year transferred and treated in the Hamilton General Hospital Cardiac Catheterization Lab. As this study is expected to run over the course of one year, it is anticipated that aggregate patient level data on approximately 700 STEMI patients in the STEMI database will be reviewed.
The study will use a pre-post design to evaluate the implementation and use of a clinical intervention, the SMART AMI App. The study will use quantitative registry data already being collected via the ongoing SMART-AMI project (e.g., STEMI database), utilization of data collected from the SMART AMI App, and quantitative and qualitative survey data from participating physicians. As the intervention in this study is a change in process to improve communication between Emergency Department physicians and Interventional Cardiologists, the study does not directly involve patients and individual patient consent will not be required. No new patient data will be collected for the purposes of this study.
Descriptive quantitative analysis and thematic qualitative analysis of survey results will be conducted. Descriptive and inferential statistics will be used for quantitative data derived from patient charts/registry and physician surveys. Continuous variables will be described using mean ± standard deviation. An interrupted time series analysis will be used to compare trends on time-based quality of care indicators. Categorical variables, such as false activation, will be described as frequencies and compared using a Fisher exact test or chi-square test.
Funding for this study was provided by the Hamilton Academic Health Sciences Organization (HAHSO) #HAH-21-015.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physicians | – | Other: SMART AMI APPLICATIONAll Emergency Medicine physicians and Interventional Cardiologists involved in STEMI care in the Hamilton Niagara Haldimand Brant Local Health area will be eligible for participation in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Physicians: Emergency Medicine physicians working at the partner emergency departments and urgent care centres that refer STEMI patients to the cardiac catheterization lab at Hamilton General Hospital.
Key inclusion criteria (18 listed)
- Emergency Medicine physicians at hospitals and urgent care centres located in the Hamilton, Niagara and Brant Local Health area:
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| SMART AMI APPLICATIONSMART AMI allows real-time sharing and review of patient history and ECG between Emergency Department physicians and Interventional Cardiologists to allow for immediate decision-making regarding the need for percutaneous coronary intervention. Participant physicians will use a smartphone application to communicate, transmit the ECG, and activate the STEMI team. This application enables calling and transmission of up to three images of ECGs, which can be reviewed immediately by the Interventional Cardiologist when communicating with the referring physician. | Other | Physicians |
Primary outcome
Usability
Time frame: 12 months
The first primary outcome is usability of the App for Emergency Medicine physicians. This will be measured using electronic surveys and focus groups to identify barriers and facilitators faced when using the App.
Acceptability
Time frame: 12 months
The second primary outcome is acceptability of the App for Emergency Medicine physicians. This will be measured using the mHealth App Usability Questionnaire.
Functionality
Time frame: 12 months
The third primary outcome will measure functionality of the App for Emergency Medicine physicians. Through electronic surveys, barriers and facilitators faced when using the App will be assessed.
4 secondary outcomes
Implementation
Time frame: 12 months
Timing of Care Intervals
Time frame: 12 months
False Positive Activation Rates
Time frame: 12 months
STEMI Activations via App
Time frame: 12 months
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 30 Nov 2023.
- Derived from this study: PubMed 40627818Cullen KJ, Mir H, Natarajan MK, Corovic M, Mosleh K, Crawshaw J, Mercuri M, Masoom H, Schwalm JD. Exploring the Barriers and Facilitators to Implementing a Smartphone App for Physicians to Improve the Management of Acute Myocardial Infarctions: Multicenter, Mixed Methods, Observational Study. JMIR Mhealth Uhealth. 2025 Jul 8;13:e60173. doi: 10.2196/60173.
- Derived from this study: PubMed 39240681Mir H, Cullen KJ, Mosleh K, Setrak R, Jolly S, Tsang M, Rutledge G, Ibrahim Q, Welsford M, Mercuri M, Schwalm JD, Natarajan MK. Smartphone App for Prehospital ECG Transmission in ST-Elevation Myocardial Infarction Activation: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2024 Sep 6;13:e55506. doi: 10.2196/55506.
- 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.
Madhu K Natarajan, MD principal investigator
Hamilton Health Sciences Corporation
Mathew Mercuri, PhD principal investigator
Hamilton Health Sciences Corporation
Hassan K Mir, MD principal investigator
Ottawa Heart Institute Research Corporation
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and STEMI, run by McMaster University at 17 sites in Canada.
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 18 inclusion and 1 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 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Canada. 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?
Usability (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05290389, which also lists 2 linked publications.
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 30 Nov 2023.