Atrial Fibrillation New OnsetSIMPL-AFNCT03345615
Standard Versus Intensive Monitoring After Myocardial Infarction Looking for Atrial Fibrillation
A study testing 30-day ambulatory cardiac event monitor in people with Atrial Fibrillation New Onset and Myocardial Infarction, run by University of British Columbia at 1 site in Canada.
Trial summary
After a myocardial infarction (MI), patients discharged home in sinus rhythm may develop AF that is asymptomatic, undetected, and undertreated. Previous studies (CARISMA and ARREST) have demonstrate high rates of new-onset AF recorded on implantable loop recorder (ILR), although the routine implantation of ILRs… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation New Onset, Myocardial Infarction
- What is being tested?
- 30-day ambulatory cardiac event monitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2017to 1 Dec 2022
- Phase
- Interventional
- 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
Who may be able to join
- Patients with ST-elevation myocardial infarction (STEMI) or Non-ST-elevation myocardial infarction (NSTEMI; Third Universal Definition of MI) with or without PCI. All patients must have troponin elevation.
- No history of AF during hospitalization, at discharge, or pre-existing AF documented on history (i.e. hospital records, previous hospitalization, ECG records).
- No anticoagulation for AF or other indications (i.e. LV thrombus, heart valves, venous thromboembolism/deep venous thrombosis).
- No concomitant disease expected to reduce expected lifespan to <2 yrs.
Who cannot join
- Patients receiving CABG surgery during this hospitalization or planned cardiac surgery within the next 3 months.
- Patients with spontaneous coronary artery dissection (SCAD), non-atherosclerotic coronary disease (NACAD), and Takotsubo cardiomyopathy are excluded from this study.
- Patients with contraindications to anticoagulation.
- Patients with a chronic skin disorder on the upper torso, or an allergy to medical tape or glue.
Trial locations and contacts
1 site in 1 country.
About this study
After a myocardial infarction (MI), patients discharged home in sinus rhythm may develop AF that is asymptomatic, undetected, and undertreated. Previous studies (CARISMA and ARREST) have demonstrate high rates of new-onset AF recorded on implantable loop recorder (ILR), although the routine implantation of ILRs post-MI remains costly and invasive. The external loop recorder may effectively identify patients with new-onset AF through a validated diagnostic algorithm and targeted monitoring during a high-risk period (immediately after hospital discharge). We will prospectively randomize patients to receive an external loop recorder or standard care, evaluating rates of new-onset AF developing within 30 days after MI.
Read the detailed description
The SIMPL-AF trial will evaluate the role of intensive monitoring after myocardial infarction, assessing for new-onset AF after hospital discharge. Patients will be randomized to receive intensive monitoring or standard care in a 2:1 distribution. Patients randomized to intensive monitoring will receive a SpiderFlash® monitor, worn for 30-days after discharge and returned for analysis.
The primary objective of this study is to evaluate at the incidence of new-onset AF at 30-days post-MI using an intensive monitoring strategy, compared to standard of care. Secondary objectives include the impact of intensive monitoring on oral anticoagulation rates at 90-days and 1-year after monitoring, and the risk factors for developing new-onset AF, and the variables associated with initiating or withholding anticoagulation.
- Being tested
- 30-day ambulatory cardiac event monitor
- Keywords
- atrial fibrillation, myocardial infarction, intensive monitoring, oral anticoagulation, hospitalization
- Medical subject headings
- Myocardial Infarction, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30-day ambulatory cardiac event monitorDiagnostic test
SpiderFlash® 30-day ambulatory cardiac event monitoring will be worn upon discharge.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Monitoring | Experimental | 30-day ambulatory cardiac event monitoir Receives: Diagnostic Test: 30-day ambulatory cardiac event monitor |
| Standard Care | No intervention | Standard Care (no supplemental monitoring) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of new-onset AF at 30-days post-MI
New-onset AF detected through intensive monitoring or standard care (routine assessment)
Measured: 30 days
Secondary outcomes (3)
Rate of oral anticoagulation
Prescription of anticoagulation after intensive monitoring or standard care
Measured: 90 days and 1-year
AF-related hospitalization
Rates of AF-related hospitalization after intensive monitoring or standard care
Measured: 90 days and 1-year
Composite cardiovascular and hospitalization events
All-cause hospitalization, re-infarction, stroke, and death
Measured: 90 days and 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Nov 2017
- Primary completion1 Mar 2022
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation New OnsetStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2:1 enrollment into parallel groups (intensive monitoring vs. standard care).
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Andrade, University of British Columbia
- Investigators
- Jason G Andrade, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345615
- Sponsor's protocol ID
- H17-01060
- Acronym
- SIMPL-AF
- Status last verified
- Aug 2022
- First submitted
- 14 Nov 2017
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Versus Intensive Monitoring After Myocardial Infarction Looking for Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03345615
- Acronym / sponsor ID
- SIMPL-AF / H17-01060
- Keywords
- atrial fibrillation, myocardial infarction, intensive monitoring, oral anticoagulation, hospitalization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 17 Nov 2017 (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.
After a myocardial infarction (MI), patients discharged home in sinus rhythm may develop AF that is asymptomatic, undetected, and undertreated. Previous studies (CARISMA and ARREST) have demonstrate high rates of new-onset AF recorded on implantable loop recorder (ILR), although the routine implantation of ILRs post-MI remains costly and invasive. The external loop recorder may effectively identify patients with new-onset AF through a validated diagnostic algorithm and targeted monitoring during a high-risk period (immediately after hospital discharge). We will prospectively randomize patients to receive an external loop recorder or standard care, evaluating rates of new-onset AF developing within 30 days after MI.
Detailed description
The SIMPL-AF trial will evaluate the role of intensive monitoring after myocardial infarction, assessing for new-onset AF after hospital discharge. Patients will be randomized to receive intensive monitoring or standard care in a 2:1 distribution. Patients randomized to intensive monitoring will receive a SpiderFlash® monitor, worn for 30-days after discharge and returned for analysis.
The primary objective of this study is to evaluate at the incidence of new-onset AF at 30-days post-MI using an intensive monitoring strategy, compared to standard of care. Secondary objectives include the impact of intensive monitoring on oral anticoagulation rates at 90-days and 1-year after monitoring, and the risk factors for developing new-onset AF, and the variables associated with initiating or withholding anticoagulation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2:1 enrollment into parallel groups (intensive monitoring vs. standard care).
| Arm | Type | Receives |
|---|---|---|
| Intensive Monitoring | Experimental | Diagnostic Test: 30-day ambulatory cardiac event monitor30-day ambulatory cardiac event monitoir |
| Standard Care | No intervention | –Standard Care (no supplemental monitoring) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with ST-elevation myocardial infarction (STEMI) or Non-ST-elevation myocardial infarction (NSTEMI; Third Universal Definition of MI) with or without PCI. All patients must have troponin elevation.
- No history of AF during hospitalization, at discharge, or pre-existing AF documented on history (i.e. hospital records, previous hospitalization, ECG records).
- No anticoagulation for AF or other indications (i.e. LV thrombus, heart valves, venous thromboembolism/deep venous thrombosis).
- No concomitant disease expected to reduce expected lifespan to <2 yrs.
Key exclusion criteria (4 listed)
- Patients receiving CABG surgery during this hospitalization or planned cardiac surgery within the next 3 months.
- Patients with spontaneous coronary artery dissection (SCAD), non-atherosclerotic coronary disease (NACAD), and Takotsubo cardiomyopathy are excluded from this study.
- Patients with contraindications to anticoagulation.
- Patients with a chronic skin disorder on the upper torso, or an allergy to medical tape or glue.
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 |
|---|---|---|
| 30-day ambulatory cardiac event monitorSpiderFlash® 30-day ambulatory cardiac event monitoring will be worn upon discharge. | Diagnostic test | Intensive Monitoring |
Primary outcome
Incidence of new-onset AF at 30-days post-MI
Time frame: 30 days
New-onset AF detected through intensive monitoring or standard care (routine assessment)
3 secondary outcomes
Rate of oral anticoagulation
Time frame: 90 days and 1-year
AF-related hospitalization
Time frame: 90 days and 1-year
Composite cardiovascular and hospitalization events
Time frame: 90 days and 1-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- 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.
Jason G Andrade, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 30-day ambulatory cardiac event monitor in people with Atrial Fibrillation New Onset and Myocardial Infarction, run by University of British Columbia at 1 site 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 16 Aug 2022. 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 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?
Results are not available in the source record.
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?
Incidence of new-onset AF at 30-days post-MI (time frame: 30 days). 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 16 Aug 2022.