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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive Monitoring | Experimental | 30-day ambulatory cardiac event monitoir |
|
| Standard Care | No Intervention | Standard Care (no supplemental monitoring) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 30-day ambulatory cardiac event monitor | Diagnostic Test | SpiderFlash® 30-day ambulatory cardiac event monitoring will be worn upon discharge. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of new-onset AF at 30-days post-MI | New-onset AF detected through intensive monitoring or standard care (routine assessment) | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of oral anticoagulation | Prescription of anticoagulation after intensive monitoring or standard care | 90 days and 1-year |
| AF-related hospitalization | Rates of AF-related hospitalization after intensive monitoring or standard care |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason G Andrade, MD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver General Hospital | Vancouver | British Columbia | V5Z 1M9 | Canada |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 19, 2017 | Nov 13, 2017 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 6, 2017 | Nov 13, 2017 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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2:1 enrollment into parallel groups (intensive monitoring vs. standard care).
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| 90 days and 1-year |
| Composite cardiovascular and hospitalization events | All-cause hospitalization, re-infarction, stroke, and death | 90 days and 1-year |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D001145 | Arrhythmias, Cardiac |