Standard Versus Intensive Monitoring After Myocardial Infarction Looking for Atrial Fibrillation (SIMPL-AF)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myocardial Infarction; Atrial Fibrillation New Onset
• Intervention / Treatment: Diagnostic test: 30-day ambulatory cardiac event monitor

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 Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intensive Monitoring; 30-day ambulatory cardiac event monitoir	Diagnostic test: 30-day ambulatory cardiac event monitor; SpiderFlash® 30-day ambulatory cardiac event monitoring will be worn upon discharge.
No Intervention: Standard Care; Standard Care (no supplemental monitoring)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	90 days and 1-year
Composite cardiovascular and hospitalization events	All-cause hospitalization, re-infarction, stroke, and death	90 days and 1-year

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Jason G Andrade, MD, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): March 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: November 14, 2017
• First Submitted That Met QC Criteria: November 14, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 14, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: atrial fibrillation; myocardial infarction; hospitalization; oral anticoagulation; intensive monitoring
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arrhythmias, Cardiac; Myocardial Infarction; Infarction; Atrial Fibrillation
• Other Study ID Numbers: H17-01060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No