Standard Versus Intensive Monitoring After Myocardial Infarction Looking for Atrial Fibrillation

Myocardial Infarction Clinical Trial

— SIMPL-AF  

Official title:

Standard Versus Intensive Monitoring After Myocardial Infarction Looking for Atrial Fibrillation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03345615
• Other study ID #: H17-01060
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: December 1, 2022

Study information

• Verified date: August 2022
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: December 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation New Onset
• Infarction
• Myocardial Infarction

Intervention

Diagnostic Test:
• 30-day ambulatory cardiac event monitor
SpiderFlash® 30-day ambulatory cardiac event monitoring will be worn upon discharge.

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of oral anticoagulation	Prescription of anticoagulation after intensive monitoring or standard care	90 days and 1-year
Secondary	AF-related hospitalization	Rates of AF-related hospitalization after intensive monitoring or standard care	90 days and 1-year
Secondary	Composite cardiovascular and hospitalization events	All-cause hospitalization, re-infarction, stroke, and death	90 days and 1-year