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

Primary Purpose

Atrial Fibrillation New Onset, Myocardial Infarction

Status

Active

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

30-day ambulatory cardiac event monitor

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation New Onset focused on measuring atrial fibrillation, myocardial infarction, intensive monitoring, oral anticoagulation, hospitalization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Vancouver General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intensive Monitoring

Standard Care

Arm Description

30-day ambulatory cardiac event monitoir

Standard Care (no supplemental monitoring)

Outcomes

Primary Outcome Measures

Incidence of new-onset AF at 30-days post-MI

New-onset AF detected through intensive monitoring or standard care (routine assessment)

Secondary Outcome Measures

Rate of oral anticoagulation

Prescription of anticoagulation after intensive monitoring or standard care

AF-related hospitalization

Rates of AF-related hospitalization after intensive monitoring or standard care

Composite cardiovascular and hospitalization events

All-cause hospitalization, re-infarction, stroke, and death

Full Information

NCT ID

NCT03345615

First Posted

November 14, 2017

Last Updated

August 14, 2022

Sponsor

University of British Columbia

1. Study Identification

Unique Protocol Identification Number

NCT03345615

Brief Title

Standard Versus Intensive Monitoring After Myocardial Infarction Looking for Atrial Fibrillation

Acronym

SIMPL-AF

Official Title

Standard Versus Intensive Monitoring After Myocardial Infarction Looking for Atrial Fibrillation

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 1, 2017 (Actual)

Primary Completion Date

March 1, 2022 (Actual)

Study Completion Date

December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation New Onset, Myocardial Infarction

Keywords

atrial fibrillation, myocardial infarction, intensive monitoring, oral anticoagulation, hospitalization

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

2:1 enrollment into parallel groups (intensive monitoring vs. standard care).

Masking

None (Open Label)

Allocation

Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intensive Monitoring

Arm Type

Experimental

Arm Description

30-day ambulatory cardiac event monitoir

Arm Title

Standard Care

Arm Type

No Intervention

Arm Description

Standard Care (no supplemental monitoring)

Intervention Type

Diagnostic Test

Intervention Name(s)

30-day ambulatory cardiac event monitor

Intervention Description

SpiderFlash® 30-day ambulatory cardiac event monitoring will be worn upon discharge.

Primary Outcome Measure Information:

Title

Incidence of new-onset AF at 30-days post-MI

Description

New-onset AF detected through intensive monitoring or standard care (routine assessment)

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Rate of oral anticoagulation

Description

Prescription of anticoagulation after intensive monitoring or standard care

Time Frame

90 days and 1-year

Title

AF-related hospitalization

Description

Rates of AF-related hospitalization after intensive monitoring or standard care

Time Frame

90 days and 1-year

Title

Composite cardiovascular and hospitalization events

Description

All-cause hospitalization, re-infarction, stroke, and death

Time Frame

90 days and 1-year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jason G Andrade, MD

Organizational Affiliation

University of British Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vancouver General Hospital

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

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Standard Versus Intensive Monitoring After Myocardial Infarction Looking for Atrial Fibrillation

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