Standard Versus Intensive Monitoring After Myocardial Infarction Looking for Atrial Fibrillation
Phase: NA
Conditions: Atrial Fibrillation New Onset, Myocardial Infarction
Sponsor: University of British Columbia

SIMPL-AF Study 
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Standard versus Intensive Monitoring Post-Myocardial 
Infarction Looking for New-Onset Atrial Fibrillation 
(SIMPL-AF) 
 
 
Version number 1.8 
2017/09/19 
 
 
Investigator 1 
 
Jason G. Andrade, MD, FRCPC, FHRS 
Director, Atrial Fibrillation Clinic, Electrodiagnostics, and 
Cardiac Electrophysiology 
 
 
 
 
Division of Cardiology, University of British Columbia 
 
 
 
 
Vancouver General Hospital Diamond Health Care Centre 
 
 
 
 
9th Floor, 2775 Laurel Street 
 
 
 
 
Vancouver, BC V5Z 1M9  
 
 
 
 
Email: Jason.andrade@vch.ca 
 
Investigator 2 
 
Christopher C. Cheung, MD, BSc. (Hons) 
PGY-4 Cardiology 
 
 
 
 
Division of Cardiology, University of British Columbia 
Vancouver General Hospital Diamond Health Care Centre 
9th Floor, 2775 Laurel Street 
Vancouver, BC V5Z 1M9 
Email: CCheung@alumni.ubc.ca 
 
Co-Investigators 
 
Kenneth G. Gin, MD, FRCPC 
 
 
 
 
Head, VGH Division of Cardiology 
 
 
 
 
Division of Cardiology, University of British Columbia 
Vancouver General Hospital Diamond Health Care Centre 
9th Floor, 2775 Laurel Street 
Vancouver, BC V5Z 1M9 
 
 
 
 
Email: Kenneth.Gin@vch.ca 
 
Andrew D. Krahn MD, FRCPC, FHRS 
Professor of Medicine and Head UBC Division of Cardiology, 
Vancouver General Hospital Diamond Health Care Centre 
and St. Paul’s Hospital Davie Street Clinic, 1033 Davie St  
Vancouver BC V6E 1M7 
 
 
 
 
 
Email: akrahn@mail.ubc.ca 
 

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Marc W. Deyell, MD, FRCPC, FHRS 
 
 
 
 
Director, Heart Rhythm Research 
 
 
 
 
Director, Electrophysiology Lab, St. Paul’s Hospital 
 
 
 
 
Division of Cardiology, University of British Columbia 
 
 
 
 
Heart Rhythm Services, St. Paul’s Hospital 
 
 
 
 
211-1033 Davie St 
 
 
 
 
Vancouver, BC V6E 1M7 
 
 
 
 
Email: MDeyell@providencehealth.bc.ca 
 
Research Managers: 
Jackie Chow, BSN 
 
 
 
 
Cardiology Research Manager 
 
 
 
 
VCH/UBC Cardiology Research 
 
 
 
 
Division of Cardiology, University of British Columbia 
Vancouver General Hospital Diamond Health Care Centre 
9th Floor, 2775 Laurel Street 
Vancouver, BC V5Z 1M9 
 
 
 
 
Email: Jackie.chow@vch.ca 
 
 
 
 
 
Andrew Starovoytov, MD, CCRP 
 
 
 
 
Clinical Research Coordinator 
 
 
 
 
VCH/UBC Cardiology Research 
 
 
 
 
Division of Cardiology, University of British Columbia 
Vancouver General Hospital Diamond Health Care Centre 
9th Floor, 2775 Laurel Street 
Vancouver, BC V5Z 1M9 
 
 
 
 
Email: a.starovoytov@ubc.ca 
 
Operations Manager:  
Faisal Aziz, BHSc, MHA 
 
 
 
 
Operations Manager 
 
 
 
 
 
 
 
Division of Cardiology, University of British Columbia 
Vancouver General Hospital Diamond Health Care Centre 
9th Floor, 2775 Laurel Street 
Vancouver, BC V5Z 1M9 
 
 
 
 
Email: Faisal.Aziz@vch.ca 
 
 

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1. BACKGROUND: 
Patients with atrial fibrillation (AF) who suffer an acute myocardial infarction (MI) are at 
increased risk for stroke (2% during index hospitalization), and mortality (14% 30-day 
mortality and 22% 1-year mortality) compared to those without AF.1 In the TRACE trial, 
post-MI patients with AF during hospitalization had an increased 5-year mortality 
compared to those without AF (56%, OR 1.5).2 Furthermore, AF post-MI has been 
associated with 30-day (HR 14.6) and long-term stroke (HR 2.29, mean follow-up 2.7 
years).3 Even transient AF in hospital has been associated with stroke at 1-year (10.2%, 
HR 5.1), thus representing a target for therapeutic intervention4 In this study, patients 
were discharged home with only single or dual antiplatelet therapy despite eligibility for 
anticoagulation (mean age 70 years, 53% hypertensive, 34% diabetic). Thus, after an 
MI, AF is an important prognostic factor for predicting future events, including stroke 
and death. 
 
1.1 New-Onset AF Post-MI 
The prevalence of new AF post-MI is variably reported, with previous trial data reporting 
new AF in 3-7% of patients after extended follow-up (2-4 years).2, 3 A community cohort 
using ECG records identified new AF in 3.7% 3-30 days post-MI, and in 12% after long-
term follow-up (6.6 years). However, despite the prevalence of AF, the majority of these 
episodes are asymptomatic, as demonstrated in two recent studies using continuous 
monitoring via implantable cardiac monitors. The first study (CARISMA) enrolled post-
MI patients with LV dysfunction (EF ≤40%) but no history of AF. The investigators 
demonstrated the risk of developing new AF was highest in the first 2 months post-MI 
(16%), with the prevalence of new-onset AF increasing to 28% at approximately 2 years 
follow-up.5 The ARREST study enrolled 50 post-STEMI patients with LVEF ≥40% who 
received percutaneous revascularization (PCI) within 7 days following MI.6 Over a 2-
year follow-up, AF was newly detected in 58% of the study population, with a median 
time to first episode of 4.8 months. Importantly, in both these studies >90% of patients 
were unaware of their AF highlighting the importance of vigilant surveillance of cardiac 
rhythm. As such a substantial proportion of patients may have undiagnosed AF and 
remain at increased risk of stroke.5, 6  
 
1.2 Limitations of Current Studies 
A major difference between the aforementioned CARISMA and ARREST studies has to 
do with the method of surveillance. The CARISMA study utilized a loop recorder with an 
older AF detection algorithm that was reliant on ventricular rate. Specifically, AF was 
only detected at high heart rates (≥125 bpm) or in the presence of severe bradycardia 
(≤30 bpm). As many post-MI patients receive rate-slowing medications it is possible that 
they may not develop AF within the detection zones, and thus the prevalence estimate 
in this study likely represents an underestimate.7 Using an improved detection algorithm 
(R-R interval assessment), the ARREST study identified a greater proportion of new 
onset AF in a potentially healthier population (LVEF ≥40%). However, in order to 
document this prevalence, patients were required to undergo an invasive procedure. 
The routine implantation of implantable loop recorders (ILRs) post-MI remains 
prohibitive due to its high cost and semi-invasive nature. 
 

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External loop recorders may fit the ideal niche for AF monitoring in post-MI patients. As 
relatively affordable devices, external loop recorders provide extended monitoring and is 
best suited for patients with arrhythmia recurrence within 3-4 weeks.8 Furthermore, in 
contrast to patient activated external monitors (event recorders), external loop recorders 
have diagnostic rhythms for intelligent analysis and identification of AF, thus making the 
an ideal method to detect AF in asymptomatic patients, These devices have been used 
in syncope work-up and evaluation of palpitations, and more recently in the prolonged 
monitoring of cryptogenic stroke with great success.9 A non-invasive but intensive 
monitoring strategy post-MI may effectively identify individuals who develop AF after 
discharge and are eligible for oral anticoagulation (OAC). 
 
1.3 Targets for intervention 
Dual antiplatelet therapy (DAPT), is routinely prescribed to patients after an acute 
coronary syndrome owing to its beneficial effects in the prevention of stent thrombosis, 
myocardial infarction, and death after acute coronary syndrome (ACS).10-14 
Unfortunately in the AF population, DAPT is inferior to OAC in the prevention of 
thromboembolic complications associated with atrial fibrillation or flutter (AF/AFL).15-17 
As such, the identification of AF in this population has the potential to significantly alter 
the clinical management of these patients, as well as potentially improve outcomes. 
 
 
2. RATIONALE: 
After an 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 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). 
 
 
3. PROPOSED RESEARCH 
3.1 Hypothesis 
Using a non-invasive but intensive monitoring strategy (30-day external loop recorder), 
we hypothesize that AF will be detected more frequently compared to standard care. 
Furthermore, intensive monitoring will result in higher rates of oral anticoagulation 
prescription (secondary outcome) compared to standard care. 
 
3.2 Objectives 
1) Primary Objective - To determine the incidence of new-onset AF at 30-days post-
MI using an intensive monitoring strategy. 
2) Secondary Objectives 
a) To determine the impact of intensive monitoring on oral anticoagulation rates at 
90-days and 1-year after monitoring. 
b) To identify the risk factors for developing new-onset AF (i.e. demographics, MI 
characteristics, GRACE score). 

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c) To determine the variables associated with initiating or withholding 
anticoagulation in new-onset AF (i.e. CHADS2, CHA2DS2-VASc, HASBLED 
scores). 
 
3.4 Inclusion Criteria 
1) Age 18 years or older. 
2) Patients with ST-elevation myocardial infarction (STEMI) or Non-ST-elevation 
myocardial infarction (NSTEMI; Third Universal Definition of MI18) with or without 
PCI. All patients must have troponin elevation. 
3) No history of AF during hospitalization, at discharge, or pre-existing AF documented 
on history (i.e. hospital records, previous hospitalization, ECG records). 
4) No anticoagulation for AF or other indications (i.e. LV thrombus, heart valves, 
venous thromboembolism/deep venous thrombosis). 
5) No concomitant disease expected to reduce expected lifespan to <2 yrs. 
 
3.5 Exclusion Criteria 
1) Patients receiving CABG surgery during this hospitalization or planned cardiac 
surgery within the next 3 months. 
2) Patients with spontaneous coronary artery dissection (SCAD), non-atherosclerotic 
coronary disease (NACAD), and Takotsubo cardiomyopathy are excluded from this 
study. 
3) Patients with contraindications to anticoagulation. 
4) Patients with a chronic skin disorder on the upper torso, or an allergy to medical tape 
or glue. 
 
3.6 Outcomes 
1) Primary Outcome: development of atrial fibrillation or flutter lasting ≥30 seconds 
(consensus definition19, 20) detected using external loop recorder 
2) Secondary Outcome: anticoagulation prescription, AF-related hospitalization, and a 
composite secondary outcome of all-cause hospitalization, re-infarction, stroke, and 
death at 90-days and 1-year after completion of monitoring 
 
3.7 Methods 
Upon enrollment, patients will be randomized (2:1 distribution for intensive monitoring, 
stratified by STEMI vs. NSTEACS) to receive standard care or intensive monitoring. 
Intensive monitoring entails wearing a Spiderflash (LivaNova) 30-day external cardiac 
monitor at discharge. A 30-day external cardiac monitor represents the most feasible, 
high-quality, non-invasive monitoring strategy possible, while maximizing the duration of 
uninterrupted monitoring beginning at discharge. Demographics, clinical characteristics, 
and risk factors for stroke and bleeding (i.e. CHADS2, HASBLED) will also be collected 
at enrollment. 
 
The research team will perform all aspects of SpiderFlash data acquisition and 
interpretation. The research team has purchased the SpiderFlash devices and the 
programming/analysis software. After patients have completed the 30-day recording, 
the information will be downloaded directly off the device (via SD card). There is no 

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industry involvement and no data transfer to a server or out of country. There is no 
relationship between the SpiderFlash provider and UBC/VCH, and no connection 
between the research team and SpiderFlash provider. All funds are provided by a 
research award attained by the trainee (CC). 
 
Spiderflash ECGs will be interpreted by the trainee (CC, cardiology resident) with 
oversight from the supervising physician (JA). The reports will be distributed to the 
primary cardiologist and family physician. The standard care strategy includes a 12-lead 
ECG performed prior to discharge and at follow-up with the primary cardiologist 
(typically 4-8 weeks post-MI). 
 
Cardiac medication review will be performed by the trainee (CC) at 90-days and 1-year 
post-monitoring (to allow adequate time for anticoagulant initiation). A telephone follow-
up (15 min) and chart review will confirm anticoagulation status, and reasons for 
initiating or withholding anticoagulation. 
 
Both the intensive monitoring and control groups will receive telephone follow-up at 90-
days to assess prescription status. No additional care or clinic visits are scheduled for 
the control group. All additional data (including ECGs performed by primary cardiologist 
and confirmation of anticoagulation status) in the intervention and control group will be 
performed via electronic chart review of Cardiology EMR. 
 
3.8 Sample Size Calculations and Statistical Analysis 
Previous retrospective and cohort data has identified new-onset AF in 7-14% of patients 
in-hospital or within 2 days after MI.4, 21 Between 3-30 days, new AF occurs in 3.7% 
when ascertained through an electronic ECG database, with the remainder of AF (12%) 
developing during long-term follow-up (6.6 years).21 Thus, at 30-days post-MI, we 
anticipate that the standard care strategy will detect similar rates of AF to this cohort 
study (3.7%).  
 
Using an ILR, new-onset AF was detected in 16% at 2-months (approx. 8% at 1-month, 
CARISMA).5 However, in the CARISMA study, AF was only detected when HR ≥125 
bpm, effectively missing AF at slower rates (<125 bpm).5 Up to half of patients (49%) 
with AF post-MI have heart rates ≤94 bpm.7 Thus, we anticipate that an intensive 
monitoring strategy (30-day external cardiac monitor) will detect higher rates of AF 
(16%) after 30-days (double ILR rate given the heart rate limitations). 
 
With a 2:1 randomization to intensive monitoring and using a 5% significance level 
(α=0.05), 216 patients (144 patients with intensive monitoring and 72 patients with 
standard care) are required to have a 80% power (1-β=0.80) of detecting an increase in 
new AF (primary outcome) from 3.7% (standard care) to 16% (intensive monitoring). 
Accounting for a 5% drop-out, the final sample size is 240 patients (120 patients per 
group).  
 
Statistical analysis will be performed using an intention-to-treat analysis for patients 
randomized to the intensive monitoring or standard care strategy. Regression analysis 

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will be used to compare rates of AF at 30-days between both groups. Time-to-event 
analysis will be used to compare the time to development of AF in both groups. 
 
 
4. FEASIBILITY 
4.1 Recruitment 
There are approximately 310 STEMI/year in the health region (308-341/year, regional 
data22) with at least 4 NSTEACS per 1 STEMI (1240 NSTEACS/year, including 
transfers, regional data23). Patients will be excluded based on LVEF>40% (66% 
ineligible24), pre-existing AF (9%21), in-hospital AF (14%4), LV thrombus (8%25), and 
other factors (i.e. heart valves/VTE; uncommon, ≤1%26). 368 patients/year will meet 
enrollment eligibility. Using an enrollment rate of 66%, 20 patients will be enrolled per 
month (10 for intensive) and the target (264 patients) will be met in 13 months. 
 
Patient recruitment will be overseen by Cardiology Research Manager, Jackie Chow, 
and Cardiology Clinical Research Coordinator, Andrew Starovoytov. 
 
Patients will be recruited directly from the Vancouver General Hospital Coronary Care 
Unit (CCU). The Cardiology research nurses (Andrew Starovoytov and Jackie Chow) 
routinely screen patients admitted to the CCU for study eligibility. This process is well-
established for a number of ongoing studies that operate in the CCU. 
 
In this study, prospective participants will be identified upon admission to the CCU 
meeting the eligibility criteria. Study participants will be approached by Andrew and 
Jackie for consent to participate in the study. 
 
4.2 Randomization and Blinding 
Patients will be recruited from the Vancouver General Hospital Cardiac Care Unit (CCU) 
and St. Paul’s Hospital Cardiac Intensive Care Unit (CICU). Randomization will be 
performed using a central randomization system (integration through RedCap) in a 1:1 
manner, and will be implemented using an online access (RedCap) system. A back-up 
randomization will be available through sealed envelope in case of database issues. 
The allocation sequence will be generated by the co-investigator and Database expert 
(AS). Patients will not be blinded to the monitoring device. Physicians will blinded to 
patient identity, but will only review results for patients that received the monitoring 
device. 
 
4.3 Device Purchase and Interpretation 
The investigator and co-investigators have met with industry to purchase the 
SpiderFlash devices for specific use in this study. A reduced price for 10 SpiderFlash 
devices ($1150.00) was negotiated and the devices have been purchased, with delivery 
expected in May 2017. 
 
SpiderFlash device interpretation will be performed initially by technicians that are 
working with the software for other clinical services. Technician interpretation of the 
SpiderFlash will be overseen by Operations Manager, Faisal Aziz. Technician reports 

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are subsequently reviewed by the investigator and co-investigator, blinded to patient 
demographics and details. All reports will be sent to the primary cardiologist for all 
enrolled patients. 
 
4.4 Potential Issues and Mitigating Strategies 
1) Patients may develop AF in-hospital and revert to sinus rhythm prior to 
discharge: these patients are excluded (AF already diagnosed, no role for 
intensive monitoring as per primary outcome). 
2) Impact on anticoagulation: all test results will be communicated with the primary 
cardiologist and family physician. This study does not prescribe anticoagulation 
and will not influence the prescribing physicians- rather, all information will be 
communicated to the primary cardiologist or family physician. 
3) Impact on stroke: this pilot study allows for the planning of a subsequent 
intervention with cardiovascular endpoints. 
 
4.5 CCS-Bayer Resident Vascular Award and Funding 
This project is co-led by a trainee (CC) and received full funding and won first prize at 
the CCS-Bayer Resident Vascular Award trainee competition in October 2016, receiving 
$30,000 funding ($20,000 + $10,000 presentation bonus). There is significant motivation 
to support this project from a local and divisional level, including commitment from 
various faculty and research staff at Vancouver General Hospital. 
 
 
 
 
 
 
 
4.6 Research Infrastructure 
The coordinating centre is the UBC Division of Cardiology, Cardiology Research at 
Vancouver General Hospital (located at Gordon and Leslie Diamond Health Care 
Centre). This research project will be performed at two sites in British Columbia with 
supervisors at each site (Vancouver General Hospital: JA, KG; St. Paul’s Hospital: AK, 
MD). Each site benefits from a large referral base for STEMI and NSTEACS from 
across the province. There is established research support for the screening and 
enrollment of patients (research nurses are supportive). This project is financially 
supported by the UBC Division of Cardiology, with divisional research funds (CAPP) to 
support the purchase and donation of 10 Spiderflash monitors to this project. 
 
The steering committee includes the principal investigator and co-investigators listed in 
this application. Enrollment will be performed by the Cardiology Research staff (AS, JC) 
and trainee (CC). The endpoint adjudication committee will be attend through 
consensus of the principal investigator (JA) and trainee (CC). The data management 
team will include the co-investigator (AS) with expertise in data management and 
RedCap Database development and the trainee (CC). 
 
The trainee (CC) leading this project has significant research experience, and has 
participated in multiple prospective and retrospective projects in the field. He has written 
a review of loop recorders in syncope, and is writing a review of novel technologies for 
detecting AF. He has received multiple awards, including from the Canadian Stroke 
Prevention Intervention Network (C-SPIN) and the Cardiac Arrhythmia Network of 
Canada (CANet), and twice attended the C-SPIN Annual Clinical Trials workshop. The 

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supporting mentor and supervisors have extensive experience in clinical trials and AF 
research, and the trainee has collaborated with them on various occasions. Together, 
these supports and experiences provide an exceptional research environment for the 
design, coordination, and completion of this research project. 
 
4.7 Research Database Development 
The investigators will be using a RedCAP database for the storage of all patient 
information, including demographics, baseline, and follow-up variables collected in the 
case report forms. The RedCap system will provide anonymization and generate unique 
study ID numbers for all participants in this study. The RedCAP system is used in 
several site-specific and multicenter studies at the University of British Columbia, and 
will be managed by Clinical Research Coordinator, Andrew Starovoytov. Data will be 
entered by the principal investigator (JA), co-investigator (CC, AS). Access to the final 
trial dataset will include the principal investigator and all co-investigators. 
 
4.8 Data Monitoring Committee 
The Data Monitoring Committee includes two co-investigators that will not be involved in 
data collection or analysis (AK, KG). The Data Monitoring Committee will review the 
status of the trial every 6 months to ensure no difference in outcomes including mortality 
or re-hospitalization between the intensive monitoring and control groups. Stopping 
guidelines include an excess of mortality (2x) in either group. The Data Monitoring 
Committee will make the final decision to terminate the trial. 
 
4.9 Ethical Considerations 
The ethics application for this underway. The complete study protocol has been 
submitted and received initial review from the UBC/Vancouver Coastal Health Clinical 
Research Ethics Board (CREB). All data collection sheets and patient consent forms 
have been submitted and included in the appendix of this application. 
 
Protocol modifications will be submitted as soon as possible to the ethics 
committee/institutional review board for approval. The principal investigator or trainee 
will inform all co-investigators in the event of any protocol modifications. 
 
This project will be conducted in compliance with the protocol and principles laid down 
in the Declaration of Helsinki, Good Clinical Practice (GCP), as defined by the 
International Conference on Harmonization (ICH) where applicable, along with all other 
local regulatory requirements. Before study initiation, the enrolling center must have 
written and received approval/favorable opinion from the Institutional Review 
Board/Independent Ethics Committee (IRB/IEC) for the protocol, and data collection 
forms. 
 
4.10 Publication and Presentation 
Once completed, the investigators will communicate trial results with participants 
through publication. Publication and manuscript preparation will involve the principal 
investigator and all co-investigators. There are no anticipated publication or 
presentation restrictions. 
 

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APPENDICES. 
APPENDIX 1. Enrollment Case Report Form. 
 
DEMOGRAPHICS 
 
Study Site 
       
 
 
 
 
        (VGH = 1; SPH = 2) 
 
 
Study ID 
       
 
 
 
 
 
 
 
Year/Month of Birth        
 
 
 
  
 
 
 
       (YYYY-MM)  
 
 
 
 
 
 
 
 
 
Gender  
 
 Female   
 Male 
 
Age at enrolment (years): 
       
 
  
 
Date of Enrollment 
       
 
 
 
 
 
      (YYYY-MM-DD)  
 
Signature of Person Completing CRF  
       
 
 
Date:        
 
 
 
INCLUSION CRITERIA (patient must meet all criteria to be eligible for study) 
1) Age 18 years or older. 
2) Patients with ST-elevation myocardial infarction (STEMI) or Non-ST-elevation myocardial 
infarction (NSTEMI; Third Universal Definition of MI18) with or without PCI. All patients must 
have troponin elevation. 
3) No history of AF during hospitalization, at discharge, or pre-existing AF documented on history (i.e. 
hospital records, previous hospitalization, ECG records). 
4) No anticoagulation for AF or other indications (i.e. LV thrombus, heart valves, venous 
thromboembolism/deep venous thrombosis). 
5) No concomitant disease expected to reduce expected lifespan to <2 yrs. 
 
EXCLUSION CRITERIA 
1) Patients receiving CABG surgery during this hospitalization or planned cardiac surgery within the 
next 3 months. 
2) Patients with spontaneous coronary artery dissection (SCAD), non-atherosclerotic coronary disease 
(NACAD), and Takotsubo cardiomyopathy are excluded from this study. 
3) Patients with contraindications to anticoagulation. 
4) Patients with a chronic skin disorder on the upper torso, or an allergy to medical tape or glue. 
 
PATIENT MEETS ALL INCLUSION AND EXCLUSION CRITERIA: 
 
 
Signature of Investigator: 
       
 
 
 
Date:        
 
 
 

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PAST MEDICAL HISTORY 
Hypertension  
 
 
 
 
 YES 
 NO 
 
 
 
 
 
 
 
 
 
 
Diabetes 
 
 
 
 
 
 YES 
 NO 
 
 
 
If yes, Type? 
 
 
 
 
 Type 2 
 Type 1 
 
 
 
Insulin-use 
 
 
 
 
 YES 
 NO 
 
 
 
Dyslipidemia  
 
 
 
 
 YES 
 NO 
 
 
Coronary Disease (before enrolment)  
 
 YES    
 NO 
 
Prior MI 
 
 
 
 
 YES    
 NO 
 
Prior PCI 
 
 
 
 
 YES   
 NO 
 
 
Date of Last MI/PCI:        
 
 
 
 
 
 
 
 
 
 
(YYYY-MM)   
 
 
 
 
 
 
 
 
Prior CABG 
 
 
 
 
 YES   
 NO 
 
Date of CABG: 
       
 
 
 
 
 
 
 
 
 
 
(YYYY-MM)   
 
 
 
 
 
 
 
Heart Failure (prior to enrolment ACS) 
 
 YES    
 NO 
 
 
Ejection Fraction (EF): 
 
 
 Reduced EF (HFrEF, LVEF <40%) 
 
 
 
 
 
 
 
 Preserved EF (HFpEF, LVEF >40%) 
 
If Reduced EF, last documented EF before current MI: 
       
 
% 
 
 
 
 
Prior Stroke/CVA 
 
 
 
 
 YES   
 NO 
If so, what type? 
 
 
 
 Ischemic    
 Hemorrhagic 
 
 
 
 
 
 
 
 TIA 
 Other 
 
How many strokes? 
       
 
 
 
Most recent stroke: 
       
 
 
 
 
 
 
 
       (YYYY-MM) 
Carotid Artery Disease  
 
 
 
 YES 
 NO 
Peripheral Vascular Disease 
 
 
 
 YES 
 NO 
(i.e. femoral, aortic aneurysm including AAA, TAA) 
 
Renal Disease (i.e. GFR <60 mL/min)  
 
 YES 
 NO 
 
GFR at enrollment:  
       
 
 mL/min 
 
Liver Disease (i.e. documented cirrhosis)  
 
 YES   
 NO 
 
Thyroid Disease 
 
 
 
 
 YES    
 NO 
If yes, on replacement? 
 
 
 YES 
 NO 
Last TSH 
 
       
 
 
 
 
Date of Last TSH 
       
 
 
 
       (YYYY-MM) 
 
Cancer/Malignancy 
 
 
 
 
 YES   
 NO 
If so, type and stage (if available): 
       
 
 
 
 
Active Cancer? (i.e. treatment within past 6 months) 
 YES    
 NO 
 

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SOCIAL HISTORY 
Smoking history: 
 
 
 
 
 YES    
 NO 
 
 
Current smoker 
 
 
 
 YES    
 NO 
  
 
If quit, date: 
 
      
 
  
 
 
 
       (YYYY-MM) 
Years smoked:  
       
 
 
 
 
Regular Alcohol Use  
 
 
 
 YES 
 NO 
 
Drinks per week:  
       
 
 
 
 
Illicit Drug Use 
 
 
 
 
 YES    
 NO 
 
Drugs used:  
 
       
 
 
 
 
CURRENT MYOCARDIAL INFARCTION 
Date of MI 
 
 
       
 
 
 
 
 
 
 
 
 
 
       (YYYY-MM) 
 
Date of Admission 
 
       
 
 
 (if different from date of MI) 
 
 
 
 
 
       (YYYY-MM) 
 
Type of MI 
 
 
 
 
 STEMI    
 NSTEMI 
 
 
 
 
 
 
 
 
 
 
LVEF ≤ 40%  
 
 
 
 
 YES   
 NO  
On left ventriculogram 
 
 
 YES    
 NO 
 
 
On echocardiogram 
 
 
 
 YES    
 NO 
 
 
 
Other modality:  
       
 
 
 
 
 
Lowest LVEF measured 
       
 
 % 
 
Modality used:  
 
 LVgram 
 Echo 
 Other:       
 
 
 
 
CORONARY ANGIOGRAM 
Cath Performed? 
 
 
 YES    
 NO 
 
Date of Cath  
       
 
 
 
 
 
 
 
 
       (YYYY-MM) 
 
PCI performed 
 
 YES   
 NO 
 
Number and location of stent(s) 
       
 
 
 
 
Type of stents   
 
 DES   
 
 BMS 
 
Number of vessels with disease (≥70%) 
 
 single-vessel   
 two-vessel 
 three-vessel    
 left main 
 prior CABG 
 
ECHOCARDIOGRAM (closest to discharge) 
 
  
Echo Performed? 
 
 
 YES    
 NO 
 
 
Date of Last Echo 
       
 
 
 
 
  
 
 
 
 
 
       (YYYY-MM) 
Valvular abnormalities (please describe)  
 
 
       
 
 
 
 
 
 
 
       
 
 
 
 
 
 
 

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Left atrial size and dimensions  
 
 
 
Volume (indexed) 
       
 
 
 
 
 
Dimension 
 
       
 
 
 
 
 
 
 
OTHER RELEVANT INVESTIGATIONS 
(i.e. if patient had another imaging modality to document LV dysfunction) 
 
       
 
 
 
 
 
 
 
       
 
 
 
 
 
 
 
ARRHYTHMIAS 
Ventricular arrhythmias 
 
 YES    
 NO 
 
If yes, shocked? 
 
 YES    
 NO 
 
Did patient have cardiac arrest?  
 YES    
 NO 
(either out-of-hospital or in-hospital cardiac arrest)  
 
 
CARDIAC MEDICATIONS 
Please list medications on discharge prescription (or as close to discharge as possible) 
 
Antiplatelet(s)  
 ASA  
 Clopidogrel 
 Ticagrelor  
 Prasugrel 
 
Beta-blocker 
 
 YES, name:        
 
 
 NO 
 
ACE Inhibitor  
 YES, name:        
 
 
 NO 
 
ARB 
 
 
 YES, name:        
 
 
 NO 
 
MRA  
 
 YES, name:        
 
 
 NO 
 
Diuretic 
 
 YES, name:        
 
 
 NO 
 
Statin  
 
 YES, name:        
 
 
 NO 
 
Other medications 
 Hydralazine 
 
 Nitrates (i.e. isosorbide dinitrate, 
 
 
 
 Sacubitril/valsartan 
      isosorbide mononitrate, nitro patch) 
 Ivrabradine  
 
 Others:       
 
 
 
 
 
 
*Please contact Chris Cheung (email: ccheung@alumni.ubc.ca, phone: 604-715-8173, pager: 604-707-3086) 
or Dr. Jason Andrade (jason.andrade@vch.ca) with questions surrounding enrollment or eligibility. 
 
 

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APPENDIX 2. Follow-up Case Report Form. 
 
Study Site 
       
 
 
 
Study ID 
       
 
 
 
 
        (VGH = 1; SPH = 2) 
 
Date of Follow-up 
       
 
 
Which period?  
 3-month 
 1-year  
 
 
 
       (YYYY-MM) 
Alive at Follow-up 
 YES   
 NO, cause of death:  
       
 
 
 
 
 
 
 
 
 
       date of death: 
       
 
 
 
 
 
 
 
 
 
 
 
 
 
      (YYYY-MM) 
 
Signature of Person Completing CRF  
       
 
 
Date:        
 
 
 
ANTIPLATELET/ANTICOAGULANT PRESCRIPTION 
Antiplatelet 
 
 ASA  
 Clopidogrel 
 Ticagrelor  
 Prasugrel 
 
Anticoagulant  
 YES, name:        
 
 
 NO 
 
 
 
 
   dose:         
 
 
 
 
CLINICAL OUTCOMES (since enrollment or last follow-up) 
Myocardial Infarction  
 
 YES    
 NO 
 
With PCI 
 
 
 YES    
 NO 
 
 
Date of Last MI/PCI:        
 
 
 
 
 
 
 
 
 
 
(YYYY-MM)   
 
 
 
 
 
 
 
With CABG 
 
 
 YES    
 NO 
 
 
Date of CABG: 
       
 
 
 
 
 
 
 
 
 
 
(YYYY-MM)   
 
 
 
 
 
 
 
 
 
Stroke/CVA  
 
 
 YES   
 NO 
If so, what type? 
 
 Ischemic    
 Hemorrhagic 
 TIA 
 Other 
 
Date of Stroke/CVA:        
 
 
 
 
 
 
 
 
 
 
(YYYY-MM)   
 
 
 
 
 
 
 
Atrial Fibrillation (patient reported) 
 YES   
 NO 
 
Symptomatic?  
 
 YES   
 NO 
 
If symptomatic, number of episodes:        
 
  
Cardiac Arrest  
 
 
 YES   
 NO 
 
Date of cardiac arrest:        
 
 
 
 
 
 
 
 
 
 
(YYYY-MM)   
 
 
 
 
 
 
 
Re-hospitalization (since discharge 
 YES   
 NO 
or last-follow-up) 
 
Reason for re-hospitalization 
 Stroke    
 MI  
 Heart Failure 
 
 
 
 
 
 Other:       
 
 
 
 
Date of re-hospitalization: 
       
 
 
 
 
 
 
 
 
 
(YYYY-MM)   
 
 
 
 
 
 
 
 

SIMPL-AF Study 
Version 1.8, September 19, 2017 
Page 15 of 22 
Emergency Room Visits (without hospitalization, since discharge or last follow-up) 
  
 YES   
 NO 
 
Reason for ER Visit 
 
 Cardiac (i.e. chest pain, shortness of breath, palpitations) 
 
 
 
 
 
 Other:       
 
 
 
 
 
INVESTIGATIONS (since discharge or last follow-up) 
ECHOCARDIOGRAM 
 
  
Echo since discharge/last follow-up? 
 YES    
 NO 
 
 
Date of Last Echo 
       
 
 
 
 
  
 
 
 
 
 
       (YYYY-MM) 
 
LV ejection fraction:  
       
 
 
% 
Change in LV function: 
 Increase    
 Decrease 
 
 
PATIENT SATISFACTION 
(Complete at 3 month follow-up if patient received the intensive monitoring strategy) 
Did the patient complete full duration of monitoring (30 days)? 
 
 
 
 
 
 YES    
 NO 
 
 
If not, how many days? 
       
 
 
 
Please rate the comfort of wearing the SpiderFlash device (score from 1-10, 10 is very comfortable) 
 
Rating (1 to 10) 
       
 
 
 
 
If not comfortable why not?        
 
 
 
Did the patient have any difficulty using the device? 
 
 
 
 
 
 YES    
 NO 
 
 
What difficulties? 
       
 
 
 
 
Does the patient prefer intensive monitoring over no monitoring? 
 
 
 Prefers intensive monitoring    
 Prefers less monitoring 
 
Why or why not? 
       
 
 
 
 
Did the patient feel satisfied with the care they received as part of the study? 
Please rate your satisfaction (score from 1-10, 10 is very satisfied). 
 
Rating (1 to 10) 
       
 
 
 
 
If not satisfied, why not? 
       
 
 
 
 
 
 
*Please contact Chris Cheung (email: ccheung@alumni.ubc.ca, phone: 604-715-8173, pager: 604-707-3086) 
or Dr. Jason Andrade (jason.andrade@vch.ca) with questions surrounding enrollment or eligibility.

SIMPL-AF Study 
Version 1.8, September 19, 2017 
Page 16 of 22 
APPENDIX 3. STUDY CONSENT FORM. 
                                                                                             
 
Participant Information and Consent Form 
 
 
Protocol Title:                    
Does Intensive Monitoring Improve Diagnosis and Treatment of 
Atrial Fibrillation after Myocardial Infarction (SIMPL-AF)   
 
Principal Investigator: 
Dr. Jason G Andrade 
 
Co-investigators: 
Doctors: Christopher C. Cheung, Kenneth G. Gin, Andrew D. 
Krahn, Marc W. Deyell. Research Managers: Jackie Chow and 
Andrew Starovoytov. Operations Manager: Faisal Aziz. All 
investigators are members of the Vancouver Hospital Division of 
Cardiology and the Department of Medicine of the University of 
British Columbia (UBC). 
 
Funding: 
This project is supported by the Canadian Cardiovascular Society-
Bayer Resident Vascular Research Award and the UBC Division of 
Cardiology. 
 
 
Invitation and background 
You are being invited to consider participating in this research study because you had a 
myocardial infarction (heart attack) and being discharged home. Patients that suffer a heart attack 
are at higher risk for developing a cardiac arrhythmia (irregular heart beats) after leaving hospital. 
An area of the heart damaged during a heart attack may create abnormal electric currents making 
heart work very fast or slow. These arrhythmias can lead to palpitations (feeling of heart racing), 
fainting, and some could be life threating. Because of the arrhythmias, patients in the hospital 
wear cardiac monitors and are observed for at least 2 days.  
 
Although all patients will receive cardiac monitoring during their hospital stay, cardiac monitoring 
is currently not available once patients are discharged home. Without monitoring at home, 
patients may develop an arrhythmia that is not detected or unrecorded. Since the arrhythmia may 
only happen from time-to-time, they may not be detected by periodic monitoring or appointments 
with the family doctor or cardiologist. 
 
Atrial fibrillation (irregular beats from the upper chamber of the heart) is the most common type of 
arrhythmia after a heart attack. Atrial fibrillation can lead to a sensation of palpitations, and over 
the long term, can also increase the risk of suffering a stroke. Individuals that develop atrial 
fibrillation may benefit from the initiation of a blood thinner (anticoagulant) to reduce the risk of 
stroke. 
 
In this research study, individuals will be randomly assigned to receive an additional 30-day 
continuous monitor or standard medical care. Half of participants will be randomly assigned to 
use the 30-day continuous monitor to detect for cardiac arrhythmias once you have been 
discharged from hospital. The monitoring results will be shared with your primary cardiologist and 
family physician, and you will also have access to the information after collection is completed. 
The information will tell us more about what happens to your heart rhythm after going home, and 
whether you have any cardiac arrhythmias, including atrial fibrillation. We are planning enroll 264 
subjects at Vancouver General hospital. 
 
Your participation is voluntary 
It is a basic requirement of clinical research that a person who participates in the study of a new 
medical condition or treatment gives his or her informed consent to such participation. This 

SIMPL-AF Study 
Version 1.8, September 19, 2017 
Page 17 of 22 
consent must be based on an understanding of the procedures and risks involved. Please take 
your time in making your decision. If you decide to participate you will be asked to sign the last 
page of this form. You may choose not to participate, or you may withdraw from participation in 
the study at any time after you are enrolled without providing any reason. In either case, your 
standard medical care will not be affected by this decision 
 
Who is conducting the study 
This study is conducted by Dr. Jason Andrade and a group of cardiologists under the University 
of British Columbia (UBC). This project is supported by the Canadian Cardiovascular Society-
Bayer Resident Vascular Research Award and the UBC Division of Cardiology. 
 
Who can participate in this study 
Your medical history will be reviewed to determine that you meet all the criteria to participate in 
this study. The study doctor or staff will discuss them with you. You can participate if you: 
 
Are 18 years or older; 
 
Had a heart attack during this hospital admission; 
 
Have no history of atrial fibrillation in the past; 
 
Are not taking anticoagulants (type of blood thinner medication) for another reason 
 
You should not participate if you: 
 
Have chronic skin disorder on your upper torso; 
 
Are allergic to medical tape or glue; 
 
Received cardiac surgery (bypass surgery) during this hospitalization or have planned 
cardiac surgery within next 3 months; 
 
Had an atypical heart attack or disorder (called “spontaneous coronary artery dissection”, 
“non-atherosclerotic coronary disease” or “Takotsubo cardiomyopathy”); 
 
Are unable to take anticoagulation (type of blood thinner medication) for any reason 
 
What does the study involve? 
If you agree to participate in the study we will ask you sign this consent form before you leave the 
hospital. You will be randomized (like flipping a coin) and assigned to be in one of two groups: 
the standard of care group (without extra monitoring) or monitored group.   
 
Subjects in the monitored group prior to leaving hospital will be trained how to apply and use the 
SpiderFlash 30-day monitoring device. SpiderFlash is small medical device with three electrodes 
(wires) attached to your skin with special stickers. We ask that you disconnect the device and 
wires during showering, bathing, and swimming. You will be provided with extra stickers to 
reconnect the device, if any leads fall off. This device will begin recording your heart electrical 
activity (ECG or electrocardiogram) immediately and will continue for the next 30-days. 
 
If you are randomly assigned to receive the SpiderFlash device, you will receive training on 
wearing the device for the first time. This training will take between 30-60 minutes and will occur 
during your hospital stay. At home, routine changing of the leads is anticipated to take 5-10 
minutes per day. 
 
After 30 days we will see you in our research clinic for a follow-up visit and ask you to return the 
device. Your monitoring device will be analyzed and reviewed by the study investigators, and all 
results will be forwarded to your primary cardiologist and family physician. You will be asked about 
your current symptoms and any new health issues or hospital visits. We will also collect names 
of you current cardiac medications. This visit will take approximately 40 minutes of your time. 
 
At 3 months and 1 year after your discharge your will be contacted on the phone to review your 
current symptoms, new health problems and review your cardiac medications. This phone 
interview will take 15 minutes. At this time, your health records will also be reviewed for 
prescription information, electrocardiograms, new health issues, and hospital visits. You will have 

SIMPL-AF Study 
Version 1.8, September 19, 2017 
Page 18 of 22 
to dedicate about a total of 2 hours beyond that required for standard treatment (not including 
travel time) to complete the study. 
 
What if the monitor detects an arrhythmia? 
If you are randomly assigned to receive the 30-day monitor, the monitoring results will be 
forwarded to your primary cardiologist and family physician. If atrial fibrillation is detected, your 
primary cardiologist and family physician will have this information and treat you accordingly. 
Although patients with atrial fibrillation may benefit from taking a blood thinner (anticoagulant) to 
prevent stroke, this should only be started if it is consider safe in your circumstance. Thus, these 
medications will not be started as part of the research protocol- the final decision will be made by 
your primary cardiologist or family physician. If the 30-day monitor detects any other arrhythmias, 
your primary cardiologist and family physician will also have this information and treat you 
accordingly. 
 
What are the possible harms and discomforts?  
Potential risks associated with participation in this study are discomfort, redness or irritation under 
the electrodes when using the SpiderFlash device. We will simply ask you to disconnect the 
device if it causes you significant skin discomfort.   
 
What are the potential benefits of participating? 
You may not have any direct benefits from this study. You may experience better care from 
specialists, however, this is not guaranteed. You may be contributing to the medical knowledge 
about your heart condition. Information regarding any important changes discovered with your 
monitoring device will be forwarded to your doctors. 
 
What if new information becomes available that may affect my decision to participate? 
You will also be advised of any new information that becomes available that may affect your 
willingness to remain in this study. 
 
What are the alternatives to participating? 
If you chose not to participate in the study and develop symptoms of irregular heart-beat your 
doctor might give you a similar type of a monitoring device called Holter monitor. There will be no 
disadvantages should you decide not to participate in this study. 
 
What happens if I decide to withdraw my consent to participate? 
Participation in this study is voluntary. If you decide not to participate, this will not affect your 
medical care. You may discontinue participation in the study at any time without penalty or loss 
of benefits to which you are otherwise entitled. The Investigator will retain any data collected up 
to the point of a subject’s withdrawal from the study such that the data itself cannot be withdrawn. 
In no way does signing this form waive your legal rights, nor relieve the investigator or involved 
institutions from their legal and professional responsibilities. 
 
How will my taking part in this study be kept confidential? 
Your confidentiality will be respected. However, research records and health or other source 
records identifying you will be inspected in the presence of the Investigator, or his or her 
designate, by representatives of the UBC Clinical Research Ethics Board for the purpose of 
monitoring the research. By signing this form you are authorizing such access to your medical 
records. No information or records that disclose your identity will be published without your 
consent, nor will any information or records that disclose your identity be removed or released 
without your consent unless required by law.  
 
You will be assigned a unique study number as a participant in this study. This number will not 
include any personal information that could identify you (e.g., it will not include your Personal 
Health Number, SIN, or your initials, etc.). Only this number will be used on any research-related 
information collected about you during the course of this study, so that your identity will be kept 
confidential. Information that contains your identity will remain only with the Principal Investigator 

SIMPL-AF Study 
Version 1.8, September 19, 2017 
Page 19 of 22 
and/or designate. The list that matches your name to the unique study number that is used on 
your research-related information will not be removed or released without your consent unless 
required by law. 
  
Your rights to privacy are legally protected by federal and provincial laws that require safeguards 
to insure that your privacy is respected. You also have the legal right of access to the information 
about you that has been provided to the sponsor and, if needed, an opportunity to correct any 
errors in this information. Further details about these laws are available on request to your study 
doctor 
 
What happens if something goes wrong? 
Since no experimental treatment will be used in this research study, we do not anticipate any side 
effects as a result of participating in this study. By signing this form, you do not give up any of 
your legal rights and you do not release the study doctor, participating institutions, or anyone else 
from their legal and professional duties. If you become ill or physically injured as a result of 
participation in this study, medical treatment will be provided at no additional cost to you. The 
costs of your medical treatment will be paid by your provincial medical plan. 
 
What will the study cost me? 
All research-related tests that you will receive during your participation in this study will be 
provided at no cost to you. You will not be paid for your participation in the study.  
 
Who do I contact if I have questions about the study during my participation? 
If you have any questions or desire further information about this study before or during 
participation, you can contact Dr. Jason Andrade at (604) 875-5069. 
 
Who do I contact if I have any questions or concerns about my rights as a participant? 
If you have any concerns or complaints about your rights as a research participant and/or your 
experiences while participating in this study, contact the Research Participant Complaint Line in 
the University of British Columbia Office of Research Ethics by e-mail at RSIL@ors.ubc.ca or by 
phone at 604-822-8598 (Toll Free: 1-877-822-8598). 
 
After the study is finished 
The study results will be compiled and reported in a medical journal. A description of this clinical 
trial will be available on http://www.ClinicalTrials.gov. This Web site will not include information 
that can identify you. At most, the Web site will include a summary of the results. You can search 
this Web site at any time. 
 
 

SIMPL-AF Study 
Version 1.8, September 19, 2017 
Page 20 of 22 
 
Does Intensive Monitoring Improve Diagnosis and Treatment of Atrial Fibrillation after Myocardial 
Infarction (SIMPL-AF)  Participant Consent   
 
My signature on this consent form means: 
 
I have read and understood the information in this consent form.  
 
I have had enough time to think about the information provided. 
 
I have been able to ask for advice if needed. 
 
I have been able to ask questions and have had satisfactory responses to my questions.  
 
I understand that all of the information collected will be kept confidential and that the 
results will only be used for scientific purposes. 
 
I understand that my participation in this study is voluntary. 
 
I understand that I am completely free at any time to refuse to participate or to withdraw 
from this study at any time, and that this will not change the quality of care that I receive. 
 
I authorize access to my health records as described in this consent form.  
 
I understand that I am not waiving any of my legal rights as a result of signing this consent 
 
I understand that there is no guarantee that this study will provide any benefits to me.  
 
I consent to participate in this study 
 
________________________ 
_______________________   
_________________ 
Name of Participant:  
 
 
Signature: 
 
 
 
Date  
 
I have explained the purpose of this research, the study procedures, identifying those that are 
investigational, the possible risks and discomforts, as well as the potential benefits and have 
answered any questions regarding the study. The subject meets all inclusion and exclusion 
criteria for the study and freely agrees to participate. 
 
_______________________  
___________       ____________ 
_________________ 
Person Obtaining Consent:                   Signature          Study role                       Date  
 
 
____________________ 
 
_______________________  
_________________ 
Principal Investigator or  
 
 
  Signature: 
 
 
 
Date 
designated representative 
 
Was the participant assisted during the consent process in one of ways listed below?  Yes  
No 
 The consent form was read to the participant, and the person signing below attests that the 
study was accurately explained to, and apparently understood by, the participant.  
 The person signing below acted as an interpreter/translator for the participant, during the 
consent process (please check if an interpreter/translator assisted during the consent process). 
 If this consent process has been done in a language other than that on this written form, with 
the assistance of an interpreter/translator, indicate language: ____________________ 
 
 
______________________  
_______________________  
_________________ 
Signature of Person Assisting 
 
Signature: 
 
 
 
Date 
in the Consent Discussion

SIMPL-AF Study 
Version 1.8, September 19, 2017 
Page 21 of 22 
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Occluded Coronary Arteries. Journal of the American College of Cardiology. 1997;30:406-413. 
2. 
Pedersen OD, Bagger H, Kober L, Torp-Pedersen C. The occurrence and prognostic significance of atrial 
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Evalution. European heart journal. 1999;20:748-754. 
3. 
Lehto M, Snapinn S, Dickstein K, Swedberg K, Nieminen MS, investigators O. Prognostic risk of atrial 
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Siu CW, Jim MH, Ho HH, et al. Transient atrial fibrillation complicating acute inferior myocardial 
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