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1 hs- c Tn  –   O ptimizing the 1 hs- c Tn  –   O ptimizing the

1 hs- c Tn – O ptimizing the - PowerPoint Presentation

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1 hs- c Tn – O ptimizing the - PPT Presentation

D iagnosis of Acut e M yocardial I nfarctionInjury in Women CODEMI a multicentre steppedwedge clusterrandomized controlled trial Dr Karin Humphries and Dr Jim Christenson ID: 790624

hospital ctn specific cut ctn hospital cut specific point lab cardiac provincial data cardiology women hospitaldr code lead outcomes

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Slide1

1

hs-

cTn – Optimizing the Diagnosis of Acute Myocardial Infarction/Injury in Women (CODE-MI): a multi-centre stepped-wedge cluster-randomized controlled trial

Dr. Karin Humphries and Dr. Jim Christenson

on behalf of CODE-MI Investigators

National Clinical Trial Identified Number:

NCT03819894

Slide2

2

Overall Objective

To evaluate the impact of using the female-specific 99th percentile cut-point for high-sensitivity cardiac troponin (hs-cTn), compared to the overall 99th percentile cut-point, on the diagnosis, treatment and outcomes of women presenting to the emergency department with cardiac chest pain.

Slide3

3

Rationale for CODE-MI

Compared to men, women with acute coronary syndrome (ACS) are:

More likely

to have:

Higher risk of short- and long-term mortality, particularly among younger women

L

ess

likely

to be:

Diagnosed with myocardial infarction (MI) due to atypical symptoms and equivocal ECG findings

Referred to a cardiologist

or

to coronary angiography or revascularization

Prescribed evidence-based cardiac medications

Slide4

4

Rationale for Code-MI

“Significantly lower values are observed among women…..sex-specific 99th percentile URLs are recommended for hs-cTn assays.”*Failure to account for lower 99th percentile cut-point in women may contribute to the under-diagnosis of MI and poorer outcomes observed in women compared to men*Thygesen et al. Fourth Universal Definition of Myocardial Infarction. JACC Vol 72 (18), 2018URL= upper reference limit

Slide5

5

4

th

Universal Definition of MI

Biomarkers

ECG

Symptoms

“the term myocardial infarction should be used when there is an acute myocardial injury with clinical evidence of acute myocardial ischemia and with detection of a rise and/or fall of cardiac troponin values with at least one value above

the 99

th

percentile upper reference limit

of a healthy population”

Slide6

Distribution of hs-cTn I in a healthy reference cohort

Mckie et al. Clinical Chemistry Vol 59 (7), 2013

648Female-specific cut-point < cut-point window of interest < overall cut-point

Slide7

7

Sex-specific

hs-cTn cut-points

Recommended sex-specific cut-points for

hs-cTn

I and T currently approved in Canada:

*Based on the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)

** Siemens

Attellica

99

th

Percentile*

Roche

hs-cTn T

Abbott

hs-cTn

I

Beckman hs-cTn I

Siemens

hs-cTn

I**

Overall

14

26

17

46

Female-

specific

9

16

12

39

Male

- specific

16

34

20

54

Slide8

8

Outcomes by Cut-Point

0 60 120 180 240 300 360 Survival free from death or recurrent myocardial infarction in women with Suspected Acute Coronary Syndrome Women with no MIWomen reclassified with MI based on sex-specific hs-cTn Women with MI by single cut-pointShah et al. BMJ 2015;350

Slide9

Whether implementation of female-specific hs-cTn diagnostic thresholds improves outcomes through better targeting of treatments requires urgent attention

9Call to Action

Despite this evidence and guidelines recommending sex-specific cut-points, a single, overall

cTn

cut-point is used in most clinical settings  

Slide10

10

Specific Objectives:

Examine the impact of using a lower female-specific hs-cTn cut-point on:Diagnostic and therapeutic strategiesPrognosis: all-cause mortality, non-fatal MI, incident heart failure (HF) hospitalization and emergent/urgent coronary revascularization at 30 days and one yearCosts of diagnostic testing and treatment

Slide11

11

Design: Stepped-Wedge, Cluster-Randomized

Clusters (hospitals) cross over sequentially, in random order, from control to intervention phaseAt end of study all clusters in intervention phaseControl Phase: Standard of care, with the use of single, overall hs-cTn cut-point in both sexesIntervention Phase: Introduction of female hs-cTn cut-point

Slide12

Data linkage

Data compilation from all sites

Data transfer to CIHI, Storage and AnalysisStudy Design and Timeline12

Slide13

13

Novel Study Features

Hospital not patient consentEvaluation of a change in process to routine clinical practice.Patients do not undergo any research-specific procedures.No screening or patient enrolmentProcess change is applied to everyone during intervention phaseNo data collection or follow-upStudy cohort and study outcomes are obtained from routine administrative data collection

Slide14

30 Sites across Canada

Slide15

Ontario and Quebec

Slide16

16

Study Population

Inclusion:Adults presenting to the emergency department (ED) with cardiac chest pain, with at least one hs-cTn test resultBased on CEDIS* codes 003 (chest pain, cardiac)Exclusion:< 20 years of ageInvalid personal health numberNot resident in the same province ED visit for chest pain within 1 year before current visit*Canadian Emergency Department Information System (CEDIS)ED patients with CEDIS code 004 (chest pain, non-cardiac) will also be monitored.

Slide17

17

Primary Outcome

Efficacy: Composite of all-cause mortality, non-fatal MI, hospitalization for incident HF, or urgent/emergent coronary revascularization at 1-year post index ED presentation (1-year MACE). Safety:BARC Major or Life-threatening BleedingBARC =The Bleeding Academic Research Consortium

Slide18

18

Main Statistical Analysis

Comparing the 1-year MACE rates between the control and intervention phases among females with peak hs-cTn within the cutpoint windowModel: mixed effects logistic regression adjusted for site variation and any secular trend

Slide19

19

Sample Size Considerations

Power calculations based on following assumptions:20% 1-year MACE rate in control phaserecruitment of 116 females*per site per 6 monthstwo-sided likelihood ratio test at 0.05 α level 84% power to detect a 15% reduction in the odds of the composite endpoint during the intervention phase

Slide20

Data Linkage

20

study cohort

Linkage process varies by site

The process involves linking the following data sources:

ED (NACRS) and Lab data

Discharge Abstract Database (DAD)

Provincial Prescription Database

Physician Billing

Vital Statistics

Data from all sites will be

de-identified,

stored and accessed for analysis via CIHI’s Secure Research Environment

Slide21

21

hs-cTn

assay in use for at least 6 months prior to randomizationCardiology, ED and Lab leads review/approve study logistics and hospital agrees to participateEthics approval / research contract set up for paymentCompleted training using preferred modality (e.g YouTube, slide presentation, information sheets) 6-8 weeks prior to transitioning to intervention phaseIT department ready to make relevant changes to lab reporting systemSite Preparation Checklist

Slide22

Study Organization:

Slide23

23

CODE-MI ICVHEALTH Team

Karin Humphries

MBA, DSc, FAHA

Principal Investigator

khumphries@icvhealth.ubc.ca

Salima

Jutha

B.Sc

, CCRA

National Coordinator

CodeMI@icvhealth.ubc.ca

Yinshan

Zhao

PhD

Director of Biostatistics

yzhao@icvhealth.ubc.ca

Mona Izadnegahdar

PhD

Epidemiologist

mizadnegahdar@icvhealth.ubc.ca

@

CodeMICanada

Slide24

24

Acknowledgements

Slide25

25

Additional Slides

Slide26

Lab

Cardiology

EDSt. Paul’s HospitalDr. Andre MattmanDr. Chris FordyceDr. Frank ScheuermeyerRoyal Jubilee/Victoria Genera HospitalDr. Gordon HoagDr. Simon RobinsonDr. Ross Hooker

Royal Columbian/ Surrey Memorial HospitalPending

British Columbia

Provincial Lead:

Dr. Frank

Scheuermeyer

Slide27

Alberta

Provincial Lead:

Dr. Colleen Norris

Lab

Cardiology

ED

University of Alberta Hospital

Dr. Albert

Tsui

Dr. Michelle Graham

Dr. Bill

Sevcik

Royal Alexander Hospital

Dr. Josh

Raizman

Dr. Ben Tyrrell

Dr. Colin Peterson

Foothills Hospital

Dr. Hossein

Sadrzadeh

Dr. Bryan

Har

TBD

Slide28

Lab

Cardiology

EDRoyal University HospitalDr. Andrew LyonDr. Paul BasranDr.Bruce CloadRegina General Hospital Dr. Bahera

MaliDr. Andrea Lavoie

Dr. Glenda Kaban

/

Dr. Terry Ross

Saskatchewan

Provincial Lead:

Dr. Andrew Lyon

Slide29

Lab

Cardiology

EDSt. Boniface HospitalDr. Laurel ThorlaciusDr. Shelley Zieroth/ Dr. Kunal MinhasDr. Paul Ratana

Manitoba

Provincial Lead:

Dr. Shelley

Zieroth

Slide30

Lab

Cardiology

EDMount Sinai HospitalDr. Barry HoffmanDr. Susanne MakDr. Bjug BorgundvaagSunnybrook HospitalDr. Mark CheungDr. Harindra

Wijeysundera

Dr. Jacques Lee

Toronto General Hospital/Toronto Western Hospital

Dr.

Vathany

Kulasingam

Dr. Jay

Udell

Dr. Steven Friedman

St. Michael’s Hospital

Dr. Daniel

Beriault

Dr.

Akshay

Bagai

/

Dr. Beth Abramson

Dr. Melissa McGowan

Kingston General Hospital

Dr. Michael Chan

Dr.

Amer

Johri

Dr. Michael Fitzpatrick

Ontario

Provincial Lead:

Dr. Jay

Udell

Slide31

Lab

Cardiology

EDOttawa Hospital General SiteDr. Ron BoothDr. Michele TurekDr. Venkatesh Thiruganasambandamoorthy

Ottawa Hospital Civic Site

Dr. Christopher McCudden

Dr. Derek So

Dr.

Venkatesh

Thiruganasambandamoorthy

Hamilton General Hospital (Hamilton Health Sciences)

Dr. Peter

Kavsak

Dr. Eva

Lonn

Dr.

Andrew

Worster

Juravinski

Hospital

(Hamilton Health Sciences)

Dr. Peter

Kavsak

Dr. Eva

Lonn

Dr. Andrew

Worster

University Hospital

(London Health Sciences)

Dr.

Vipin

Bhayana

Dr. Neville

Suskin

Dr. Jonathan Dreyer

Victoria Hospital

(London Health Sciences)

Dr.

Vipin

Bhayana

Dr. Neville

Suskin

Dr. Jonathan Dreyer

Ontario - continued

Slide32

Lab

Cardiology

ED Montreal General (MUHC)Dr. David BlankDr. Richard HaichinDr. Greg Clark/ Dr. Jean Marc Troquet Royal Victoria Hospital (Glen Site)Dr. David BlankDr. Richard HaichinDr. Greg Clark/ Dr. Jean Marc

Troquet

Montreal Heart Institute

Dr. Joel Lavoie

Dr. Marc

Jolicoeur

Dr. Alain

Vadeboncoeur

/

Dr. Michele Lucey

Jewish General

Dr. Elizabeth

MacNamara

Dr. Annabel Chen-

Tournoux

Dr. Marc

Afilalo

/ Dr. Eli Segal

St. Mary Hospital

Dr. Julie St-Cyr

Dr. Mathieu Walker

Dr.

Suj

Sivaraman

Quebec

Provincial Lead:

Dr. Louise

Pilote

Slide33

Lab

Cardiology

ED Saint John Regional HospitalDr. Jennifer SheaDr. Sohrab LutchmedialDr. Michael Howlett/ Dr. Paul Atkinson

New Brunswick

Provincial Lead:

Dr.

Ansar

Hassan

Slide34

Lab

Cardiology

ED Queen Elizabeth II HospitalDr. Amy LouDr. Ata Quraishi/Dr. Sharon MulvaghDr. Sam Campbell

Nova Scotia

Provincial Lead:

Dr.

Jafna

Cox

Slide35

High-STEACS vs CODE-MI

The High-STEACS trial, published in September 2018, did not identify improved outcomes with sex-specific

hs-cTn

cut-points. However, there are important differences that support the need for CODE-MI:

Slide36

Secondary Outcomes

Components of the

1-year composite outcome with death, to account for competing risk:Non-fatal MI and all-cause mortalityUrgent/emergent coronary revascularization and all-cause mortalityHospitalization for any cardiovascular indications (e.g. any HF or revascularization) and all-cause mortalityComposite of all-cause mortality, non-fatal MI, hospitalization for incident HF, or urgent/emergent coronary revascularization at 30 days post ED presentation (30-day MACE)

Slide37

Secondary Outcomes

Proportion of patients who:

Fill at least one prescription for evidence-based cardiac medications (beta-blockers, ACE-I/ARB, statins, anti-platelets)Undergo diagnostic tests (nuclear medicine cardiac scan, exercise stress test, diagnostic cardiac catheterization/CT angiogram or echocardiogram) within 90 days of the ED visitLength of stay during the index admissionHealth care utilization and cost associated with:Relevant physician visits, diagnostic testing, ED visits, hospitalizations and length of stay, and cost of prescription dispensing

Slide38

Planned Sub-group Analyses

1-year MACE outcome in females with CEDIS = 003 and peak

hs-cTn within the cut-point window of interest by:age: < 60 vs ≥ 60 yearsAssay: cTnT vs IChronic renal diseaseDiabetesChronic heart failure

Slide39

Exploratory Analyses

Females with peak

hs-cTn outside the cut-point window of interestMale patientsPatients with CEDIS = 004STEMI Patients

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