The BEACON Registry

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The BEACON Registry
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BEACON

• Principal Investigators
• W. Frank Peacock, MD, FACEP
• Deepak L. Bhatt, MD, FACC
• Sponsor
• Heartscape Technologies, Inc.
• Clinical Trial Management
• C5Research
• Data/database Web Site Management
• PharmalinkFHI

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BEACON Executive Committee

• W. Frank Peacock, MD (Chairman), Cleveland Clinic
• Deepak L. Bhatt, MD, Cleveland Clinic
• Christopher P. Cannon, MD, Brigham Womens
  Hospital
• James Hoekstra, MD, Wake Forest University
• Arthur Hiller (Non-voting) CEO, Heartscape
  Technologies, Inc.

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BEACON Steering Committee

• W. Frank Peacock, MD (Chairman), Cleveland Clinic
• Deepak L. Bhatt, MD, Cleveland Clinic
• Christopher P. Cannon, MD, Brigham Womens
  Hospital
• James Hoekstra, MD, Wake Forest University
• Arthur Hiller, CEO, Heartscape Technologies, Inc.
• Deborah B. Diercks, MD, UC Davis Health System
• Cindy L. Grines, MD, William Beaumont Hospital
• Charles V. Pollack, Jr., MD, Pennsylvania
  Hospital
• Robert L. Jesse, MD, Virginia Commonwealth
  University
• E. Magnus Ohman, MD, Duke University Medical
  Center

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BEACON C5Research

• Susan Jasper, RN, Project Manager
• Marilyn Borgman, RN, Project Manager
• Karen Mrazeck, Project Specialist
• Danielle Brennan, MS, Senior Statistician
• Alex Fu, PhD, Assistant Professor

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BEACON - Rationale

• 2 of patients seen for chest pain are quickly
  identified as STEMI from a standard 12-lead ECG
• Remaining 98 of patients undergo a battery of
  tests
• Of these, 10-15 will eventually be diagnosed as
  acute coronary syndrome (ACS) and admitted to the
  hospital
• The remainder will be sent home after several
  hours in the ED

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ED Visits - US
130,000,000 annually
10.4 M chest pain (8.0)
6.24 M suspected or actual cardiac
4.1 M sent home non-cardiac
50,000 MIs
3.1 M non-cardiac (50)
1.2 M AMI (20)
1.5 M UA (24)
374,400 sudden death (6)
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The Chest Pain Pie
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Myocardial Pain
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Of all the Chest Pain coming to the ER, what do
we know..
NRMI 2
CRUSADE 16
82
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Pre-test odds defined N 10,869 8 MI rate 17
ACS rate
Pope JH, et al. Missed Diagnosis of Acute Cardiac
Ischemia in the Emergency Department. N Engl J
Med 20003421163-70
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12 lead ECG errors

• False Negatives
• Prior Q waves
• Error
• Ventricular aneurysm
• Paced rhythm
• LBBB

• False Positives
• BER
• LBBB
• LV aneurysm
• Pre-excitation
• Brugada syndrome
• Peri/myocarditis
• Pulmonary embolism
• J wave of Osborne
• Mimics
• Subarachnoid hemorrhage
• Cholecystitis
• Pancreatitis
• Metabolic disturbances (e.g. ?K)
• Error
• Failure to recognize nl J point limits
• Lead transposition

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BEACON Rationale

• The use of additional testing on patients may
  improve
• Hospital performance and efficiency measures,
  and
• Provide earlier identification of the patients
  who would ultimately be admitted for ACS
• This Registry will provide an opportunity to
  demonstrate which diagnostic methods facilitate
  earlier treatment of patients

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BEACON Primary Objective

• The primary objective is to
• assess and ultimately improve the process of care
  and health outcomes of patients presenting with
  chest pain suspected to be of cardiac origin
• This will include identifying which methods
  facilitate the diagnosis and risk stratification
  of STEMI or non-STEMI patients, including
  patients with occult myocardial infarction (MI)
  and result in a shorter time to definitive
  diagnosis and treatment

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BEACON Secondary Objectives
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(IODOFILTIC ACID I 123

• The secondary objective is to determine the
  impact of
• new technologies
• practice patterns
• initiatives on
• patient time to diagnosis
• patient time to treatment
• patient survival and overall economics

Coronary CTA
PROCESS POC, 24/7 rest mibi D2B
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BEACON Secondary Objectives

• Including
• Testing/evaluation with cardiac imaging versus
  standard 12-lead ECG alone versus enhanced lead
  ECG, including 80-lead PRIME ECG
• STEMI outcomes diagnosed by various technologies
• Impact of various marker strategies
• Point of care testing vs. lab based strategies
• High sensitivity vs. standard assay platforms

HsTn IMA MPO ST-2 Scube 1 MMX
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BEACON Study Design

• Multi-center Data Collection Follow-up Registry
• Participating centers will complete a survey
  regarding their current cardiac marker
  strategies, lab platforms, accessibility to
  nuclear and other innovative diagnostic
  technology.
• Participating centers will have enhanced lead ECG
  (PRIME ECG) technology available. A work
  station, training and 30 vests will be provided
  to each Site at no cost by Heartscape
  Technologies. Usage of the PRIME ECG is not
  required, but when it is used its impact as a new
  modality will be assessed.
• All data collected will be standard of care at
  each institution.

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BEACON Study Design

• Electronic Data Collection (EDC) technology will
  be used to assign unique patient identifiers and
  collect data on patients.
• Sites will receive quarterly reports indicating
  their
• enrollment
• outcomes
• key quality indicators
• rates of compliance with AHA/ACC 1A
  recommendations for the care of ACS patients.

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BEACON Study Design

• 30 Clinical Sites
• Each site will enroll at least 60 STEMI and high
  risk patients in Part 1a and 1b (n1800) and
• Each site will enroll approximately 64 patients
  per month (all patients presenting with chest
  pain suspected to be of cardiac origin) in Part 2
  (n68,200)
• Total of 70,000 patients in the Registry

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BEACON Study Design

• Part 1a 30 patients without PRIME ECG
  available
• Part 1b patients with PRIME ECG available
  sites will collect data on this group of patients
  until they have used PRIME ECG on 30 patients.
  This group will include patients with 12-lead
  identified STEMI
• Part 2 All patients presenting with chest pain
  suspected to be of cardiac origin with PRIME ECG
  available

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BEACON Inclusion Criteria

• 1) Positive Troponin defined by institutional
  standard
• OR
• 2) At least 10 minutes of chest pain within 24
  hours of presentation AND any one of the
  following
• a) ST elevation gt1mm on 12 lead ECG, in any 2
  anatomically contiguous leads
• b) New LBBB
• c) ST depression of at least 0.5mm on 12 lead
  ECG, in any 2 anatomically contiguous leads
• d) Age 55

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BEACON Inclusion Criteria cont.

• e) History of PTCA, PCI, CABG, MI or myocardial
  ischemia by stress test
• f) Receiving treatment for diabetes or
  hyperlipidemia
• g) More than 20 pack years of cigarette
  smoking
• h) Admits to cocaine usage ever
• THERE ARE NO EXCLUSION CRITERIA

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BEACON Electronic Data Collection (EDC)

• InSpire System, password protected
• Access via BEACON Web Site www.beaconregistry.co
  m
• Data collected via chart review
• List of ICD chest pain codes
• Print out from PRIME ECG
• All information from current ED visit
• 30 day follow up if any information available
• 1 year mortality status via Social Security Death
  Index date of inquiry to be 18 months after ED
  presentation to allow for 6 month delay in SSDI
  system
• Source document patients medical record

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BEACON EDC HIPKey

• HIPKey a random, secure 32 digit patient
  identifier
• Patient information used is not saved in any
  form, it is consumed
• HIPKey generated from
• Last name
• First name
• Gender
• Date of Birth
• Last 4 digits of SSN
• Country

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BEACON Electronic Data Collection

• Patient demographics
• Emergency Department arrival date time
• Hospital discharge date
• Number of hospital days
• ICU or Telemetry
• Non-ICU Telemetry
• Day defined as where patient is at midnight

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BEACON EDC Demographics
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BEACON EDC Arrival/Discharge
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BEACON Electronic Data Collection

• Signs symptoms
• Vital Signs
• Cardiopulmonary Exam
• Medical History
• ED Laboratory Assessments (whatever is available)
• Troponin Hct
• CK-MB INR
• BNP Lipids
• Creatinine HgbA1c

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BEACON EDC Signs Symptoms
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BEACON EDC Cardiopulmonary Exam
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BEACON EDC Medical History
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BEACON EDC Laboratory Tests
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BEACON Electronic Data Collections

• 12-Lead ECG
• Augmented 15-18 Lead ECG
• Right side ECG
• PRIME ECG
• Concurrent Medications

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BEACON ECG data

• 12-Lead ECG
• Data from routine report
• PRIME ECG
• Data from routine report

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BEACON EDC ECG
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BEACON EDC ECG cont.
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BEACON EDC PRIME ECG
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BEACON EDC PRIME ECG cont.
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BEACON EDC Concurrent Medications
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BEACON Electronic Data Collection

• Emergency Department Disposition Decision
• Date Time
• Location
• Definition of Disposition Time
• the time that the decision is made about what to
  do with the patient
• the time physician writes order for cardiac cath
  OR when the cardiac cath lab is called OR
• The time physician writes order for admission OR
  when admitting office is called OR
• the time the patient is discharged from the ED

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BEACON Electronic Data Collection

• Emergency Department Discharge Diagnosis
• Date Time
• Observation Unit Discharge Diagnosis
• Final Hospital Discharge Diagnosis

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BEACON EDC ED Disposition Decision
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BEACON EDC ED Discharge Diagnosis
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BEACON Electronic Data Collection

• Echocardiogram
• SPECT
• Coronary CT
• Cardiac Catheterization
• Mortality Status 1 year from ED presentation

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BEACON EDC Imaging
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BEACON EDC Coronary CT
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BEACON EDC Cardiac Catheterization
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BEACON EDC Mortality Status
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BEACON Primary Endpoint

• Time to definitive diagnosis of
• STEMI
• UA/NSTEMI
• Non-cardiac chest pain
• Time to disposition decision will be used as an
  objective measure of time to definitive
  diagnosis.

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BEACON Primary Endpoint

• Time to disposition decision
• STEMI - the time of ED admission to the time
  physician writes order for cardiac cath OR when
  the cardiac cath lab is called
• UA/NSTEMI the time of ED admission to the time
  the physician writes order for admission or when
  admitting office is called
• Non-cardiac chest pain the time of ED admission
  to the time the patient is discharged from the ED

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BEACON Secondary Endpoints

• Quality indicators (time to treatment)
• Economic outcomes (LOS, cost of diagnosis, cost
  of treatment)
• Survival outcomes (during hospitalization, 30
  day, 1 year)

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BEACON Statistical Analysis

• Endpoints will be described by
• Type of diagnosis (STEMI, UA/NSTEMI, and
  non-cardiac chest pain)
• Diagnostic device utilized and testing procedures
  performed within each group
• A cost will be assigned to each test, procedure
  and treatment so a total relative cost can be
  calculated for each type of diagnosis

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BEACON Web Page

• www.beaconregistry.com
• Access EDC
• Protocol Training
• Contacts
• Chat Room
• Links
• Resources

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BEACON Benchmark Reports

• Quarterly reports
• Each site will receive CD containing their data
• Enrollment
• Key BEACON variables
• Outcomes
• JCAHO Quality measurements
• Rates of compliance with AHA/ACC 1A
  recommendations for the care of ACS patients

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BEACON

• Please sign the Certificate of Training and
• Keep for your files
• Fax copy to Karen Mrazeck _at_ 216 444 9732
• Protocol Questions?
• Call Sue Jasper _at_ 216 445 3484 or email
  jaspers_at_ccf.org

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• Thank you

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Flor Azul Honduras
Frankpeacock_at_gmail.com