Download Off-Pump CABG Meta-Analysis / Stroke

The BEACON Registry
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
BEACON – Executive Committee
• W. Frank Peacock, MD (Chairman), Cleveland Clinic
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Deepak L. Bhatt, MD, Cleveland Clinic
Christopher P. Cannon, MD, Brigham & Women’s Hospital
James Hoekstra, MD, Wake Forest University
Arthur Hiller (Non-voting) CEO, Heartscape Technologies, Inc.
BEACON – Steering Committee
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W. Frank Peacock, MD (Chairman), Cleveland Clinic
Deepak L. Bhatt, MD, Cleveland Clinic
Christopher P. Cannon, MD, Brigham & Women’s 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
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
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
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%)
The Chest Pain Pie
Musculoskeletal Pain
IVDA Pulm Infarction
Breast Abcess
Blunt Chest Trauma
Anxiety
Pneumothorax
Mediastinitis
Pulmonary Embolus
Empyema
Panic Attack
Pneumonia
Breast Implant
Aortic Dissection
Mondor’s
Syndrome
Tietze’s
disease
GERD
Thoracic
Spine Ds
Asthma
Herpes
Zoster
Contact
Dermatitis
Breast
Cancer
MalloryWeiss
Subdiaphrag
Abcess
Lung
Cancer
Sickle cell
Anemia
Amniotic Fluid
Embolus
Myocardial Pain
Boerhave’s
Of all the Chest Pain coming to the ER, what do we
know…..
NRMI 2%
CRUSADE 16%
82%
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 2000;342:1163-70
12 lead ECG errors
• 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
• False Negatives
– Prior Q waves
– Error
– Ventricular aneurysm
– Paced rhythm
– LBBB
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
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
BEACON
Secondary Objectives
• 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
-METHYL-P-[123I]IODOPHENYLPENTADECANOIC
ACID (IODOFILTIC ACID I 123
Coronary CTA
PROCESS
POC, 24/7 rest mibi
D2B
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
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.
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.
BEACON – Study Design
• 30 Clinical Sites
• Each site will enroll at least 60 STEMI and high risk patients in
Part 1a and 1b (n=1800) 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 (n=68,200)
• Total of 70,000 patients in the Registry
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
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 >1mm 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
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
BEACON – Electronic Data Collection (EDC)
• InSpire System, password protected
• Access via BEACON Web Site: www.beaconregistry.com
• 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 – patient’s medical record
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
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
BEACON – EDC Demographics
BEACON – EDC Arrival/Discharge
BEACON – Electronic Data Collection
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Signs & symptoms
Vital Signs
Cardiopulmonary Exam
Medical History
ED Laboratory Assessments (whatever is available)
– Troponin
Hct
– CK-MB
INR
– BNP
Lipids
– Creatinine
HgbA1c
BEACON – EDC Signs & Symptoms
BEACON – EDC Cardiopulmonary Exam
BEACON – EDC Medical History
BEACON – EDC Laboratory Tests
BEACON – Electronic Data Collections
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12-Lead ECG
Augmented 15-18 Lead ECG
Right side ECG
PRIME ECG®
• Concurrent Medications
BEACON – ECG data
• 12-Lead ECG
– Data from routine report
• PRIME ECG®
– Data from routine report
BEACON – EDC ECG
BEACON – EDC ECG cont.
BEACON – EDC PRIME ECG ®
BEACON – EDC PRIME ECG ® cont.
BEACON – EDC Concurrent Medications
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
BEACON – Electronic Data Collection
• Emergency Department Discharge Diagnosis
– Date & Time
• Observation Unit Discharge Diagnosis
• Final Hospital Discharge Diagnosis
BEACON – EDC ED Disposition Decision
BEACON – EDC ED Discharge Diagnosis
BEACON – Electronic Data Collection
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Echocardiogram
SPECT
Coronary CT
Cardiac Catheterization
• Mortality Status – 1 year from ED presentation
BEACON – EDC Imaging
BEACON – EDC Coronary CT
BEACON – EDC Cardiac Catheterization
BEACON – EDC Mortality Status
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.
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
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)
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
BEACON – Web Page
• www.beaconregistry.com
– Access EDC
– Protocol Training
– Contacts
– Chat Room
– Links
– Resources
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
BEACON
• Please sign the Certificate of Training and
– Keep for your files
– Fax copy to Karen Mrazeck @ 216 444 9732
– Protocol Questions?
– Call Sue Jasper @ 216 445 3484 or email: [email protected]
Thank you
Flor Azul
Honduras
[email protected]