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 • 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 • 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%)
Musculoskeletal Pain Blunt Chest Trauma Mediastinitis Panic Attack IVDA Pulm Infarction Anxiety Pulmonary Embolus Breast Abcess Pneumonia Pneumothorax Empyema Breast Implant Aortic Dissection Mondor’s Syndrome Tietze’s disease GERD Thoracic Spine Ds Asthma Herpes Zoster Contact Dermatitis Breast Cancer Mallory- Weiss Subdiaphrag Abcess Sickle cell Anemia Lung Cancer Amniotic Fluid Embolus Boerhave’s Myocardial Pain
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 – 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
BEACON – Electronic Data Collections • 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 – 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 – Electronic Data Collection • Echocardiogram • SPECT • Coronary CT • Cardiac Catheterization • Mortality Status – 1 year from ED presentation
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