Title: The BEACON

(Best Expert Agreement for Care of Occult MI Nationally)
Registry
Version Date:
06 November-2007
Protocol Number:
2007-001

PRINCIPAL INVESTIGATORS:

W. Frank Peacock, MD, FACEP
Deepak L. Bhatt, MD, FACC
Venu Menon, MD, FACC

SPONSOR:

Heartscape Technologies, Inc.
9160 Rumsey Road, Suite B-8
Columbia, MD 21045

CLINICAL TRIAL MANAGEMENT:

Cleveland Clinic Cardiovascular Coordinating Center (C5)
Cleveland Clinic
9500 Euclid Ave.
Cleveland, OH
44195

PROTOCOL SUMMARY

Title

The BEACON (Best Expert Agreement for Care of Occult MI Nationally) Registry

Background

Prompt diagnosis and management of acute coronary syndromes remain a major healthcare challenge. The current standard of an initial 12-lead ECG and biomarker measurement still misses or delays treatment for a substantial proportion of patients who in fact have an acute coronary syndrome.

Rationale

2% of patients seen for chest pain are quickly identified as ST elevation myocardial infarction (STEMI) from a standard 12-lead ECG. The remaining 98% of patients undergo a battery of tests and possibly observation in the emergency room or hospital setting. Of these, 10-15% will eventually be diagnosed (usually by cardiac markers) as acute coronary syndrome (ACS) and admitted to the hospital. The remainder will be sent home after several hours in the ED. The use of additional testing on patients who are negative for STEMI on the 12-lead ECG may improve hospital performance and efficiency measures, and provide earlier identification for many of the patients who would ultimately be admitted for some kind of coronary syndrome. This Registry will provide an opportunity to demonstrate which diagnostic methods facilitate earlier treatment of patients. It may also demonstrate the clinical and economic value of earlier diagnosis in this cohort.

Objectives

The primary objective of this Registry 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.

The secondary objective is to determine the impact of new technologies, practice patterns, and initiatives on patient time to diagnosis, patient time to treatment, patient survival and overall economics. These will include, but are not limited to:

1) Testing/evaluation with cardiac imaging, e.g., thallium scans, CT scans, and other similar technology versus standard 12-lead ECG alone versus enhanced lead ECG, including 80-lead PRIME ECG®

2) STEMI outcomes diagnosed by various technologies

3) Impact of various marker strategies
a. Point of care testing vs. lab based strategies
b. High sensitivity vs. standard assay platforms

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, and quality improvement process strategies. Additionally, centers will have enhanced lead ECG (PRIME ECG®) technology available. Usage of the PRIME ECG® is not required, but when it is used its impact as a new modality will be assessed.

ACC/AHA 1A recommendations will be the practice guidelines encouraged at all sites.

Electronic Data Collection (EDC) technology will be used to assign unique patient identifiers and collect data on patients presenting in the Emergency Department with chest pain. Sites will receive quarterly reports indicating their enrollment, outcomes, key quality indicators (e.g. time to diagnosis) and rates of compliance with AHA/ACC 1A recommendations for the care of ACS patients.

To minimize potential patient selection bias, the Steering Committee will review data on the type of patients enrolled and outcomes by site. Any site whose data deviates significantly from the mean, or shows significant bias in patient selection will have additional contact and education to resolve the situation.

At least 30 sites will participate. It is anticipated that each site will enroll 60 STEMI and high risk patients in Part 1a and 1b (n=1800) and 64 patients per month (all patients presenting with chest pain suspected to be of cardiac origin) in Part 2 (n=68,200) for a total of approximately 70,000 patients in the Registry.

Endpoints

Primary Endpoint:
Time to definitive diagnosis of STEMI, UA/NSTEMI, and non-cardiac chest pain. Time to disposition decision will be used as an objective measure of time to definitive diagnosis.

Secondary Endpoints:
1. Quality indicators (time to treatment)
2. Economic outcomes (LOS, cost of diagnosis, cost of treatment)
3. Survival outcomes (during hospitalization, 30 day*, 1 year)

* 30 day outcomes will be collected and assessed from hospitals that have a process for routine 30-day follow-up of these patients that does not require patient to sign an informed consent (QA, routine contact or IRB waiver of informed consent).

Inclusion Criteria

Part 1a: Sites will collect data on 30 patients presenting to their ED with chest pain, who meet the inclusion criteria, without the availability of PRIME ECG® technology.
Part 1b: Sites will collect data on patients presenting to their ED with chest pain, who meet the inclusion criteria, with the availability of PRIME ECG® technology. Sites will collect information on this group of patients until they have used PRIME ECG® on 30 patients. These patients will include those with 12-lead identified STEMI and patients meeting the following criteria:

Inclusion Criteria (any 1 constitutes eligibility)

1) Positive troponin defined by institutional standard
2) At least 10 minutes of chest pain (or symptoms believed to represent a myocardial ischemic equivalent), within 24 hours of presentation, and any one of the following:
     a) ST elevation > 1 mm on 12 lead ECG, in any 2 anatomically contiguous leads
     b) New LBBB
c) ST depression of at least 0.5 mm on 12 lead ECG, in any 2 anatomically contiguous leads
d) Age ? 55
e) History of PTCA, PCI, CABG, MI, or myocardial ischemia diagnosed by stress testing
f) Receiving treatment for diabetes or hyperlipidemia
g) More than 20 pack years of cigarette smoking
h) Admits to cocaine usage ever

Part 2: Sites will collect information on patients presenting with chest pain suspected to be of cardiac origin or anginal equivalent, with the availability of PRIME ECG® technology.

Follow Up: 1 year after enrollment, sites will collect mortality status on all patients using the SSN Death Index.
Registry Duration: 4 years.

Exclusion Criteria

None.

Data Collection

Data collection will be done utilizing a web-based electronic data capture system. This will provide timely capture of data to produce quarterly reports on the quality indicators for each site. The system will create a unique identifier that will protect patient confidentiality yet allow patients to be tracked should they return to the site with repeat episodes of chest pain.
Sites will also be asked to provide patient mortality status at 1 year by using the SSN Death Index.

Statistical Analysis

Endpoints will be described by type of diagnosis (STEMI, UA/NSTEMI, and non-cardiac chest pain), and by 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.

Statistical comparisons of the impact of each test on continuous endpoints will be done using ANCOVA to adjust for covariates such as site factors. Transformations or non-parametric techniques will be considered if the endpoint is not normally distributed. Logistic regression or Cox proportional hazards regression will be used to compare binary and time-to-event outcomes, respectively.

Standard costs will be applied to each test and treatment for the economic analysis of cost of diagnosis and treatment.

Dr. Bhatt's BEACON Presentation at ACC

Slide Set

Review Deepak Bhatt's BEACON update presented at Heartscape Meeting at ACC.