The BEACON Registry: Best Expert Agreement for Care of Oc... | NCT00560248

Studies
The BEACON Registry: Best Expert Agreement for Care of Occult Myocardial Infarction (MI) Nationally

NCT00560248

Sponsor

The Cleveland Clinic

Status

Terminated

Last Update Posted

Feb 22, 2010Estimated

Enrollment

1,897Actual

Phase

Not provided

Conditions

Chest Pain

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CCF2007-001

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Loss of funding

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Sep 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Nov 16, 2007

First Submission Date that Met QC Criteria

Nov 16, 2007

First Posted Date

Nov 19, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2010

Last Update Posted Date

Feb 22, 2010Estimated

Name	Class
Heartscape Technologies, Inc.	INDUSTRY
Novella Clinical	OTHER
PharmaVigilant	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this registry is to assess and improve the process of care and health outcomes of patients presenting to the Emergency Department with chest pain suspected to be of cardiac origin. The study will identify which methods facilitate the diagnosis and risk stratification of ST elevation myocardial infarction (STEMI) or non STEMI, including patients with occult myocardial infarction (MI), and result in a shorter time to definitive diagnosis and treatment.

Detailed Description

The BEACON Registry is a multi-center data collection and follow-up registry. Participating Sites will collect information on patients presenting to the Emergency Department (ED) with chest pain. The purpose of the BEACON Registry is to evaluate the impact of new technologies, practice patterns and initiatives on patient time to diagnosis, patient time to treatment, patient survival and overall economics.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,897Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
I		Patients presenting to the Emergency Department with chest pain suspected to be of cardiac origin.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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		Index hospitalization

Secondary Outcomes

Measure	Description	Time Frame
Time to treatment, economic outcomes and survival outcomes		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients presenting with chest pain suspected to be of cardiac origin.

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients presenting to the Emergency Department with chest pain.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William F. Peacock, MD	The Cleveland Clinic	Principal Investigator
Deepak L. Bhatt, MD	VA Boston Healthcare System	Principal Investigator
Venugopal Menon, MD	The Cleveland Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cleveland Clinic		Cleveland	Ohio	44195	United States

Condition Browse Module

MeSH Terms

ID	Term
D002637	Chest Pain
D000072657	ST Elevation Myocardial Infarction
D004630	Emergencies

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided