NCT00206817

Brief Summary

This clinical trial is being conducted to 1) evaluate the possible usefulness of a panel of cardiac markers in assessing emergency department patients with possible acute coronary syndrome, 2) evaluate the usefulness of BNP in assessing emergency department patients with possible acute coronary syndrome, 3) determine if BNP can be used to predict adverse events during hospitalization and in the emergency department, and 4) evaluate how a Point-of-Care testing platform affects resource utilization in the emergency department.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

6 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

July 21, 2015

Status Verified

July 1, 2015

First QC Date

September 13, 2005

Last Update Submit

July 20, 2015

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity of the three-marker versus the four-marker panelDetermine the added benefit of BNP in the diagnosis of patients with ACS

Secondary Outcomes (1)

  • Determine the economic and resource utilization benefit of the POC platform vs. standard lab testing

Interventions

Triage CardioProfilER (Troponin I, Myoglobin, CK-MB, BNP)DEVICE

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than or equal to 21 years at the time of enrollment Chest discomfort or other symptoms consistent with possible ACS as indicated by the treating physician obtaining an ECG and cardiac markers for the patient's evaluation New onset or worsening symptoms within six hours of presentation to the ED.

You may not qualify if:

  • History of CHF per patient history or in the available medical record. History of end stage renal disease on dialysis. Refused informed consent.4) Refused medical record review and telephone follow up at 30 days and six months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Henry Ford Health Systems

Detroit, Michigan, 48202, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Wake Forest Univ. Baptist Med. Center

Winston-Salem, North Carolina, 27157, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267-0769, United States

Location

Cleveland Clinic Foundation Dept. of Emergency Medicine

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Andra L Blomkalns, MD

    University of Cinncinati

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

October 1, 2003

Last Updated

July 21, 2015

Record last verified: 2015-07

Locations

US(6)