Evaluation of Serial Troponin and Cardiac Multimarkers at the Point of Care in the Emergency Department

Acute Coronary Syndrome Clinical Trial

— ESTIMATE  

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00907231
• Other study ID #: BSTE-0112
• Status: Withdrawn
• Phase: N/A
• First received: May 20, 2009
• Last updated: July 20, 2015
• Start date: February 2010
• Est. completion date: May 2010

Study information

• Verified date: July 2015
• Source: Biosite
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This is a multi-center study to assess the diagnostic accuracy of the Troponin I assay in the Biosite Triage Cardio3 Panel at the point-of-care (POC) in adults presenting to the emergency department with possible acute myocardial infarction (AMI).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older at time of enrollment

• Presenting to the ED within 6 hours from onset of chest discomfort (pain, pressure, tightness, etc) consistent with a possible diagnosis of AMI or ACS and with an initial ECG non-diagnostic for injury (or injury equivalent resulting in emergent reperfusion therapy). (NOTE: Subjects who have chest discomfort that is episodic or stuttering in nature may be included if the ED presentation is within 6 hours of symptom onset.)

• Experiencing at least 30 minutes of chest pain or other anginal equivalent symptoms. (Note: Subjects who have symptoms of shorter duration due to pharmacologic intervention may be included.)

Exclusion Criteria:

• Patient (or Legal Representative) unable or unwilling to provide written informed consent.

• Patient unwilling or unlikely to comply with study procedures, including protocol-specified blood sampling or telephone follow-up at 30 days and 6 months.

• Vulnerable populations as deemed inappropriate for study by site principal investigator.

• ST-elevation or other ECG criteria that result that is diagnostic for AMI and results in patient being sent for percutaneous coronary interventions (PCI) or being treated with thrombolytics6.

• Pulmonary Edema requiring CPAP, BIPAP, or mechanical ventilation

• Tachyarrhythmias (SVT, V-Tach, rapid atrial fib)

• End Stage Renal Disease on Hemodialysis

• Cardiac Arrest prior to arrival

• Implantable Defibrillator firing prior to arrival

• Hemodynamically unstable patients

• Trauma injury to the chest

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Myocardial Infarction
• Chest Pain
• Myocardial Infarction

Locations

Country	Name	City	State
United States	Erlanger Medical Center	Chattanooga	Tennessee
United States	Mountain States Health Alliance	Johnson City	Tennessee
United States	Loyola University Medical Center	Maywood	Illinois
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Oregon Health and Sciences University	Portland	Oregon
United States	Stony Brook University Medical Center	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Biosite

Country where clinical trial is conducted

United States,