Clinical trial NCT01608100: Evaluation of a New Cardiac Biomarker Assay
Official title: Design Validation Protocol for the Evaluation of ARCHITECT STAT High Sensitive Troponin I Assay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Coronary Syndrome
Acute Myocardial Infarction
Lead sponsor: Abbott Diagnostics Division
Sponsor class: INDUSTRY
First posted: 2012-05-30
Enrollment: 1101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of the study is to evaluate the performance and intended use of a new cardiac biomarker test, Troponin I, in an intended use population. Blood specimens will be tested using the new investigational test that detects the level of Troponin I. Results will be compared to the diagnosis of whether or not an acute myocardial infarction (MI) occurred.

Detailed description: The purpose of the cardiac biomarker Troponin I is to aid in the diagnosis of myocardial infarction.The assay is also intended to assist in the prognosis relative risk to all cause mortality (ACM) and major adverse cardiac events (MACE) consisting of myocardial infarction, revascularization, and cardiac death in patients who present with symptoms suggestive of acute coronary syndrome (ACS) without a diagnosis of myocardial infarction.

All specimens were collected under a separate specimen collection protocol (Protocol No, 7B5-02-09A01-01: Clinical Specimen Procurement for Biomarker Evaluation of Suspected ACS). The specimens that will be tested include approximately 8300 specimens collected from 1101 subjects presenting to Emergency Departments with signs and symptoms of Acute Coronary Syndrome and will be provided to the clinical sites performing investigational Troponin I testing.

Eligibility criteria: Inclusion Criteria:

* presenting to the Emergency Department with symptoms consistent with or suggestive of Acute Coronary Syndrome (ACS) defined as at least 5 minutes of chest pain (or symptoms consistent with myocardial ischemia) up to 6 hours prior to initial evaluation.
* an Electrocardiogram (ECG) result within 2 hours of presentation for observation of Acute Coronary Syndrome (ACS).
* greater than 18 years of age.
* not known to be pregnant.
* agreement to the follow-up required by the study.

Exclusion Criteria:

* prior participation in this study.
* require dialysis for end stage renal disease.
* history of a previous heart transplant.
* coexisting disorder associated with limited life expectancy.
* currently participating in another investigational device or drug study.

Primary outcomes:
measure: Clinical Performance - Area Under the Curve
timeFrame: Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department
measure: Clinical Performance- Sensitivity
timeFrame: Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department
measure: Clinical Performance- Specificity
timeFrame: Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department.
measure: Clinical Performance- Negative Predictive Value (NPV)
timeFrame: Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department.
measure: Clinical Performance- Positive Predictive Value (PPV)
timeFrame: Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department.
Secondary outcomes:
measure: Prognosis
timeFrame: 30-day and 90-day follow-up
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Chandler Regional Medical Center
state: Arizona
city: Palo Alto
country: United States
facility: Stanford University School of Emergency Medicine
state: California
city: Fort Lauderdale
country: United States
facility: Nationwide Laboratory Services
state: Florida
city: Port Jefferson
country: United States
facility: John T Mather Memorial Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Hershey
country: United States
facility: Pennsylvania State University- Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Austin
country: United States
facility: Hospital Physicians in Clinical Research
state: Texas
city: Bryan
country: United States
facility: Hospital Physicians in Clinical Research
state: Texas
city: Charlottesville
country: United States
facility: Dept of Emergency Medicine University of Virginia
state: Virginia
city: Bellingham
country: United States
facility: St Joseph Hospital
state: Washington
Study officials:
affiliation: Hennepin Healthcare Research Institute
name: Fred S Apple, PhD
role: PRINCIPAL_INVESTIGATOR
name: Frank Peacock, MD
role: STUDY_CHAIR
References: