Evaluation of a New Cardiac Biomarker Assay

Abbott

Status and phase: Completed; Phase 3

Conditions: Acute Coronary Syndrome; Acute Myocardial Infarction

Treatments: Device: ARCHITECT STAT High Sensitive Troponin I Assay

Study type: Interventional

Funder types: Industry

Identifiers

NCT01608100

7B5-02-10A01-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1,101 participants in 1 patient group

ARCHITECT STAT High Sensitive Troponin I Assay testing

Experimental group

Description:

All subjects will have their blood tested by the investigational ARCHITECT STAT High SensitiveTroponin I assay.

Treatment:

Device: ARCHITECT STAT High Sensitive Troponin I Assay