Abbott i-STAT High Sensitivity Troponin I Study (i-STAT hs-TnI)

Abbott

Status

Completed

Conditions

Myocardial Infarction

Treatments

Diagnostic Test: i-STAT hs-TnI Cartridge Testing on i-STAT 1 and i-STAT Alinity

Study type

Observational

Funder types

Industry

Identifiers

NCT05629572

CS-2020-0012

Details and patient eligibility

About

The goal of this observational multi-center study is to evaluate the clinical performance of the i-STAT hs-TnI test (i-STAT High Sensitivity Troponin I) using the investigational i-STAT hs-TnI cartridge for the proposed intended use as an aid in the diagnosis and treatment of myocardial infarction (MI). The cartridge measures cardiac troponin I (cTnI) in whole blood or plasma samples using the i-STAT 1 Analyzer or i-STAT Alinity Instrument. Subjects presenting to the emergency department (ED) with chest discomfort or equivalent ischemic symptoms suggestive of Acute Coronary Syndrome (ACS) who are enrolled in this study will be asked to provide blood samples for testing.

Full description

The i-STAT High Sensitivity Troponin I (i-STAT hs-TnI) test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I (cTnI) in whole blood or plasma samples using the i-STAT 1 Analyzer or i-STAT Alinity Instrument in point of care or clinical laboratory settings. The hs-TnI test is intended to be used as an aid in the diagnosis of myocardial infarction (MI).

The objective of this study is to evaluate the clinical performance of the i-STAT hs-TnI test using the investigational i-STAT hs-TnI Cartridge with the i-STAT 1 Analyzer and i-STAT Alinity Instrument for subjects presenting to the emergency department (ED) with chest discomfort or equivalent ischemic symptoms suggestive of acute coronary syndrome (ACS).

The clinical evaluation will use prospectively collected whole blood specimens from subjects presenting to the ED with chest discomfort or equivalent ischemic symptoms suggestive of ACS.

Enrollment

3,697 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject is 18 years of age or older
Presenting to the Emergency Department (ED) with signs and symptoms suggestive of Acute Coronary Syndrome (ACS): Acute chest, epigastric, neck, jaw or arm pain or discomfort or pressure without apparent non-cardiac source; Shortness of breath, nausea, vomiting, fatigue/malaise; Other equivalent discomfort suggestive of a myocardial infarction (MI) in accordance with the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines.
Electrocardiogram (ECG) ordered as part of the standard of care

Exclusion criteria

Previously enrolled in the study
Enrolled in any interventional clinical trial (within the last 30 days)

Trial design

3,697 participants in 1 patient group

Prospective subjects in Emergency Department (ED) with symptoms of acute coronary syndrome (ACS).

Description:

Prospectively collected whole blood specimens from subjects presenting to the emergency department (ED) with chest discomfort or equivalent ischemic symptoms suggestive of acute coronary syndrome (ACS). For this study's MI adjudication, a minimum of 2 samples are to be tested on the site's standard of care (SOC) instrument, one at baseline and one at another time point (T1, T2, T3). For each of the SOC test results, a corresponding research draw for testing on the i-STAT hs-TnI cartridge should be attempted, if feasible. For research, a minimum of 2 samples are to be tested on i-STAT instruments, one at baseline and one at an additional timepoint. Enrollment will be monitored throughout the clinical study.

Treatment:

Diagnostic Test: i-STAT hs-TnI Cartridge Testing on i-STAT 1 and i-STAT Alinity