i-STAT hs-TnI: Abbott i-STAT High Sensitivity Troponin I Study

Sponsor

Abbott Point of Care (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05629572

Collaborator

(none)

2,800

Enrollment

Locations

18.9

Anticipated Duration (Months)

700

Patients Per Site

37.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction	Diagnostic Test: i-STAT hs-TnI Cartridge Testing on i-STAT 1 and i-STAT Alinity

Study Design

Study Type:

Observational

Anticipated Enrollment :

2800 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Clinical Evaluation of the i-STAT High Sensitivity Troponin I Test to Aid in the Diagnosis of Myocardial Infarction (MI)

Actual Study Start Date :

Nov 4, 2022

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Adjudicated MI Prospectively collected whole blood specimens from subjects presenting to the ED with chest discomfort or equivalent ischemic symptoms suggestive of 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.	Diagnostic Test: i-STAT hs-TnI Cartridge Testing on i-STAT 1 and i-STAT Alinity Paired whole blood and plasma samples collected at multiple time points

Arm

Intervention/Treatment

Adjudicated MI

Prospectively collected whole blood specimens from subjects presenting to the ED with chest discomfort or equivalent ischemic symptoms suggestive of 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.

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

Paired whole blood and plasma samples collected at multiple time points

Outcome Measures

Primary Outcome Measures

Clinical sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) [9 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject is 18 years of age or older
Presenting to the ED with signs and symptoms suggestive of 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 an MI (in accordance with the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines)
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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mercy Gilbert	Chandler	Arizona	United States	85224
2	Hennepin Healthcare	Minneapolis	Minnesota	United States	55404
3	University of New Mexico	Albuquerque	New Mexico	United States	87131
4	Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

Abbott Point of Care

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abbott Point of Care

ClinicalTrials.gov Identifier:

NCT05629572

Other Study ID Numbers:

CS-2020-0012

First Posted:

Nov 29, 2022

Last Update Posted:

Dec 22, 2022

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Myocardial Infarction

Infarction

Study Results

No Results Posted as of Dec 22, 2022