Myocardial Infarctioni-STAT hs-TnINCT05629572

Abbott i-STAT High Sensitivity Troponin I Study

An observational study of Myocardial Infarction, run by Abbott Point of Care at 28 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Myocardial Infarction
What is being tested?: i-STAT hs-TnI Cartridge Testing on i-STAT 1 and i-STAT Alinity
How many people: 3,697 participants
Where: 28 sitesUnited States
Study dates: 2 Nov 2022to 11 Mar 2024
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: The population consisted of subjects presenting to emergency departments (ED) with chest discomfort or equivalent ischemic symptoms suggestive of acute coronary syndrome (ACS) and had an electrocardiogram (ECG) ordered as part of their standard of care (SOC).

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

28 sites in 1 country.

City, postcode or hospital

28 sites in 1 country

United States28 sites

University of New Mexico
Albuquerque, New Mexico, 87131
Cooper University Hospital
Camden, New Jersey, 08103
Mercy Gilbert Medical Center
Chandler, Arizona, 85224
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia
Charlottesville, Virginia, 22903
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
Ohio State University Medical Center
Columbus, Ohio, 43210
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-8579
Henry Ford Health System
Detroit, Michigan, 48202
Florence Medical Centre (MUSC Health)
Florence, South Carolina, 29505
Penn State University Hershey Medical Center
Hershey, Pennsylvania, 17033
Baylor College of Medicine
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
University of Kansas Medical Center
Kansas City, Kansas, 66160
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89012
Kentucky Clinical Trials Labatory
Louisville, Kentucky, 40202
Hennepin Healthcare (Research Institute/Minneapolis Medical Research Foundation)
Minneapolis, Minnesota, 55404
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Eastside Research Associates
Redmond, Washington, 98052
Mayo Clinic
Rochester, Minnesota, 55906
University of California at San Francisco
San Francisco, California, 94110
Washington University
St Louis, Missouri, 63110
Stanford Medical Center
Stanford, California, 94305
Stony Brook University
Stony Brook, New York, 11974-8167
Tampa General Hospital
Tampa, Florida, 33606
Baylor Scott and White Healthcare
Temple, Texas, 76508
Geroge Washington University
Washington D.C., District of Columbia, 20037
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27151

Other trials in United States

About this study

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

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.

Read the detailed 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.

Conditions: Myocardial Infarction
Being tested: i-STAT hs-TnI Cartridge Testing on i-STAT 1 and i-STAT Alinity
Medical subject headings: Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

i-STAT hs-TnI Cartridge Testing on i-STAT 1 and i-STAT AlinityDiagnostic test
Paired whole blood and plasma samples collected at multiple time points.

Study groups in NCT05629572
Study group	Role	What they receive
Prospective subjects in Emergency Department (ED) with symptoms of acute coronary syndrome (ACS).		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. Receives: Diagnostic Test: i-STAT hs-TnI Cartridge Testing on i-STAT 1 and i-STAT Alinity

What is being measured

The primary outcome is the main question the study is designed to answer.

Performance of i-STAT hs-TnI cartridge
Performance metrics calculated using adjudicated outcomes with the hs-TnI test results.
Measured: Up to 9 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Nov 202211 Mar 2024

First posted29 Nov 2022
Study start2 Nov 2022
Primary completion6 Feb 2024
Study completion11 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 3,697 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05629572
Sponsor's protocol ID: CS-2020-0012
Acronym: i-STAT hs-TnI
Status last verified: Sep 2024
First submitted: 11 Nov 2022
Last updated: 19 Sep 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Bertrand ME, Simoons ML, Fox KA, Wallentin LC, Hamm CW, McFadden E, de Feyter PJ, Specchia G, Ruzyllo W. Management of acute coronary syndromes: acute coronary syndromes without persistent ST segment elevation; recommendations of the Task Force of the European Society of Cardiology. Eur Heart J. 2000 Sep;21(17):1406-32. doi: 10.1053/euhj.2000.2301. No abstract available.
PubMed 10952834
Braunwald E, Antman EM, Beasley JW, Califf RM, Cheitlin MD, Hochman JS, Jones RH, Kereiakes D, Kupersmith J, Levin TN, Pepine CJ, Schaeffer JW, Smith EE 3rd, Steward DE, Theroux P, Alpert JS, Eagle KA, Faxon DP, Fuster V, Gardner TJ, Gregoratos G, Russell RO, Smith SC Jr. ACC/AHA guidelines for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients With Unstable Angina). J Am Coll Cardiol. 2000 Sep;36(3):970-1062. doi: 10.1016/s0735-1097(00)00889-5. No abstract available.
PubMed 10987629
Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). J Am Coll Cardiol. 2018 Oct 30;72(18):2231-2264. doi: 10.1016/j.jacc.2018.08.1038. Epub 2018 Aug 25. No abstract available.
PubMed 30153967
Sharma S, Jackson PG, Makan J. Cardiac troponins. J Clin Pathol. 2004 Oct;57(10):1025-6. doi: 10.1136/jcp.2003.015420. No abstract available.
PubMed 15452153
Alushi B, Jost-Brinkmann F, Kastrati A, Cassese S, Fusaro M, Stangl K, Landmesser U, Thiele H, Lauten A. High-Sensitivity Cardiac Troponin T in Patients with Severe Chronic Kidney Disease and Suspected Acute Coronary Syndrome. J Clin Med. 2021 Sep 17;10(18):4216. doi: 10.3390/jcm10184216.
PubMed 34575325
Wu AHB, Mahler SA, House SL, Jortani SA, Creer MH, Rising KL, Bischof JJ, Crystal C, Headden GF, Apple FS, Harrison NE, Meltzer AC, Baca JT, Tiffany B, Sochor M, Pentecostes GU, Di Tullio KP, Gupta MS, Singer AJ, Januzzi JL. Clinical Performance of a Novel Point-of-Care High-Sensitivity Cardiac Troponin I Assay. J Appl Lab Med. 2026 Jan 5;11(1):98-112. doi: 10.1093/jalm/jfaf152.
PubMed 41146629

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationPhase 3
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
RecruitingObservational study
Breisgau PHENO-HEART MI
Myocardial Infarction, STEMI
Recruiting
CRP Apheresis in Infarct-Related Cardiogenic Shock
Cardiogenic Shock, Acute Myocardial Infarction (AMI)
Recruiting
Reducing Slow/No-Reflow With Prophylactic High-Dose Intracoronary Adenosine Protocol in ST-Elevation Myocardial Infarction The REFLOW AMI Trial
ST-Elevation Myocardial Infarction (STEMI)
Not yet recruitingPhase 2
Evaluating SGLT2 Inhibitors for the Reduction of No-Reflow Phenomenon in Patients Undergoing PCI
No Reflow Phenomenon, Reperfusion Injuries, Myocardial

All Myocardial Infarction trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of the i-STAT High Sensitivity Troponin I Test to Aid in the Diagnosis of Myocardial Infarction (MI)
ClinicalTrials.gov ID: NCT05629572
Acronym / sponsor ID: i-STAT hs-TnI / CS-2020-0012
Conditions: Myocardial Infarction
Study type: Observational
Recruitment status: Completed
Enrolment: 3,697 participants (actual)
Lead sponsor: Abbott Point of CareIndustry (pharma, biotech, devices)
Study start: 2 Nov 2022 (actual)
Primary completion: 6 Feb 2024 (actual)
Study completion: 11 Mar 2024 (actual)
First posted: 29 Nov 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Prospective subjects in Emergency Department (ED) with symptoms of acute coronary syndrome (ACS).	–	Diagnostic Test: i-STAT hs-TnI Cartridge Testing on i-STAT 1 and i-STAT AlinityProspectively 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The population consisted of subjects presenting to emergency departments (ED) with chest discomfort or equivalent ischemic symptoms suggestive of acute coronary syndrome (ACS) and had an electrocardiogram (ECG) ordered as part of their standard of care (SOC).

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
i-STAT hs-TnI Cartridge Testing on i-STAT 1 and i-STAT AlinityPaired whole blood and plasma samples collected at multiple time points.	Diagnostic test	Prospective subjects in Emergency Department (ED) with symptoms of acute coronary syndrome (ACS).

Primary outcome

Performance of i-STAT hs-TnI cartridge
Time frame: Up to 9 hours
Performance metrics calculated using adjudicated outcomes with the hs-TnI test results.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Background: PubMed 10952834Bertrand ME, Simoons ML, Fox KA, Wallentin LC, Hamm CW, McFadden E, de Feyter PJ, Specchia G, Ruzyllo W. Management of acute coronary syndromes: acute coronary syndromes without persistent ST segment elevation; recommendations of the Task Force of the European Society of Cardiology. Eur Heart J. 2000 Sep;21(17):1406-32. doi: 10.1053/euhj.2000.2301. No abstract available.
Background: PubMed 10987629Braunwald E, Antman EM, Beasley JW, Califf RM, Cheitlin MD, Hochman JS, Jones RH, Kereiakes D, Kupersmith J, Levin TN, Pepine CJ, Schaeffer JW, Smith EE 3rd, Steward DE, Theroux P, Alpert JS, Eagle KA, Faxon DP, Fuster V, Gardner TJ, Gregoratos G, Russell RO, Smith SC Jr. ACC/AHA guidelines for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients With Unstable Angina). J Am Coll Cardiol. 2000 Sep;36(3):970-1062. doi: 10.1016/s0735-1097(00)00889-5. No abstract available.
Background: PubMed 30153967Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). J Am Coll Cardiol. 2018 Oct 30;72(18):2231-2264. doi: 10.1016/j.jacc.2018.08.1038. Epub 2018 Aug 25. No abstract available.
Background: PubMed 15452153Sharma S, Jackson PG, Makan J. Cardiac troponins. J Clin Pathol. 2004 Oct;57(10):1025-6. doi: 10.1136/jcp.2003.015420. No abstract available.
Background: PubMed 34575325Alushi B, Jost-Brinkmann F, Kastrati A, Cassese S, Fusaro M, Stangl K, Landmesser U, Thiele H, Lauten A. High-Sensitivity Cardiac Troponin T in Patients with Severe Chronic Kidney Disease and Suspected Acute Coronary Syndrome. J Clin Med. 2021 Sep 17;10(18):4216. doi: 10.3390/jcm10184216.
Derived from this study: PubMed 41146629Wu AHB, Mahler SA, House SL, Jortani SA, Creer MH, Rising KL, Bischof JJ, Crystal C, Headden GF, Apple FS, Harrison NE, Meltzer AC, Baca JT, Tiffany B, Sochor M, Pentecostes GU, Di Tullio KP, Gupta MS, Singer AJ, Januzzi JL. Clinical Performance of a Novel Point-of-Care High-Sensitivity Cardiac Troponin I Assay. J Appl Lab Med. 2026 Jan 5;11(1):98-112. doi: 10.1093/jalm/jfaf152.

Related trials for Myocardial Infarction

Enrolling by invitationPhase 3
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
RecruitingObservational study
Breisgau PHENO-HEART MI
Myocardial Infarction, STEMI
Recruiting
CRP Apheresis in Infarct-Related Cardiogenic Shock
Cardiogenic Shock, Acute Myocardial Infarction (AMI)
Recruiting
Reducing Slow/No-Reflow With Prophylactic High-Dose Intracoronary Adenosine Protocol in ST-Elevation Myocardial Infarction The REFLOW AMI Trial
ST-Elevation Myocardial Infarction (STEMI)
Not yet recruitingPhase 2
Evaluating SGLT2 Inhibitors for the Reduction of No-Reflow Phenomenon in Patients Undergoing PCI
No Reflow Phenomenon, Reperfusion Injuries, Myocardial

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Manish Gupta, MS, MBA study director

Abbott Point of Care

28 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Myocardial Infarction, run by Abbott Point of Care at 28 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performance of i-STAT hs-TnI cartridge (time frame: Up to 9 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05629572, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 28 Oct 2026.