Abbott i-STAT High Sensitivity Troponin I Study (i-STAT hs-TnI)
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 21-008237
NCT ID: NCT05629572
About this study
The purpose 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).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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).
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 3/8/23. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Leslie Donato, Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available