EICHORCondition: Acute Myocardial Infarction · Acute Coronary Syndrome · Sponsor: Fred Apple
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The Mindray High Sensitivity Troponin-I Measurement System is an in vitro diagnostic test for the quantitative determination of high sensitivity cardiac troponin I (hs-cTnI) in human serum or plasma. The Mindray High Sensitivity Troponin-I Measurement System is to be used as an aid in the diagnosis and rule out of acute myocardial infarction (AMI).
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Inclusion Criteria: 1. Presents to the ED, or ambulatory care center equivalent, with signs or symptoms suspicious of a possible ACS/ischemic event. 2. Baseline cTn-I measurement and one additional cTn-I measurement at two hours after the first measurement. 3. At least one 12-lead electrocardiogram Exclusion Criteria: 1. Less than 21 years old 2. Pregnancy 3. Trauma 4. Declines to participate or has indicated that their blood/ medical information cannot be used for investigational purposes 5. Did not present through the ED 6. Transferred from an outside hospital or clinic 7. Has already been enrolled in the study
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Hennepin Healthcare Research Institute / Hennepin County Medical Center | Minneapolis, Minnesota, United States | — |
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Source record: clinicaltrials.gov/study/NCT05853042