Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1000 participants
OBSERVATIONAL
2020-10-13
2024-10-13
Brief Summary
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The Siemens POC High Sensitivity Troponin-I Test System is to be used as an aid in the diagnosis of myocardial infarction (MI).
Detailed Description
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* Evaluate the clinical performance of the Siemens POC HS cTn-I test system for the diagnosis and rule out of AMI in patients presenting to the emergency department in whom serial cTnI measurements are obtained on clinical indication.
* Correlate the blood and plasma outcomes on the Siemens POC HS cTn-I test system as function of the corresponding hematocrit (Hct) values.
Hypothesis: The Siemens POC HS cTn-I Test System will offer an excellent diagnostic performance for acute myocardial injury and acute myocardial infarction, as well as expedite the risk stratification of patients for early discharge from the emergency department.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort
Study population: Prospective, observational cohort study of consecutives patients (goal, 1000 patients over 4 months) presenting to the emergency department, in whom serial cTnI measurements are ordered on clinical indication at Hennepin Healthcare / Hennepin County Medical Center (Minneapolis, MN, USA) to rule-in and rule-out acute myocardial infarction.
Cardiac Troponin Testing
Lithium heparin whole blood and plasma samples will be measured with Siemens POC High Sensitivity Troponin-I Test System.
Interventions
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Cardiac Troponin Testing
Lithium heparin whole blood and plasma samples will be measured with Siemens POC High Sensitivity Troponin-I Test System.
Eligibility Criteria
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Inclusion Criteria
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
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.
21 Years
ALL
No
Sponsors
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Hennepin Healthcare Research Institute
OTHER
Siemens Healthineers
UNKNOWN
Responsible Party
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Principal Investigators
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Fred S Apple, PhD
Role: PRINCIPAL_INVESTIGATOR
Hennepin Healthcare Research Institute
Locations
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Hennepin Healthcare Research Institute / Hennepin County Medical Center
Minneapolis, Minnesota, United States
Countries
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References
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Neumann JT, Twerenbold R, Ojeda F, Aldous SJ, Allen BR, Apple FS, Babel H, Christenson RH, Cullen L, Di Carluccio E, Doudesis D, Ekelund U, Giannitsis E, Greenslade J, Inoue K, Jernberg T, Kavsak P, Keller T, Lee KK, Lindahl B, Lorenz T, Mahler SA, Mills NL, Mokhtari A, Parsonage W, Pickering JW, Pemberton CJ, Reich C, Richards AM, Sandoval Y, Than MP, Toprak B, Troughton RW, Worster A, Zeller T, Ziegler A, Blankenberg S; ARTEMIS study group. Personalized diagnosis in suspected myocardial infarction. Clin Res Cardiol. 2023 Sep;112(9):1288-1301. doi: 10.1007/s00392-023-02206-3. Epub 2023 May 2.
Apple FS, Smith SW, Greenslade JH, Sandoval Y, Parsonage W, Ranasinghe I, Gaikwad N, Schulz K, Stephensen L, Schmidt CW, Okeson B, Cullen L; SAMIE Investigators. Single High-Sensitivity Point-of-Care Whole-Blood Cardiac Troponin I Measurement to Rule Out Acute Myocardial Infarction at Low Risk. Circulation. 2022 Dec 20;146(25):1918-1929. doi: 10.1161/CIRCULATIONAHA.122.061148. Epub 2022 Oct 31.
Other Identifiers
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SEIGE
Identifier Type: -
Identifier Source: org_study_id