Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05853042
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2023-05-01
Brief Title:
MERITnI - Mindray-hs-cTnI Assay Analytical and Clinical Evaluation for the Diagnosis and RIsk AssessmenT of Myocardial InfarctIon
Sponsor:
Hennepin Healthcare Research Institute
Organization:
Hennepin Healthcare Research Institute
Study Overview
Official Title:
MERITnI - Mindray-hs-cTnI Assay Analytical and Clinical Evaluation for the Diagnosis and RIsk AssessmenT of Myocardial InfarctIon
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MERITnI
Brief Summary:
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
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
Detailed Description:
Study purposeobjective
Determine the sex-specific 99th percentile upper reference limits URLs for the Mindray hs-cTnI assay using the CL-1200i Instrument
Method comparison across the dynamic range of cTnI concentrations between the Mindray hs-cTnI assay and the Abbott Alinity hs-TnI assay used in clinical practice at Hennepin HealthcareHennepin County Medical Center
Evaluate the clinical performance of the Mindray hs- cTnI measuring system for the diagnosis of myocardial infarction MI for early rule out MI and myocardial injury and assessment of 30-day safety outcomes in patients presenting to the emergency department ED in whom serial cTnI measurements 0h 2h 4h 6h are obtained on clinical indication at Hennepin Healthcare Hennepin County Medical Center Minneapolis MN USA to rule-in and rule-out MI
Determine the sex-specific 99th percentile upper reference limits URLs for the Mindray hs-cTnI assay using the CL-1200i Instrument
Method comparison across the dynamic range of cTnI concentrations between the Mindray hs-cTnI assay and the Abbott Alinity hs-TnI assay used in clinical practice at Hennepin HealthcareHennepin County Medical Center
Evaluate the clinical performance of the Mindray hs- cTnI measuring system for the diagnosis of myocardial infarction MI for early rule out MI and myocardial injury and assessment of 30-day safety outcomes in patients presenting to the emergency department ED in whom serial cTnI measurements 0h 2h 4h 6h are obtained on clinical indication at Hennepin Healthcare Hennepin County Medical Center Minneapolis MN USA to rule-in and rule-out MI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None