Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05853042
Other study ID # MERITnI
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 12, 2022
Est. completion date May 15, 2024

Study information

Verified date March 2024
Source Hennepin Healthcare Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Description:

Study purpose/objective: - 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 Healthcare/Hennepin 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1500
Est. completion date May 15, 2024
Est. primary completion date March 15, 2024
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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

Study Design


Intervention

Diagnostic Test:
high-sensitivity cardiac troponin testing
Lithium heparin plasma samples will be measured with Mindray Bio-Medical CL-1200i Chemiluminescence Immunoassay Analyzer.

Locations

Country Name City State
United States Hennepin Healthcare Research Institute / Hennepin County Medical Center Minneapolis Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Hennepin Healthcare Research Institute Mindray Bio-Medical Electronics Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Examine the incidence of undetectable(<LoD), measurable (LoD - 99th percentile), and increased (>99th percentile) cTn concentrations for the Mindray Bio-Medical hs-cTnI assay using the CL-1200i analyzer. Examine the incidence of undetectable( Day 1
Primary Examine Concordance Examine analytical and clinical concordance and discordance predicated on sex-specific 99th percentiles between Mindray hs-cTnI concentrations in comparison to the Abbott Alinity high sensitivity cTnI assay. Day 1
Primary Examine the diagnostic performance for acute myocardial injury and acute myocardial infarction. Examine the diagnostic performance for a) acute myocardial injury and b) acute myocardial infarction based on various diagnostic strategies using hs-cTnI measurement(s), as follows:
Single measurement rule out strategy
Limit of detection (LoD)
Derive an optimal rule-out (ng/L) hs-cTnI cutoff for the Mindray Bio-Medical hs-cTnI assay using the CL-1200i analyzer to meet an early rule out clinical need
Accelerated serial sampling (0/2h protocol) rule out strategy
a) Delta (absolute concentration serial change value, 0-2h) analysis
Diagnosis performance predicated on sex-specific 99th percentile URLs
Day 1
Primary Describe the incidence of MI and myocardial injury, clinical characteristics and 30-day safety outcomes risk of patients with and without hs-cTnI increases above the sex-specific 99th percentile URLs Describe the incidence of MI and myocardial injury, clinical characteristics and 30-day safety outcomes risk of patients with and without hs-cTnI increases above the sex-specific 99th percentile URLs, including patients categorized with acute myocardial injury and acute myocardial infarction, including type 1 and 2 myocardial infarction, following the 4th Universal Definition of Myocardial Infarction. Day 1
Primary Impact on the incidence of myocardial injury and myocardial infarction diagnoses. Examine the potential impact on the incidence of myocardial injury and myocardial infarction diagnoses using hs-cTnI upon clinical practice implementation with a comparison to the hospital's final ICD-10 code diagnosis of type 1 and type 2 MIs, and non-MI myocardial injury. Day 1
Secondary All-cause mortality All cause death up to 30 days
Secondary Cardiac mortality Death due to cardiac pathophysiology up to 30 days
Secondary Adjudicated index acute myocardial infarction according to Fourth Universal Definition of Myocardial Infarction. Acute myocardial infarction including all sub-types following the Fourth Universal Definition of Myocardial Infarction guidelines. on admission
Secondary Safety Outcomes Determine major adverse cardiovascular events, including cardiac death, myocardial infarction, unplanned revascularization and all-cause death. 30 days
See also
  Status Clinical Trial Phase
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Recruiting NCT06013813 - Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI N/A
Recruiting NCT05412927 - AngelMed Guardian® System PMA Post Approval Study
Completed NCT02750579 - Early or Delayed Revascularization for Intermediate and High-risk Non ST-elevation Acute Coronary Syndromes? N/A
Completed NCT04102410 - Assessing Force-velocity Profile: an Innovative Approach to Optimize Cardiac Rehabilitation in Coronary Patients N/A
Enrolling by invitation NCT03342131 - Serum Concentration of Wnt2 and Wnt4 in Patients With Acute Coronary Syndrome N/A
Recruiting NCT01218776 - International Survey of Acute Coronary Syndromes in Transitional Countries
Enrolling by invitation NCT04676100 - International CR Registry
Completed NCT03590535 - 5th Generation cTnT in ED ACS
Recruiting NCT05437900 - INSIGHTFUL-FFR Clinical Trial Phase 4
Completed NCT05551429 - Factors Related to Participation in Cardiac Rehabilitation in Patients With Acute Coronary Syndrome
Terminated NCT04316481 - IDE-ALERTS Continued Access Study N/A
Active, not recruiting NCT04475380 - Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
Not yet recruiting NCT04852146 - Electronic Feedback for Data Restitution and Valorization to the Emergency Teams in Aquitaine.
Active, not recruiting NCT02892903 - In the Management of Coronary Artery Disease, Does Routine Pressure Wire Assessment at the Time of Coronary Angiography Affect Management Strategy, Hospital Costs and Outcomes? N/A
Completed NCT02944123 - Half Dose of Prasugrel and Ticagrelor in Acute Coronary Syndrome (HOPE-TAILOR) Phase 3
Not yet recruiting NCT02871622 - BMX Alpha Registry: a Post-market Registry of the BioMatrix Alpha TM N/A
Completed NCT04077229 - Piloting Text Messages to Promote Positive Affect and Physical Activity N/A
Active, not recruiting NCT02922140 - The Impact of Pharmaceutical Care Practice on Patients in Cardiac Rehabilitation Unit N/A
Terminated NCT02620202 - Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain