SpinChip Hs-cTnI Clinical Diagnostic Performance
NCT Number: NCT06499519
Acronym: HEAT-4
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Myocardial Infarction
Interventions: DIAGNOSTIC_TEST: SpinChip hs-cTnI
Sponsor: SpinChip Diagnostics ASA
Collaborators: Scandinavian Contract Research Organization
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-15
Completion Date: 2025-07-01
Locations: Akershus University hospital, Akershus Clinical Research Center (ACR), Lørenskog, Akerhus, 1474, Norway|Haukland University Hospital, Department of Heart Disease, Bergen, Vestland, 5021, Norway|University hospital Basel, Cardiovascular Research Institute of Basel (CRIB), Basel, 4056, Switzerland|Luzerner Kantonsspital, Luzern, 6000, Switzerland

Summary:
During a heart attack, the protein troponin I is released from the heart muscle into the bloodstream. Measurements of cardiac troponin in blood are used as an aid in the diagnosis of heart attack. The SpinChip hs-cTnI test is a new high-sensitive test for measuring the amount of cardiac troponin I in the bloodstream as an aid in the diagnosis of heart attack.

The purpose of this study is to evaluate the diagnostic accuracy and safety of the SpinChip hs-cTnI test relative to a clinically validated hs-cTnI method.

Primary Outcome Measures: Area under the receiver operating characteristics (AUROC) curve for cTnI concentrations measured at admission to the emergency department (ED), Calculate and compare the area under the curve (AUC) for both SpinChip hs-cTnI and clinically validated hs-cTnI method using centrally adjudicated diagnosis of AMI, Day of admission
Secondary Outcome Measures: AUROC for cTnI concentrations measured at 1, 2 and 3 hours after admission to the ED, Calculate and compare the area under the curve (AUC) for both SpinChip hs-cTnI and clinically validated hs-cTnI method using centrally adjudicated diagnosis of AMI for the given timepoints, Day of admission|Negative predictive value (NPV) at 0, 1, 2, and 3 hours after admission to the ED using the 99th percentile upper reference limit as clinical cut-off, NPV is defined as the proportion of subjects with measured cTnI concentrations below a clinical cut-off value, who are correctly diagnosed as not having MI.

The NPVs of the SpinChip hs-cTnI test will be calculated for 0, 1, 2, and 3 hours timepoints, using the overall and sex-specific 99th percentile upper reference limits as clinical cut-offs., Day of admission|Positive predictive value (PPV) at 0, 1, 2, and 3 hours after admission to the ED using the 99th percentile upper reference limit as clinical cut-off, PPV is defined as the proportion of subjects with measured cTnI concentrations above a clinical cut-off value, who are diagnosed with MI.

The PPV of the SpinChip hs-cTnI test will be calculated for cTnI concentrations obtained 0, 1, 2, and 3 hours timepoints, using the overall and sex-specific 99th percentile URL as clinical cut-offs., Day of admission|Occurrence of MI and/or cardiovascular death (CV) within 30 days, Prognostic accuracy for risk of MI/CV death for 30 days evaluated using Kaplan-Meier plots

Cox proportional hazard model will be used to evaluate the prognostic performance of the SpinChip hs-cTnI test for outcomes MI and CV death within 30 days., 30 days|Derivation and validation of rule-in/rule-out 0/1h and 0/2h algorithms, Rule-in/rule-out algorithms will be calculated in accordance with the European Society of Cardiology (ESC) rapid rule-in/rule-out protocols for cTnI results obtained at admission (0h) and 1 hours, as well as 0 h and 2 hours after admission. The rule-out limit will be derived so that the sensitivity and NPV is \> 99%, and rule-in limit so that the diagnostic specificity and PPV is \> 70% using 60% of the study population. The derived rule-out and rule-in limits will be validated using a remaining population., Day of admission|Incidence of AEs, ADEs and DDs, Assess the safety of the SpinChip Platform, as measured by adverse events (AEs), adverse device effects (ADEs) and device deficiencies (DDs)., Day of admission