Acute Myocardial Infarction
Conditions
Keywords
Acute Myocardial Infarction, High-sensitive, Point of Care, Troponin I, Near-patient test, Heart attack, Diagnostic accuracy
Brief 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.
Detailed description
Cardiac troponins are widely used as a biomarker to aid in the diagnosis of acute myocardial infarction (AMI). These structural proteins are essential in regulating contraction in cardiac muscle cells, and they are sensitive and specific biochemical markers of myocardial damage. During a heart attack, cardiac muscle cells are injured and release the cardiac marker troponin I (cTnI) into the bloodstream. High-sensitive troponin tests may detect the increase of cardiac troponin in blood within hours after the symptoms of a heart attack has started. The SpinChip high-sensitivity cardiac troponin I (hs-cTnI) test is a new high-sensitive test for measuring troponin I in blood samples, and the analysis may be performed close to the patient (near-patient test). The results may be obtained within 10 minutes, compared to approximately 1 hour for normal laboratory analysis. The SpinChip Platform consists of the SpinChip hs-cTnI test and the SpinChip Analyzer and may be used at the emergency department to evaluate patients presenting with symptoms of acute myocardial infarction (chest pain). The test can use blood from finger prick or venous blood samples, either as whole blood or separated into plasma This study is a multicentre, prospective, observational, non-randomised, open clinical performance study for evaluation of the diagnostic accuracy and safety of the SpinChip hs-cTnI test as an aid in the diagnosis of AMI. Subjects presenting with acute chest discomfort or other symptoms suggestive of AMI will be recruited at the emergency departments (EDs).
Interventions
DIAGNOSTIC_TESTSpinChip hs-cTnI
SpinChip Platform, consisting of the SpinChip hs-cTnI test (self-contained cartridge) and SpinChip Analyzer (instrument)
Sponsors
SpinChip Diagnostics ASA
Aurevia
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able and willing to provide signed written informed consent * Subjects ≥ 18 years old * Subjects presenting at the ED with acute chest discomfort including "pain", "pressure", "tightness", "burning", or "stabbing" and/or other symptoms suggestive of AMI such as upper abdominal pain, left shoulder/arm pain, pain in the jaw, or pain between the scapulae.
Exclusion criteria
* Subjects experiencing shock * Self-reported pregnancy * Previously included in the study (e.g., in case of a second presentation) * Patient incapable of judgement, for example due to severe pain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the receiver operating characteristics (AUROC) curve for cTnI concentrations measured at admission to the emergency department (ED) | Day of admission | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUROC for cTnI concentrations measured at 1, 2 and 3 hours after admission to the ED | Day of admission | 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 |
| 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 | Day of admission | 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. |
| 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 | Day of admission | 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. |
| Occurrence of MI and/or cardiovascular death (CV) within 30 days | 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. |
| Derivation and validation of rule-in/rule-out 0/1h and 0/2h algorithms | Day of admission | 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. |
| Incidence of AEs, ADEs and DDs | Day of admission | Assess the safety of the SpinChip Platform, as measured by adverse events (AEs), adverse device effects (ADEs) and device deficiencies (DDs). |
Countries
Denmark, Germany, Norway, Sweden, Switzerland, United Kingdom
Contacts
PRINCIPAL_INVESTIGATORHelge Røsjø, MD/Professor
Akershus University Hospital, Akershus Clinical Research Center (ACR), Norway
PRINCIPAL_INVESTIGATORChristian Müller, MD/Professor
Cardiovascular Research Institute Basel, Switzerland
Outcome results
None listed