Clinical trial NCT06499519: SpinChip Hs-cTnI Clinical Diagnostic Performance
Official title: Clinical Diagnostic Performance of the SpinChip High-sensitivity Cardiac Troponin I (SpinChip Hs-cTnI) Test
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Myocardial Infarction
Keywords: Acute Myocardial Infarction
High-sensitive
Point of Care
Troponin I
Near-patient test
Heart attack
Diagnostic accuracy
Lead sponsor: SpinChip Diagnostics ASA
Sponsor class: INDUSTRY
Collaborators: name: Aurevia
First posted: 2024-07-12
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects presenting to the emergency department with acute chest discomfort or other symptoms suggestive of AMI. This multicentre study will be conducted at up to 10 sites in the EU/EEA, Switzerland and UK.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Area under the receiver operating characteristics (AUROC) curve for cTnI concentrations measured at admission to the emergency department (ED)
timeFrame: Day of admission
Secondary outcomes:
measure: AUROC for cTnI concentrations measured at 1, 2 and 3 hours after admission to the ED
timeFrame: Day of admission
measure: 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
timeFrame: Day of admission
measure: 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
timeFrame: Day of admission
measure: Occurrence of MI and/or cardiovascular death (CV) within 30 days
timeFrame: 30 days
measure: Derivation and validation of rule-in/rule-out 0/1h and 0/2h algorithms
timeFrame: Day of admission
measure: Incidence of AEs, ADEs and DDs
timeFrame: Day of admission
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen (University Medical Center Göttingen)
city: Lørenskog
country: Norway
facility: Akershus University hospital, Akershus Clinical Research Center (ACR)
state: Akerhus
city: Bergen
country: Norway
facility: Haukland University Hospital, Department of Heart Disease
state: Vestland
city: Danderyd
country: Sweden
facility: Danderyd University Hospital
city: Basel
country: Switzerland
facility: University hospital Basel, Cardiovascular Research Institute of Basel (CRIB)
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
Study officials:
affiliation: Akershus University Hospital, Akershus Clinical Research Center (ACR), Norway
name: Helge Røsjø, MD/Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiovascular Research Institute Basel, Switzerland
name: Christian Müller, MD/Professor
role: PRINCIPAL_INVESTIGATOR
References: