CompletedNot Applicable

SpinChip Hs-cTnI Clinical Diagnostic Performance

Denmark, Germany, Norway1,551 participantsStarted 2024-07-15

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Area under the receiver operating characteristics (AUROC) curve for cTnI concentrations measured at admission to the emergency department (ED)

Timeframe: Day of admission

Trial details

NCT IDNCT06499519

SponsorSpinChip Diagnostics ASA

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-09-08

View on ClinicalTrials.gov More Acute Myocardial Infarction trials