NCT06499519Completed
SpinChip Hs-cTnI Clinical Diagnostic Performance
Clinical Diagnostic Performance of the SpinChip High-sensitivity Cardiac Troponin I (SpinChip Hs-cTnI) Test
Source: ClinicalTrials.gov · Last updated 26 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1551 (actual)
- First submitted
- 5 Jul 2024
- Start date
- 15 Jul 2024
- Primary completion date
- 8 Sept 2025
- Lead sponsor
- SpinChip Diagnostics ASA
- Diseases
- Coronary artery disease
- NCT number
- NCT06499519
What you commit to
- Study type: Observational
- Participants enrolled: 1551
- From 15 Jul 2024 to the primary completion date, 8 Sept 2025
- 9 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously included in the study (e.g., in case of a second presentation)
Other
- Subjects experiencing shock
- Self-reported pregnancy
- Patient incapable of judgement, for example due to severe pain
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University hospital Basel, Cardiovascular Research Institute of Basel (CRIB) Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Luzerner Kantonsspital Coordinator of this site? Confirm its status | Lucerne | Switzerland | Unknown status |
| Universitätsmedizin Göttingen (University Medical Center Göttingen) Coordinator of this site? Confirm its status | Göttingen | Germany | Unknown status |
| Aarhus Universitetshospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
| Royal Infirmary of Edinburgh Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
| Royal Alexandra Hospital Coordinator of this site? Confirm its status | Paisley | United Kingdom | Unknown status |
| Haukland University Hospital, Department of Heart Disease Coordinator of this site? Confirm its status | Bergen | Norway | Unknown status |
| Akershus University hospital, Akershus Clinical Research Center (ACR) Coordinator of this site? Confirm its status | Lørenskog | Norway | Unknown status |
| Danderyd University Hospital Coordinator of this site? Confirm its status | Danderyd | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.