Evaluation of a new test for diagnosing heart attacks
Clinical Diagnostic Performance of the SpinChip High-sensitivity Cardiac Troponin I (SpinChip Hs-cTnI) Test
SpinChip Diagnostics ASA · NCT06499519
This study is testing a new quick blood test to see if it can accurately diagnose heart attacks in adults who have chest pain or other related symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | SpinChip Diagnostics ASA (industry) |
| Locations | 8 sites (Aarhus and 7 other locations) |
| Trial ID | NCT06499519 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the diagnostic accuracy and safety of the SpinChip high-sensitivity cardiac troponin I (hs-cTnI) test in patients presenting with symptoms of acute myocardial infarction (AMI). The SpinChip test allows for rapid measurement of troponin I levels in blood samples, providing results within 10 minutes, significantly faster than traditional laboratory methods. The study will involve multiple centers and will compare the performance of the SpinChip test to a clinically validated hs-cTnI method. Participants will include adults experiencing acute chest discomfort or other symptoms suggestive of a heart attack.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older presenting with acute chest discomfort or symptoms suggestive of a heart attack.
Not a fit: Patients experiencing shock, self-reported pregnancy, or those incapable of judgment due to severe pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this test could enable quicker and more accurate diagnosis of heart attacks, potentially improving patient outcomes.
How similar studies have performed: Other studies have shown success with high-sensitivity troponin tests, indicating that this approach is promising and builds on existing research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aarhus and 7 other locations
- Aarhus Universitetshospital — Aarhus, Denmark (RECRUITING)
- Universitätsmedizin Göttingen (University Medical Center Göttingen) — Göttingen, Germany (RECRUITING)
- Akershus University hospital, Akershus Clinical Research Center (ACR) — Lørenskog, Akerhus, Norway (RECRUITING)
- Haukland University Hospital, Department of Heart Disease — Bergen, Vestland, Norway (RECRUITING)
- Danderyd University Hospital — Danderyd, Sweden (RECRUITING)
- University hospital Basel, Cardiovascular Research Institute of Basel (CRIB) — Basel, Switzerland (RECRUITING)
- Luzerner Kantonsspital — Luzern, Switzerland (RECRUITING)
- Royal Infirmary of Edinburgh — Edinburgh, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Helge Røsjø, MD/Professor — Akershus University Hospital, Akershus Clinical Research Center (ACR), Norway
- Study coordinator: Gro Leite Størvold, PhD
- Email: clinicaltrial@spinchip.no
- Phone: +47 95203051
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Myocardial Infarction, High-sensitive, Point of Care, Troponin I, Near-patient test, Heart attack, Diagnostic accuracy