NCT06851013Completed
SpinChip Hs-cTnI Multisite Precision
Multisite Precision Study for the SpinChip High-sensitivity Cardiac Troponin I (SpinChip Hs-cTnI) Test
Source: ClinicalTrials.gov · Last updated 14 May 2025
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 establish the precision of the SpinChip hs-cTnI test when using Li-Heparin plasma and whole blood samples in the hands of the intended user in the intended use setting at multiple sites.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 37 (actual)
- First submitted
- 19 Feb 2025
- Start date
- 3 Feb 2025
- Primary completion date
- 28 Mar 2025
- Lead sponsor
- SpinChip Diagnostics ASA
- Diseases
- Coronary artery disease
- NCT number
- NCT06851013
What you commit to
- Study type: Observational
- Participants enrolled: 37
- From 3 Feb 2025 to the primary completion date, 28 Mar 2025
- 3 sites in 1 country
- 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 with a sample within the required concentration ranges for the SpinChip hs-cTnI test
Other illness
- Cognitive impairment precluding informed consent
- General clinical condition that affects the patient in a major way and the patient is considered to be in an unstable clinical condition
Other
- Self-reported pregnancy
- No venous blood sample collected for the study
Who the study is looking for
- Able and willing to provide signed written informed consent
- Subjects \>18 years old
- Clinical cTn concentrations available
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Akershus University hospital, Akershus Clinical Research Center (ACR) Coordinator of this site? Confirm its status | Lørenskog | Norway | Unknown status |
| SpinChip Diagnostics Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
| Vestre Viken Bærum Hospital Coordinator of this site? Confirm its status | Sandvika | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.