NCT06453707Completed
SpinChip Hs-cTnI Sample Type Validation
Sample Type Validation: Finger Prick and Plasma vs Whole Blood in a Clinical Setting for the SpinChip High-sensitivity Cardiac Troponin I (SpinChip Hs-cTnI) Test
Source: ClinicalTrials.gov · Last updated 22 Aug 2024
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 demonstrate that different types of blood samples (finger prick, venous whole blood and plasma) return comparable results when analysed using the SpinChip hs-cTnI test. Blood samples from at least 150 patients will be analyzed and the testing will be carried out by healthcare personnel.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 180 (actual)
- First submitted
- 29 May 2024
- Start date
- 12 Apr 2024
- Primary completion date
- 3 Jul 2024
- Lead sponsor
- SpinChip Diagnostics ASA
- Diseases
- Coronary artery disease
- NCT number
- NCT06453707
What you commit to
- Study type: Observational
- Participants enrolled: 180
- From 12 Apr 2024 to the primary completion date, 3 Jul 2024
- 1 site 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 measuring range of the SpinChip hs-cTnI test
Other illness
- Cognitive impairment precluding informed consent
- General clinical condition which affects the patient in a major way and the patient is considered to be in an unstable clinical condition
Other
- Self-reported pregnancy
Who the study is looking for
- Able and willing to provide signed written informed consent
- Subjects \>18 years old
- Clinical cardiac Troponin T concentration available
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
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 |
This page is information, not medical advice. Discuss any trial with your doctor.