Clinical Diagnostic Performance of the SpinChip High-sensitivity Cardiac Troponin I (SpinChip Hs-cTnI) Test

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Aarhus Universitetshospital
RECRUITING
Aarhus
Germany
Universitätsmedizin Göttingen (University Medical Center Göttingen)
RECRUITING
Göttingen
Norway
Haukland University Hospital, Department of Heart Disease
RECRUITING
Bergen
Akershus University hospital, Akershus Clinical Research Center (ACR)
RECRUITING
Lørenskog
Sweden
Danderyd University Hospital
RECRUITING
Danderyd
Switzerland
University hospital Basel, Cardiovascular Research Institute of Basel (CRIB)
RECRUITING
Basel
Luzerner Kantonsspital
RECRUITING
Lucerne
United Kingdom
Royal Infirmary of Edinburgh
RECRUITING
Edinburgh
Contact Information
Primary
Gro Leite Størvold, PhD
clinicaltrial@spinchip.no
+47 95203051
Backup
Anna Säfström
anna.safstrom@scro.se
+46 18 10 05 50
Time Frame
Start Date: 2024-07-15
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 1200
Related Therapeutic Areas
Sponsors
Leads: SpinChip Diagnostics ASA
Collaborators: Aurevia

This content was sourced from clinicaltrials.gov