Clinical Diagnostic Performance of the SpinChip hs-cTnI test
Research type
Research Study
Full title
Clinical Diagnostic Performance of the SpinChip high-sensitivity cardiac troponin I (SpinChip hs-cTnI) test
IRAS ID
334678
Contact name
Alasdair Gray
Contact email
Sponsor organisation
SpinChip Diagnostics
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 30 days
Research summary
During a heart attack, cardiac muscle cells are injured and release the protein troponin I (cTnI) into the bloodstream. Hence, measuring cTnI levels in the blood is routinely performed in hospital laboratories to aid in the diagnosis of heart attack (Acute Myocardial Infarction [AMI]).
The SpinChip high-sensitivity cardiac Troponin I (hs-cTnI) test is intended for near-patient testing for subjects arriving at the hospital emergency department (ED) and Emergency Assessment areas with acute chest discomfort or other symptoms suggestive of Acute Myocardial Infarction (AMI). The results are obtained within 10 minutes.
The purpose of this study is to investigate the diagnostic performance of the SpinChip hs-cTnI test in the emergency department and Emergency Assessment areas, providing data regarding safety and accuracy of the novel testing system compared to the diagnostic performance of established clinically validated laboratory hs-cTnI assays.
Up to 1200 subjects arriving at the hospital emergency department and Emergency Assessment areaswith acute chest discomfort or other symptoms suggestive of Acute Myocardial Infarction (AMI) will be recruited to the study. Each subjects’ involvement in the study will be a screening/enrolment visit where venous blood samples will be collected from the subjects for measuring cTnI at up to 4 timepoints. A follow-up contact will be performed by the study site after 30 days to inquire about the subjects’ health status.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
24/WM/0242
Date of REC Opinion
19 Dec 2024
REC opinion
Further Information Favourable Opinion