Determination of the 99th Percentile Upper Reference Limits (URLs) for the SpinChip High Sensitivity Cardiac Troponin I (SpinChip Hs-cTnI) Test

Status: Recruiting
Location: See all (2) 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. Low levels of troponin are also present in the blood stream of healthy individuals and can be detected by high-sensitive troponin tests. 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 determine the upper reference limits (URLs) for the SpinChip hs-cTnI test in a healthy population.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• Able and willing to provide signed written informed consent

• 18-80 years old

• Estimated glomerular filtration rate (eGFR) \> 60 mL/min/1.73 m2 for subjects 18-65 years and \> 50 mL/min/1.73 m2 for subjects \> 66 years

• Haemoglobin A1c (HbA1c) \< 6.5% (\< 48 mmol/mol)

• NT-proBNP (N-terminal prohormone of brain natriuretic peptide) \< 125 ng/L or BNP (brain natriuretic peptide) \< 35 ng/L

Locations
Other Locations
Sweden
Phase I-IV Research Unit Karolinska
RECRUITING
Solna
CTC Clinical Trial Consultants AB
RECRUITING
Uppsala
Contact Information
Primary
Gro Leite Størvold, PhD
gls@spinchip.no; clinicaltrial@spinchip.no
+47 95203051
Backup
Anna Säfström
anna.safstrom@scro.se
+46 18 10 05 50
Time Frame
Start Date: 2024-05-20
Estimated Completion Date: 2025-08-30
Participants
Target number of participants: 1600
Related Therapeutic Areas
Sponsors
Leads: SpinChip Diagnostics ASA
Collaborators: CTC Clinical Trial Consultants AB, Aurevia

This content was sourced from clinicaltrials.gov