SpinChip Hs-cTnI Clinical Diagnostic Performance

Launched by SPINCHIP DIAGNOSTICS ASA · Jul 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new test called the SpinChip hs-cTnI test, which measures a protein called troponin I in the blood. Troponin I is released when the heart muscle is damaged, such as during a heart attack. The goal of this study is to see how well the SpinChip test can help doctors diagnose heart attacks compared to another established testing method. Researchers are looking to gather information on how accurate and safe this new test is.

To be eligible for the trial, participants need to be at least 18 years old and able to give consent for the study. They should also be visiting the emergency department with symptoms like chest pain, pressure, or discomfort in the arms, jaw, or upper abdomen that could suggest a heart attack. Participants can expect to have their blood tested using both the new SpinChip method and the standard method to compare the results. It’s important to note that people who are in shock, pregnant, or unable to provide clear judgment due to severe pain will not be included in the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • Subjects experiencing shock
• • Self-reported pregnancy
• • Previously included in the study (e.g., in case of a second presentation)
• • Patient incapable of judgement, for example due to severe pain