Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07464704
Eligibility Criteria:
Inclusion Criteria:
* Signed Informed Consent
* Age: ≥18 years
* Symptomatic patients undergoing evaluation for suspected acute coronary syndrome, defined as symptoms lasting \>20 minutes, and who present to a healthcare facility within 24 hours after symptom onset.
* Included study subjects are those with HEART risk score \> 4, and for whom CT angiography or invasive coronary angiography is intended.
* The Infrasensor should only be used in alert patients who are able to keep the device still for the 5-minute measurement duration, who have clean, intact skin at the measurement site, and who do not have blood pressure cuffs, IV lines, or other medical equipment on the arm used for measurement.
Exclusion Criteria:
* Inclusion criteria:
Signed Informed Consent Age: ≥18 years Symptomatic patients undergoing evaluation for suspected acute coronary syndrome, defined as symptoms lasting \>20 minutes, and who present to a healthcare facility within 24 hours after symptom onset.
Included study subjects are those with HEART risk score \> 4, and for whom CT angiography or invasive coronary angiography is intended.
The Infrasensor should only be used in alert patients who are able to keep the device still for the 5-minute measurement duration, who have clean, intact skin at the measurement site, and who do not have blood pressure cuffs, IV lines, or other medical equipment on the arm used for measurement.
Exclusion criteria:
* Patients with scars, open wounds, or lesions that may interfere with the Infrasensor application
* Patients triaged directly with STEMI or for cardiac reasons other than suspected AMI requiring immediate medical intervention (aortic dissection, unstable cardiac arrhythmias, left bundle branch blocks)
* Patients in whom an obvious alternative diagnosis is suspected at the time of arrival to hospital and without suspicion of ACS (ischemic cardiomyopathy, pulmonary hypertension, chronic total occlusion)
* Patients with acute myocardial infarction, percutaneous coronary intervention (including coronary stent placement), and/or coronary artery bypass graft surgery within the past 30 days
* Patients with unstable angina, hospitalization for acute coronary syndrome, or hemodynamic instability (e.g., cardiogenic shock, malignant arrhythmias) within the past 30 days
* Patients with planned coronary revascularization procedures (PCI or CABG) during the study period
* Hemodynamically unstable patients as defined by institution's protocol
* Exsanguination patients
* Trauma patients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07464704
Study Brief:
Protocol Section:
NCT07464704