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:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT04272060
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 45-85 years with history of CHD will be asked to participate. History of CHD is defined as prior documentation of a coronary artery stenosis of 50% or greater by coronary angiography or by prior documentation of coronary artery revascularization by percutaneous coronary intervention (PCI). Women of child bearing potential must demonstrate a negative pregnancy test within 24 hours of the study CTA.
* Suspected obstructive coronary artery stenosis based on clinical history and/or noninvasive testing, prompting a clinical referral for invasive coronary angiography; and/or planned PCI within the next 60 days.
* Ability to understand and willingness to sign the Informed Consent Form.
Exclusion Criteria:
* Known allergy to iodinated contrast media
* History of multiple myeloma or previous organ transplantation
* Elevated serum creatinine (\> 1.5mg/dl) or calculated creatinine clearance of \< 60 ml/min (using the Cockcroft-Gault formula
* Atrial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block (second or third-degree heart block)
* Evidence of severe symptomatic heart failure (NYHA Class III or IV);
* Known or suspected moderate or severe aortic stenosis
* Previous coronary artery bypass or other cardiac surgery
* Patients without a history of CHD who had no or only mild coronary calcification on chest CT imaging within the past 5 years or had most recent coronary calcium scan with a score \<400
* Suspected acute coronary syndrome
* Presence of any other history or condition that the investigator feels would be problematic
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
85 Years
Study:
NCT04272060
Study Brief:
Protocol Section:
NCT04272060