About this trial
The primary objective of this study is to determine whether a reduced radiation protocol (RRP) in which angiograms are acquired at ultralow radiation doses and then processed using spatiotemporal enhancement software can produce similar quality angiographic images as compared with standard techniques.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Referred for clinically indicated coronary angiography
≥18 years of age
Not pregnant
English speaking
Disqualifiers
Hemodynamically or electrically unstable.
Indication for coronary angiography is emergent, including ST-segment elevation myocardial infarction
History of coronary artery bypass grafting
An eGFR <60
Trial population
Patients suspected to have coronary artery disease (CAD) who are undergoing diagnostic coronary angiography with or without possible percutaneous coronary intervention (PCI).
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Segment-level percent diameter stenosis (%DS)
Segment-level quantitative coronary angiography (QCA) determination of percent diameter stenosis (%DS)
Secondary outcomes
Stenosis severity
Agreement in reader-adjudication of segment-level identification of mild/intermediate/severe stenosis
Diagnostic quality
Percent of coronary segments qualitatively determined to be of adequate diagnostic image quality
Radiation dose - SOC
Radiation dose (air kerma and dose-area product) for SOC-angiograms
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: