Atherosclerotic Coronary Vulnerable Plaque: Correlation With Coronary Artery Calcium
Coronary Artery Disease
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- Patient is ≥18 years of age
- Patient is clinically indicated due to angina, abnormal functional test or other ischemic symptoms to undergo non-emergent cardiac catheterization with IVUS evaluation i.If the patient has not had a cardiac MDCT with CACS meeting the protocol requirements within 3 months prior to the cardiac catheterization, the patient is able to undergo CACS following LipiScan IVUS and NIRS evaluation, prior to any coronary revascularization ii. If the patient has had a cardiac MDCT evaluation with CACS meeting the protocol requirements within 3 months prior to the cardiac catheterization, LipiScan IVUS and NIRS imaging will be completed in at least two (2) major epicardial vessels prior to any coronary revascularization
At least two (2) major epicardial native vessels are suitable for interrogation by LipiScan IVUS imaging and NIRS evaluation, defined as:
i.At least 30 mm of vessel that is > 2.0mm in diameter ii.No other contraindications to imaging
- No contraindications for LipiScan IVUS and NIRS evaluation
- No contraindications for CACS evaluation by MDCT
- Subject must be able to provide informed consent form and comply with the protocol requirements
Exclusion Criteria:
- Evidence of clinical hemodynamic instability in the 6 hours before either procedure
- Prior history of percutaneous coronary intervention (PCI) with stent placement
- Prior history of bypass grafts
- Female subject that is pregnant or lactating
- Any other factor that the investigator feels would put the patient at increased risk or otherwise make the patient unsuitable for participation in the protocol
Sites / Locations
- MedStar Washington Hospital Center
Arms of the Study
Arm 1
Experimental
CACS and NIRS
All patients will undergo NIRS to at least 2 major epicardial vessels as a research related intervention. Patients will be considered to be enrolled in the trial upon completion NIRS evaluation. Patients who had a clinically indicated CT with CACS evaluation within 3 months prior to the cardiac catheterization with NIRS evaluation will not have any other research related interventions. Patients who have not had a clinically indicated CT with CACS within 3 months prior to the cardiac catheterization with NIRS evaluation will have the CACS after NIRS imaging prior to discharge from the hospital.