Status:
WITHDRAWN
Atherosclerotic Coronary Vulnerable Plaque: Correlation With Coronary Artery Calcium
Lead Sponsor:
Medstar Health Research Institute
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this study is to compare the relationship between the coronary artery calcification assessed by MDCT with the plaque characteristics and necrotic lipid core content of non-intervened corona...
Detailed Description
A total of 60 patients, from a single center, who meet all of the study inclusion criteria and none of the study exclusion criteria will be prospectively enrolled in this study. Qualifying patients wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01830062
Start Date
November 1 2013
End Date
June 1 2021
Last Update
July 2 2021
Active Locations (1)
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1
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010