Ignite Creation Date:
2024-05-06 @ 1:31 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01830062
Status:
WITHDRAWN
Last Update Posted:
2021-07-02
First Post:
2013-04-08
Brief Title:
Atherosclerotic Coronary Vulnerable Plaque Correlation With Coronary Artery Calcium
Sponsor:
Medstar Health Research Institute
Organization:
Medstar Health Research Institute
Study Overview
Official Title:
Atherosclerotic Coronary Vulnerable Plaque Correlation With Coronary Artery Calcium
Status:
WITHDRAWN
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 coronary segments assessed with near infrared spectroscopy NIRS in patients with symptomatic coronary artery disease CAD
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 will be referred to the study site for clinically indicated non-emergent cardiac catheterization with NIRS evaluation either proceeded or followed by coronary artery calcium score CACS evaluation
Qualifying patients that are referred directly to cardiac catheterization with NIRS assessment secondary to symptoms or abnormal functional test will be sent for cardiac CACS assessment following the catheterization before discharge from the hospital In this group patients who require ad hoc PCI upon initial angiography will be excluded to avoid artifacts on CACS In patients who are referred for a clinically indicated cardiac catheterization with IVUS evaluation within 3 months after MDCT with CACS NIRS of at least two 2 major epicardial vessels will be completed prior to any if necessary coronary revascularization
Qualifying patients that are referred directly to cardiac catheterization with NIRS assessment secondary to symptoms or abnormal functional test will be sent for cardiac CACS assessment following the catheterization before discharge from the hospital In this group patients who require ad hoc PCI upon initial angiography will be excluded to avoid artifacts on CACS In patients who are referred for a clinically indicated cardiac catheterization with IVUS evaluation within 3 months after MDCT with CACS NIRS of at least two 2 major epicardial vessels will be completed prior to any if necessary coronary revascularization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None