Atherosclerotic Coronary Vulnerable Plaque: Correlation With Coronary Artery Calcium
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|ClinicalTrials.gov Identifier: NCT01830062|
Recruitment Status : Active, not recruiting
First Posted : April 12, 2013
Last Update Posted : June 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Other: NIRS Other: CACS||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Atherosclerotic Coronary Vulnerable Plaque: Correlation With Coronary Artery Calcium|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||May 2019|
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.
Near infrared spectroscopy of at least 2 major epicardial vessels
Other Name: LipiScan Coronary Imaging System, InfraReDx, Inc.
Coronary artery calcium score assessed by multi-slice computed tomography
- Correlation between CACS and LCBI [ Time Frame: maximum duration of 3 months between CACS and NIRS ]The primary endpoint for this study is individual patient level correlation between the total CACS of the entire coronary tree with the max LCBI4mm within the vessels imaged.
- Vessel level correlation of CACS and LCBI [ Time Frame: maximum of 3 months between CACS and NIRS ]Vessel level and individual coronary artery level (LM, LAD, LCx, RCA) analysis of CACS with max LCBI4mm and total LCBI for the vessel imaged
- Vessel level comparison of angiographic and IVUS parameters [ Time Frame: maximum of 3 months between CACS and NIRS ]Vessel level comparison of angiographic and IVUS parameters with yellow plaque defined by LCBI (both max LCBI4mm and total vessel LCBI)
- Segment level analysis of CACS, IVUS and lipid core plaque in patients with abnormal CT [ Time Frame: maximum of 3 months between CACS and NIRS ]In subset of patient where coronary angiography and NIRS is driven by patient with abnormal CT coronary angiogram, the CT angiographic parameters are utilized for Segment level analysis between the CACS, IVUS and lipid core plaque
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01830062
|United States, District of Columbia|
|MedStar Washington Hospital Center|
|Washington, District of Columbia, United States, 20010|
|Principal Investigator:||Ron Waksman, MD||Medstar Washington Hospital Center|