Atherosclerotic Coronary Vulnerable Plaque: Correlation With Coronary Artery Calcium

NCT ID: NCT01830062

Last Updated: 2021-07-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2021-06-30

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

NIRS

Intervention Type: OTHER

Near infrared spectroscopy of at least 2 major epicardial vessels

CACS

Intervention Type: OTHER

Coronary artery calcium score assessed by multi-slice computed tomography

Interventions

NIRS

Near infrared spectroscopy of at least 2 major epicardial vessels

Intervention Type: OTHER

CACS

Coronary artery calcium score assessed by multi-slice computed tomography

Intervention Type: OTHER

Other Intervention Names

LipiScan Coronary Imaging System, InfraReDx, Inc.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medstar Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ron Waksman, MD

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Locations

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

CACS NIRS

Identifier Type: -

Identifier Source: org_study_id