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Atherosclerotic Coronary Vulnerable Plaque: Correlation With Coronary Artery Calcium

Primary Purpose

Coronary Artery Disease

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

NIRS

CACS

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Arm Label

CACS and NIRS

Arm Description

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.

Outcomes

Primary Outcome Measures

Correlation between CACS and LCBI

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.

Secondary Outcome Measures

Vessel level correlation of CACS and LCBI

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

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

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

Full Information

NCT ID

NCT01830062

First Posted

April 8, 2013

Last Updated

June 30, 2021

Sponsor

Medstar Health Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT01830062

Brief Title

Atherosclerotic Coronary Vulnerable Plaque: Correlation With Coronary Artery Calcium

Official Title

Atherosclerotic Coronary Vulnerable Plaque: Correlation With Coronary Artery Calcium

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Withdrawn

Why Stopped

lack of funding

Study Start Date

November 2013 (Anticipated)

Primary Completion Date

January 2019 (Anticipated)

Study Completion Date

June 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medstar Health Research Institute

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CACS and NIRS

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

NIRS

Other Intervention Name(s)

LipiScan Coronary Imaging System, InfraReDx, Inc.

Intervention Description

Near infrared spectroscopy of at least 2 major epicardial vessels

Intervention Type

Other

Intervention Name(s)

CACS

Intervention Description

Coronary artery calcium score assessed by multi-slice computed tomography

Primary Outcome Measure Information:

Title

Correlation between CACS and LCBI

Description

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.

Time Frame

maximum duration of 3 months between CACS and NIRS

Secondary Outcome Measure Information:

Title

Vessel level correlation of CACS and LCBI

Description

Vessel level and individual coronary artery level (LM, LAD, LCx, RCA) analysis of CACS with max LCBI4mm and total LCBI for the vessel imaged

Time Frame

maximum of 3 months between CACS and NIRS

Title

Vessel level comparison of angiographic and IVUS parameters

Description

Vessel level comparison of angiographic and IVUS parameters with yellow plaque defined by LCBI (both max LCBI4mm and total vessel LCBI)

Time Frame

maximum of 3 months between CACS and NIRS

Title

Segment level analysis of CACS, IVUS and lipid core plaque in patients with abnormal CT

Description

Time Frame

maximum of 3 months between CACS and NIRS

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ron Waksman, MD

Organizational Affiliation

Medstar Washington Hospital Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

MedStar Washington Hospital Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20010

Country

United States

12. IPD Sharing Statement

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Atherosclerotic Coronary Vulnerable Plaque: Correlation With Coronary Artery Calcium

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