Atherosclerotic Coronary Vulnerable Plaque: Correlation With Coronary Artery Calcium

NCT01830062 | Withdrawn

• 1 other identifier: CACS NIRS
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  maximum duration of 3 months between CACS and NIRS

Secondary Outcomes (3)

• Vessel level correlation of CACS and LCBI

  maximum of 3 months between CACS and NIRS

• Vessel level comparison of angiographic and IVUS parameters

  maximum of 3 months between CACS and NIRS

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

  maximum of 3 months between CACS and NIRS

Study Arms (1)

CACS and NIRS

EXPERIMENTAL

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.

Other: NIRS; Other: CACS

Interventions

NIRS OTHER

Near infrared spectroscopy of at least 2 major epicardial vessels

Also known as: LipiScan Coronary Imaging System, InfraReDx, Inc.

CACS and NIRS

CACS OTHER

Coronary artery calcium score assessed by multi-slice computed tomography

CACS and NIRS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Ron Waksman, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 12, 2013
• Study Start: November 1, 2013
• Primary Completion: January 1, 2019
• Study Completion: June 1, 2021
• Last Updated: July 2, 2021

Record last verified: 2021-06

Locations

US (1)