search
Back to results

Evaluation of a Combined Near Infrared Spectroscopy (NIRS) and Intravascular Ultrasound (IVUS) Catheter for Detection of Lipid Rich Plaque

Primary Purpose

Coronary Artery Disease

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
InfraReDx Lipiscan IVUS
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient Characteristics

  1. Males and non-pregnant females > 18 and < 79 years of age
  2. Patients referred for diagnostic coronary angiography who are found to have lesions in native coronary arteries which will be treated by percutaneous coronary intervention (PCI) (or patients with known coronary lesions who are referred for planned PCI)
  3. Able to give written informed consent

Lesion Characteristics

  1. Lesion in native coronary artery
  2. Angiographic stenosis > 50%
  3. Reference vessel diameter 2.5 mm - 4.0 mm by visual estimation
  4. Subjects who have successful PCI and OCT

General Exclusion Criteria

  1. Subjects who are unable or unwilling to sign the informed consent form
  2. Subjects with serious co-morbid conditions that in judgment of the investigator preclude inclusion in this study (such as terminal cancer, life expectancy < 6 months, Liver Function Tests (LFTs) > 3 times Upper Limit of Normal (ULN), or post-transplant)
  3. Subjects with New York Heart Association (NYHA) class III or IV heart failure or known left ventricular ejection fraction < 30%
  4. Subjects who have experienced an ST-elevation myocardial infarction (STEMI) within 72 hours prior to the procedure
  5. Subjects with hemodynamic or electrical instability (including shock)
  6. Subjects diagnosed with severe, non-catheter-related coronary artery spasm
  7. Subjects who are or may be pregnant
  8. Subjects with known allergies to contrast media
  9. Subjects with renal failure as defined by estimated Glomerular Filtration Rate (eGFR) < 60.
  10. History of Transient Ischemic Attack (TIA) or stroke < 6 months

Lesion Specific Exclusion Criteria These exclusion criteria apply to the target lesion to be imaged by NIRS IVUS.

  1. Lesion located in the left main coronary artery
  2. Lesions that are heavily calcified
  3. Lesions where OCT cannot be performed due to technical difficulties
  4. Other lesions that the investigator deems inappropriate for the procedure such as lesions with excessive tortuosity, presence of thrombus, low flow by TIMI grade.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Coronary stenting with OCT, NIRS/IVUS

Arm Description

All subjects will have Near Infrared Spectroscopy/Intravascular Ultrasound Imaging performed.

Outcomes

Primary Outcome Measures

Detection of Lipid Rich Plaque by Near Infrared Spectroscopy (NIRS) Intravascular Ultrasound (IVUS)
Subjects are presenting for their clinically-indicated cardiac catheterization. NIRS/IVUS imaging will be done at the time of catheterization.

Secondary Outcome Measures

Differences in NIRS Parameters Between Deep and Superficial Lipid Assessed by Optical Coherence Tomography (OCT).
Subjects are presenting for their clinically-indicated cardiac catheterization. NIRS/IVUS imaging will be done at the time of catheterization. Plaques were divided depending on depth of lipid by OCT (cut off value 130 um).

Full Information

First Posted
January 3, 2012
Last Updated
October 23, 2013
Sponsor
Massachusetts General Hospital
Collaborators
Infraredx
search

1. Study Identification

Unique Protocol Identification Number
NCT01506960
Brief Title
Evaluation of a Combined Near Infrared Spectroscopy (NIRS) and Intravascular Ultrasound (IVUS) Catheter for Detection of Lipid Rich Plaque
Official Title
Evaluation of a Combined Near Infrared Spectroscopy (NIRS) and Intravascular Ultrasound (IVUS) Catheter for Detection of Lipid Rich Plaque
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Terminated
Why Stopped
It was felt that a sufficient number of subjects were enrolled.
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Infraredx

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to learn more about lipid rich plaque using Near Infrared Spectroscopy (NIRS)/Intravascular Ultrasound (IVUS) imaging in patients who have had coronary artery stenting and Optical coherence tomography (OCT) imaging.
Detailed Description
The aims of this study are to: Test the ability of the new NIRS IVUS system to detect lipid pool Evaluate the accuracy of the NIRS IVUS system for localization of lipide rich plaque: superficial vs deep Improve diagnostic accuracy of OCT for detection of lipid using information from NIRS IVUS

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
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coronary stenting with OCT, NIRS/IVUS
Arm Type
Experimental
Arm Description
All subjects will have Near Infrared Spectroscopy/Intravascular Ultrasound Imaging performed.
Intervention Type
Device
Intervention Name(s)
InfraReDx Lipiscan IVUS
Intervention Description
Near Infrared Spectroscopy/Intravascular Ultrasound will be performed following OCT imaging.
Primary Outcome Measure Information:
Title
Detection of Lipid Rich Plaque by Near Infrared Spectroscopy (NIRS) Intravascular Ultrasound (IVUS)
Description
Subjects are presenting for their clinically-indicated cardiac catheterization. NIRS/IVUS imaging will be done at the time of catheterization.
Time Frame
Measured one point in time during cardiac catheterization
Secondary Outcome Measure Information:
Title
Differences in NIRS Parameters Between Deep and Superficial Lipid Assessed by Optical Coherence Tomography (OCT).
Description
Subjects are presenting for their clinically-indicated cardiac catheterization. NIRS/IVUS imaging will be done at the time of catheterization. Plaques were divided depending on depth of lipid by OCT (cut off value 130 um).
Time Frame
Measured at the time of cardiac catheterization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient Characteristics Males and non-pregnant females > 18 and < 79 years of age Patients referred for diagnostic coronary angiography who are found to have lesions in native coronary arteries which will be treated by percutaneous coronary intervention (PCI) (or patients with known coronary lesions who are referred for planned PCI) Able to give written informed consent Lesion Characteristics Lesion in native coronary artery Angiographic stenosis > 50% Reference vessel diameter 2.5 mm - 4.0 mm by visual estimation Subjects who have successful PCI and OCT General Exclusion Criteria Subjects who are unable or unwilling to sign the informed consent form Subjects with serious co-morbid conditions that in judgment of the investigator preclude inclusion in this study (such as terminal cancer, life expectancy < 6 months, Liver Function Tests (LFTs) > 3 times Upper Limit of Normal (ULN), or post-transplant) Subjects with New York Heart Association (NYHA) class III or IV heart failure or known left ventricular ejection fraction < 30% Subjects who have experienced an ST-elevation myocardial infarction (STEMI) within 72 hours prior to the procedure Subjects with hemodynamic or electrical instability (including shock) Subjects diagnosed with severe, non-catheter-related coronary artery spasm Subjects who are or may be pregnant Subjects with known allergies to contrast media Subjects with renal failure as defined by estimated Glomerular Filtration Rate (eGFR) < 60. History of Transient Ischemic Attack (TIA) or stroke < 6 months Lesion Specific Exclusion Criteria These exclusion criteria apply to the target lesion to be imaged by NIRS IVUS. Lesion located in the left main coronary artery Lesions that are heavily calcified Lesions where OCT cannot be performed due to technical difficulties Other lesions that the investigator deems inappropriate for the procedure such as lesions with excessive tortuosity, presence of thrombus, low flow by TIMI grade.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ik-Kyung Jang, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Evaluation of a Combined Near Infrared Spectroscopy (NIRS) and Intravascular Ultrasound (IVUS) Catheter for Detection of Lipid Rich Plaque

We'll reach out to this number within 24 hrs