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

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.

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: InfraReDx Lipiscan IVUS

Detailed Description

The aims of this study are to:

1. Test the ability of the new NIRS IVUS system to detect lipid pool
2. Evaluate the accuracy of the NIRS IVUS system for localization of lipide rich plaque: superficial vs deep
3. Improve diagnostic accuracy of OCT for detection of lipid using information from NIRS IVUS

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Coronary stenting with OCT, NIRS/IVUS; All subjects will have Near Infrared Spectroscopy/Intravascular Ultrasound Imaging performed.	Device: InfraReDx Lipiscan IVUS; Near Infrared Spectroscopy/Intravascular Ultrasound will be performed following OCT imaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Measured one point in time during cardiac catheterization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Measured at the time of cardiac catheterization

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Infraredx

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): June 1, 2012

Study Registration Dates

• First Submitted: January 3, 2012
• First Submitted That Met QC Criteria: January 9, 2012
• First Posted (ESTIMATE): January 10, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): November 18, 2013
• Last Update Submitted That Met QC Criteria: October 23, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 2010P001608