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

• ClinicalTrials.gov Identifier: NCT01506960
• Recruitment Status: Terminated
• First Posted: January 10, 2012
• Results First Posted: October 18, 2013
• Last Update Posted: November 18, 2013
• Sponsor: Massachusetts General Hospital
• Collaborator: Infraredx
• Information provided by (Responsible Party): Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital

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.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease	Device: InfraReDx Lipiscan IVUS	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 64 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Evaluation of a Combined Near Infrared Spectroscopy (NIRS) and Intravascular Ultrasound (IVUS) Catheter for Detection of Lipid Rich Plaque
• Study Start Date: January 2012
• Actual Primary Completion Date: June 2012
• Actual Study Completion Date: June 2012

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Detection of Lipid Rich Plaque by Near Infrared Spectroscopy (NIRS) Intravascular Ultrasound (IVUS) [ Time Frame: Measured one point in time during cardiac catheterization ]
   Subjects are presenting for their clinically-indicated cardiac catheterization. NIRS/IVUS imaging will be done at the time of catheterization.

Secondary Outcome Measures :

1. Differences in NIRS Parameters Between Deep and Superficial Lipid Assessed by Optical Coherence Tomography (OCT). [ Time Frame: Measured at the time of cardiac catheterization ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 79 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Infraredx

Investigators

• Principal Investigator: Ik-Kyung Jang, MD, PhD; Massachusetts General Hospital

More Information

• Responsible Party: Ik-Kyung Jang, MD, PhD, Professor of Medicine, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT01506960
• Other Study ID Numbers: 2010P001608
• First Posted: January 10, 2012
• Results First Posted: October 18, 2013
• Last Update Posted: November 18, 2013
• Last Verified: October 2013

Additional relevant MeSH terms:

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