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

This study has been terminated.
(It was felt that a sufficient number of subjects were enrolled.)
Sponsor:
Collaborator:
InfraReDx
Information provided by (Responsible Party):
Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01506960
First received: January 3, 2012
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Coronary Artery Disease
Device: InfraReDx Lipiscan IVUS
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Detection of Lipid Rich Plaque by Near Infrared Spectroscopy (NIRS) Intravascular Ultrasound (IVUS) [ Time Frame: Measured one point in time during cardiac catheterization ] [ Designated as safety issue: No ]
    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). [ Time Frame: Measured at the time of cardiac catheterization ] [ Designated as safety issue: No ]
    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).


Enrollment: 64
Study Start Date: January 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01506960

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

No publications provided

Responsible Party: Ik-Kyung Jang, MD, PhD, Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01506960     History of Changes
Other Study ID Numbers: 2010P001608
Study First Received: January 3, 2012
Results First Received: May 16, 2013
Last Updated: October 23, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014