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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01506960
• Other study ID #: 2010P001608
• Status: Terminated
• Phase: Phase 4
• First received: January 3, 2012
• Last updated: October 23, 2013
• Start date: January 2012
• Est. completion date: June 2012

Study information

• Verified date: October 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• InfraReDx Lipiscan IVUS
Near Infrared Spectroscopy/Intravascular Ultrasound will be performed following OCT imaging.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	InfraReDx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No