Trial Outcomes & Findings for Evaluation of a Combined Near Infrared Spectroscopy (NIRS) and Intravascular Ultrasound (IVUS) Catheter for Detection of Lipid Rich Plaque (NCT NCT01506960)

Results Overview

Subjects are presenting for their clinically-indicated cardiac catheterization. NIRS/IVUS imaging will be done at the time of catheterization.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

64 participants

Primary outcome timeframe

Measured one point in time during cardiac catheterization

Results posted on

2013-11-18

Participant Flow

Participant milestones

Participant milestones
Measure	Coronary Stenting With OCT, NIRS/IVUS All subjects will have Near Infrared Spectroscopy/Intravascular Ultrasound Imaging performed.
Overall Study STARTED	64
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	47

Reasons for withdrawal

Reasons for withdrawal
Measure	Coronary Stenting With OCT, NIRS/IVUS All subjects will have Near Infrared Spectroscopy/Intravascular Ultrasound Imaging performed.
Overall Study Did not meet angiographic criteria	47

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects Having NIRS/IVUS and OCT Imaging During PCI. n=17 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=93 Participants
Age, Categorical >=65 years	5 Participants n=93 Participants
Age Continuous	59.8 years STANDARD_DEVIATION 8.5 • n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	14 Participants n=93 Participants
Region of Enrollment United States	17 participants n=93 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Subjects Having NIRS/IVUS and OCT Imaging During PCI. n=17 Participants	Deep Lipid
Detection of Lipid Rich Plaque by Near Infrared Spectroscopy (NIRS) Intravascular Ultrasound (IVUS)	90 % pts with lipid on NIRS and OCT	—

SECONDARY outcome

Timeframe: Measured at the time of cardiac catheterization

Population: Per protocol

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).

Outcome measures

Outcome measures
Measure	Subjects Having NIRS/IVUS and OCT Imaging During PCI. n=9 Lesions	Deep Lipid n=9 Lesions
Differences in NIRS Parameters Between Deep and Superficial Lipid Assessed by Optical Coherence Tomography (OCT).	5.5 mm (LCP length) Standard Deviation 2.8	4.1 mm (LCP length) Standard Deviation 3.1

Adverse Events

Subjects Having NIRS/IVUS and OCT Imaging During PCI.

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Subjects Having NIRS/IVUS and OCT Imaging During PCI. n=17 participants at risk
Musculoskeletal and connective tissue disorders Back pain post procedure	11.8% 2/17 • Number of events 2
Musculoskeletal and connective tissue disorders Non-ischemic chest pain	5.9% 1/17 • Number of events 1
Cardiac disorders Post-procedural myocardial infarction	5.9% 1/17 • Number of events 1
Cardiac disorders PVCs during NIRS IVUS	5.9% 1/17 • Number of events 1

Additional Information

Iris McNulty

Massachusetts General Hospital

Phone: 617 726 2612

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place