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Correlation Study of Imaging Data Acquired During CABG With Data Acquired in the Cath Lab (PERSEUS)

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ClinicalTrials.gov Identifier: NCT02138305
Recruitment Status : Completed
First Posted : May 14, 2014
Last Update Posted : August 28, 2019
Sponsor:
Collaborators:
Volcano Corporation
Imperial College London
Information provided by (Responsible Party):
Dr Ashesh N. Buch, East Carolina University

Tracking Information
First Submitted Date  ICMJE May 12, 2014
First Posted Date  ICMJE May 14, 2014
Last Update Posted Date August 28, 2019
Study Start Date  ICMJE December 2014
Actual Primary Completion Date March 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2014)
Correlation Analysis [ Time Frame: 18 months ]
Correlation between anatomy, functional anatomy, FFR, SPY® RMP change, and the presence or absence of imaged competitive flow
Original Primary Outcome Measures  ICMJE
 (submitted: May 12, 2014)
Correlation Analysis [ Time Frame: 18 months ]
  1. Correlation between anatomy, functional anatomy, FFR, SPY® RMP change, and the presence or absence of imaged competitive flow.
  2. Correlation analysis between anatomy, functional anatomy, FFR, CFR, HMR and SPY® perfusion data for each target vessel epicardial coronary artery stenosis (TVECA) regional myocardial perfusion territory
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2014)
  • Instantaneous Wave Free Ratio (iFR) [ Time Frame: 18 months ]
    Offline analysis of de-identified encrypted data from the Combo wire study by Dr Justin Davies's research group, Imperial College, London for iFR determination
  • Wave Intensity Analysis (WIA) [ Time Frame: 18 months ]
    Offline WIA analysis of de-identified encrypted data from the Combo wire study by Dr Justin Davies's research group, Imperial College, London
Current Other Pre-specified Outcome Measures
 (submitted: May 13, 2014)
  • Correlation Analysis [ Time Frame: 18 months ]
    Correlation analysis between anatomy, functional anatomy, FFR, CFR, HMR and SPY® perfusion data for each TVECA and perfusion territory.
  • Instantaneous Wave Free Ratio (iFR) [ Time Frame: 18 months ]
    Offline analysis of de-identified encrypted data for each TVECA interrogated with ComboMap XT wire by Dr Justin Davies's research group, Imperial College, London for iFR determination. Correlation analysis between iFR and presence or absence of imaged competitive flow and intra-operative RMP data on SPY® NIRF
  • Wave Intensity Analysis (WIA) [ Time Frame: 18 months ]
    Offline wave wave intensity analysis (WIA) of de-identified encrypted data for each TVECA interrogated with ComboMap XT wire by Dr Justin Davies's research group, Imperial College, London. Correlation analysis between WIA data and presence or absence of imaged competitive flow and intra-operative RMP data on SPY® NIRF
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Correlation Study of Imaging Data Acquired During CABG With Data Acquired in the Cath Lab
Official Title  ICMJE Collaborative Pilot Study to Determine the Correlation Between Intra-Operative Observations Using SPY® Near Infra-Red Imaging and Cardiac Catheterization Laboratory Physiological Assessment of Lesion Severity (PERSEUS Pilot Study)
Brief Summary

Visual assessment of a coronary artery narrowing (called stenosis) seen on angiography is conventionally used to infer how likely the stenosis will limit blood flow (called ischemia) under conditions of increased demand (e.g exercise). This is based on animal work and data from humans with simple single vessel disease with no co-existing conditions. These data have been extrapolated to more complex patients/ complex disease but clearly over-simplifies the situation in the majority of patients cardiologists treat.

Pivotal work by DeBruyne, Pils and colleagues in the 90's convincingly showed that pressure derived measurements, called FFR, from the coronary artery during a cardiac catheterization, more accurately identify stenoses that would cause ischemia compared to visual assessment alone. A strategy of FFR guided coronary stenting with drug eluting stents significantly improved outcomes and reduced costs compared to visual assessment alone (FAME trial). Deferring treatment based on FFR has been shown to be safe (DEFER Trial). FFR has excellent sensitivity and specificity. A FFR of <=0.80 was used as this identified ischemia causing lesions 90% of the time. Therefore, the concept of FFR guided percutaneous revascularisation and treatment deferral has a robust evidence base to support it.

Coronary bypass grafting (CABG) is traditionally based solely on a visual assessment of angiography images. SPY® Infrared Fluorescence Angiography (NIRF, FDA approved 2005) is used by some cardiac surgeons to assess the patency of bypass grafts in real-time in the operating room, as a surrogate for immediate traditional coronary angiography. Dr. Ferguson observed that regional myocardial perfusion (RMP) image data was also captured in these video sequences.

Study Hypotheses:

  1. In patients who are likely CABG candidates, target vessel epicardial coronary arteries (TVECAs) with FFR > 0.80 will not demonstrate an increase in RMP despite an anatomically patent bypass conduit during SPY® imaging.
  2. In TVECAs with an increase in RMP during SPY® imaging, cardiac catheter laboratory measures of coronary physiology from that TVECA, namely one or a combination of FFR, CFR, HSR and HMR, will correlate with the SPY® data on myocardial perfusion, and suggest a potential mechanism for this physiologic response to TVECA grafting.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Controlled prospective observational study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Device: ComboMap XT Guidewire
    Intracoronary pressure and flow measurements
  • Procedure: 'SPY' NIRF During CABG
    FDA approved use of injection of indocyanine green for the purposes of performing pre and post coronary grafting graft patency and perfusion assessment with the SPY near infra red fluorescence system
Study Arms  ICMJE Patients referred for CABG
  • Patients who after undergoing standard of care diagnostic coronary angiography will be referred for CABG
  • ComboMap XT Guidewire
  • 'SPY' NIRF During CABG
Interventions:
  • Device: ComboMap XT Guidewire
  • Procedure: 'SPY' NIRF During CABG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 26, 2018)
1
Original Estimated Enrollment  ICMJE
 (submitted: May 12, 2014)
30
Actual Study Completion Date  ICMJE March 30, 2019
Actual Primary Completion Date March 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age >18<80
  • Patients with stable angina or NSTEMI with total CK rise of <1000 U/litre who after planned coronary angiography are going to be referred for CABG and have at least one vessel with a visual 40-80% stenosis that is interrogated with intracoronary physiology

Exclusion Criteria:

  • Emergent status, or Cardiogenic shock
  • LVEF <40%
  • History of actively malignant disease
  • Patient needing concomitant valvular surgery or other cardiac structural reconstructive surgery
  • As is standard of care, those vessels that are extremely tortuous, very small caliber and/or heavily calcified would not have such wires passed down them. Furthermore, those vessels that are 80-90+% stenosed, with <TIMI 3 flow, which we would not normally pass a diagnostic physiology pressure wire, would not be studied with ComboXT wire.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02138305
Other Study ID Numbers  ICMJE UMCIRB 13-001949
PERSEUS I ( Other Grant/Funding Number: Volcano Corporation 120313 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Ashesh N. Buch, East Carolina University
Study Sponsor  ICMJE East Carolina University
Collaborators  ICMJE
  • Volcano Corporation
  • Imperial College London
Investigators  ICMJE
Principal Investigator: Ashesh N Buch, MBChB, MD East Carolina University
Principal Investigator: T. Bruce Ferguson, MD East Carolina University
PRS Account East Carolina University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP