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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: ComboMap XT Guidewire Procedure: 'SPY' NIRF During CABG Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Controlled prospective observational study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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)
Study Start Date : December 2014
Actual Primary Completion Date : March 30, 2018
Actual Study Completion Date : March 30, 2019

Arm Intervention/treatment
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
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




Primary Outcome Measures :
  1. Correlation Analysis [ Time Frame: 18 months ]
    Correlation between anatomy, functional anatomy, FFR, SPY® RMP change, and the presence or absence of imaged competitive flow


Other Outcome Measures:
  1. 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.

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138305


Locations
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United States, North Carolina
East Carolina Heart Institute at Vidant Medical Center
Greenville, North Carolina, United States, 27834
Sponsors and Collaborators
East Carolina University
Volcano Corporation
Imperial College London
Investigators
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Principal Investigator: Ashesh N Buch, MBChB, MD East Carolina University
Principal Investigator: T. Bruce Ferguson, MD East Carolina University
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Responsible Party: Dr Ashesh N. Buch, Assistant Professor Cardiovascular Sciences (Interventional Cardiology), East Carolina University
ClinicalTrials.gov Identifier: NCT02138305    
Other Study ID Numbers: UMCIRB 13-001949
PERSEUS I ( Other Grant/Funding Number: Volcano Corporation 120313 )
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Dr Ashesh N. Buch, East Carolina University:
Fractional Flow Reserve (FFR)
Instantaneous Wave Free Ratio (iFR)
Coronary Flow Reserve (CFR)
Hyperemic Stenosis Resistance Index (HSR)
Hyperemic microvascular resistance (HMR)
Wave intensity analysis (WIA)
Myocardial Perfusion
SPY NIRF Regional Myocardial Perfusion Analysis
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases