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

NCT02138305 | Completed FDA Device

• 2 other identifiers: UMCIRB 13-001949PERSEUS I
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Correlation Analysis

  Correlation between anatomy, functional anatomy, FFR, SPY® RMP change, and the presence or absence of imaged competitive flow

  18 months

Other Outcomes (3)

• Correlation Analysis

  18 months

• Instantaneous Wave Free Ratio (iFR)

  18 months

• Wave Intensity Analysis (WIA)

  18 months

Study Arms (1)

Patients referred for CABG

OTHER

* 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; Procedure: 'SPY' NIRF During CABG

Interventions

ComboMap XT Guidewire DEVICE

Intracoronary pressure and flow measurements

Patients referred for CABG

'SPY' NIRF During CABG PROCEDURE

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

Patients referred for CABG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• East Carolina University: lead
• Volcano Corporation: collaborator
• Imperial College London: collaborator

Study Sites (1)

East Carolina Heart Institute at Vidant Medical Center

Greenville, North Carolina, 27834, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Ashesh N Buch, MBChB, MD

  East Carolina University

  PRINCIPAL INVESTIGATOR

• T. Bruce Ferguson, MD

  East Carolina University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Cardiovascular Sciences (Interventional Cardiology)

Model Details: Controlled prospective observational study

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: May 14, 2014
• Study Start: December 1, 2014
• Primary Completion: March 30, 2018
• Study Completion: March 30, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

US (1)