Correlation Study of Imaging Data Acquired During CABG With Data Acquired in the Cath Lab
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 6/1/2018 |
| Start Date: | December 2014 |
| End Date: | March 30, 2018 |
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)
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.
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.
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
wire.
We found this trial at
1
site
526 Moye Boulevard
Greenville, North Carolina 27834
Greenville, North Carolina 27834
Principal Investigator: Ashesh N Buch, MBChB, MD
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