Coronary Artery DiseasePERSEUSNCT02138305
Correlation Study of Imaging Data Acquired During CABG With Data Acquired in the Cath Lab
A study testing ComboMap XT Guidewire and 'SPY' NIRF During CABG in people with Coronary Artery Disease, run by East Carolina University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- ComboMap XT Guidewire and 'SPY' NIRF During CABG
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 30 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
East Carolina Heart Institute at Vidant Medical Center
Greenville, North Carolina, 27834
About this study
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)
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.
Read more
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:
- 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.
- 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
- Being tested
- ComboMap XT Guidewire, 'SPY' NIRF During CABG
- 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
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ComboMap XT GuidewireDevice
Intracoronary pressure and flow measurements
'SPY' NIRF During CABGProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: ComboMap XT Guidewire; Procedure: 'SPY' NIRF During CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Analysis
Correlation between anatomy, functional anatomy, FFR, SPY® RMP change, and the presence or absence of imaged competitive flow
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startDec 2014
- Primary completion30 Mar 2018
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Controlled prospective observational study
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Collaborators
- Volcano Corporation, Imperial College London
- Responsible party
- Principal investigator, Dr Ashesh N. Buch, East Carolina University
- Investigators
- Ashesh N Buch, MBChB, MD, Principal investigator, East Carolina UniversityT. Bruce Ferguson, MD, Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138305
- Sponsor's protocol ID
- UMCIRB 13-001949
- Other IDs
- PERSEUS I
- Acronym
- PERSEUS
- Status last verified
- Aug 2019
- First submitted
- 12 May 2014
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02138305
- Acronym / sponsor ID
- PERSEUS / UMCIRB 13-001949
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Collaborators
- Volcano Corporation, Imperial College London
- Study start
- Dec 2014
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 14 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Controlled prospective observational study
| Arm | Type | Receives |
|---|---|---|
| Patients referred for CABG | Other | Device: ComboMap XT Guidewire, Procedure: 'SPY' NIRF During CABG* Patients who after undergoing standard of care diagnostic coronary angiography will be referred for CABG * ComboMap XT Guidewire * 'SPY' NIRF During CABG |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ComboMap XT GuidewireIntracoronary pressure and flow measurements | Device | Patients referred for CABG |
| 'SPY' NIRF During CABGFDA 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 | Procedure or surgery | Patients referred for CABG |
Primary outcome
Correlation Analysis
Time frame: 18 months
Correlation between anatomy, functional anatomy, FFR, SPY® RMP change, and the presence or absence of imaged competitive flow
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashesh N Buch, MBChB, MD principal investigator
East Carolina University
T. Bruce Ferguson, MD principal investigator
East Carolina University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ComboMap XT Guidewire and 'SPY' NIRF During CABG in people with Coronary Artery Disease, run by East Carolina University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Analysis (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.