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NCT02138305 · ClinicalTrials.gov registry record · NA
Correlation Study of Imaging Data Acquired During CABG With Data Acquired in the Cath Lab
A NA study, sponsored by East Carolina University.
- Completed
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT02138305 is a NA study that has completed, run by East Carolina University. The registered enrollment target is 1 participants.
The verdict
NCT02138305, a NA study, has completed, sponsored by East Carolina University.
- COMPLETED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
Study 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 duri
Interventions
- DEVICE ComboMap XT Guidewire
- PROCEDURE 'SPY' NIRF During CABG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2014-12 |
| Est. Completion | 2019-03-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02138305
The ClinicalTrials.gov registry entry for NCT02138305 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is East Carolina University, which has 58 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ComboMap XT Guidewire is the first listed.
NCT02138305 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02138305 about?
NCT02138305 is a clinical study titled "Correlation Study of Imaging Data Acquired During CABG With Data Acquired in the Cath Lab". 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 si...
What is the current status of trial NCT02138305?
This trial is currently completed. It is a NA study. The enrollment target is 1 participants. The study started on 2014-12. Estimated completion is 2019-03-30.
What interventions are being tested in trial NCT02138305?
The interventions under investigation include: ComboMap XT Guidewire (DEVICE), 'SPY' NIRF During CABG (PROCEDURE).
Who is sponsoring clinical trial NCT02138305?
This trial is sponsored by East Carolina University, which has 58 total clinical trials registered on ClinicalTrials.gov.
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