Correlation Study of Imaging Data Acquired During CABG With Data Acquired in the Cath Lab (PERSEUS)
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:
- 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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
North Carolina
-
Greenville、North Carolina、アメリカ、27834
- East Carolina Heart Institute at Vidant Medical Center
-
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:診断
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
他の:Patients referred for CABG
|
Intracoronary pressure and flow measurements
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
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Correlation Analysis
時間枠:18 months
|
Correlation between anatomy, functional anatomy, FFR, SPY® RMP change, and the presence or absence of imaged competitive flow
|
18 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Correlation Analysis
時間枠:18 months
|
Correlation analysis between anatomy, functional anatomy, FFR, CFR, HMR and SPY® perfusion data for each TVECA and perfusion territory.
|
18 months
|
Instantaneous Wave Free Ratio (iFR)
時間枠: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
|
18 months
|
Wave Intensity Analysis (WIA)
時間枠: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
|
18 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Ashesh N Buch, MBChB, MD、East Carolina University
- 主任研究者:T. Bruce Ferguson, MD、East Carolina University
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- UMCIRB 13-001949
- PERSEUS I (その他の助成金/資金番号:Volcano Corporation 120313)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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