Impact of Vascular Reparative Therapy on Vasomotor Function and Myocardial Perfusion:a Randomized H215O PET/CT Study (VANISH)
Impact of Vascular Reparative Therapy on Vasomotor Function and Myocardial Perfusion: a Randomized H215O PET/CT Study
調査の概要
詳細な説明
Objective The objective of the proposed study is to determine the impact of VRT, in comparison with conventional drug-eluting stenting, on endothelium dependent vasodilation and maximal hyperemic myocardial perfusion using H215O PET.
Study design The study is designed as a single center single-blind randomized clinical trial and will be conducted at the VU University Medical Center in Amsterdam.
Summary of the study design It is hypothesized that VRT will result in augmented endothelium dependent coronary vasodilation and maximal myocardial perfusion as compared with conventional stenting of a coronary lesion. Within one year sixty patients (age 18-65) with documented single vessel CAD (type A or B1 lesion) accepted for PCI based on clinical grounds and according to current international guidelines, will be asked to participate in this trial. Patients will be randomized to implantation of a drug-eluted stent (Xience Prime) or BRS (Absorb). The patients will be blinded to the nature of the implanted device. H2 15O PET will be performed one month (reference scan), one year, and three years after the PCI procedure (resolution of BRS is generally complete within a three year period). The PET protocol will consist of three MBF measurements: resting MBF, during endothelial dependent vasodilation provoked by coldpressor-testing (CPT), and during (endothelial dependent and independent) maximal vasodilation by infusion of adenosine intravenously. After three years a control invasive coronary angiogram will document any potential obstructive coronary lesions that may affect the MBF measurements.
Primary study parameters/outcome of the study MBF measurements: resting MBF, during endothelial dependent vasodilation provoked by cold-pressor-testing (CPT), and during (endothelial dependent and independent) maximal vasodilation by infusion of adenosine intravenously
Secondary study parameters/outcome of the study Obstructive coronary lesions on control invasive coronary angiogram that may affect the MBF measurements.
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
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-
Noord-Holland
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Amsterdam、Noord-Holland、オランダ、1081 HV
- VU University 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:
- Patients with documented obstructive CAD by invasive coronary angiography resulting in myocardial ischemia (either documented by invasive (i.e. fractional flow reserve, FFR) or noninvasive imaging techniques (e.g. exercise ECG, myocardial perfusion imaging, or inducibility of wall motion abnormalities during dobutamine stress).
- Presence of a single, de-novo lesion in a native coronary artery (type A or B1), with a reference vessel diameter of at least 3.0 mm and a diameter stenosis of 50% or more and less than 100%, with a thrombolysis in myocardial infarction (TIMI) flow grade of at least 2. Coronary lesion must be amendable for successful treatment with one of the following BRS device dimensions: length 18 or 28 mm, diameter 3.0 or 3.5 mm.
Exclusion Criteria:
- age of 65 or above
- refusal or inability to provide written informed consent
- other than single CAD
- abnormal echocardiographic findings (i.e. wall motion abnormalities, ventricular hypertrophy, valvular disease etc.)
- complex coronary lesion characteristics (e.g. lesions located in the left main coronary artery, lesions involving a side branch more than 2 mm in diameter, and the presence of thrombus or another clinically significant stenosis in the target vessel)
- poor kidney function defined as an eGFR < 30 ml/min
- astma or chronic obstructive pulmonary disease
- other than sinus rhythm
- pregnancy
- bail out stenting after placement of the study device
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Bioresorbable vascular scaffold
Paritcipants will receive a bioresorbable vascular scaffols (BVS)
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Drug eluting coronary stent, resorbable in 2-3 years
|
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アクティブコンパレータ：Xience Prime
Participant will receive a Xience Prime stent
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Drug eluting metallic stent
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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 |
|---|---|---|
|
Evaluation of Myocardial Blood Flow over time
時間枠：Three years
|
Endothelial dependent vasomotor function and effect on myocardial perfusion
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Three years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Restenosis
時間枠：Three years
|
Obstructive coronary lesions and lumen dimensions on control invasive coronary angiogram that may affect the MBF measurements
|
Three years
|
協力者と研究者
捜査官
- 主任研究者：Paul Knaapen, MD, PhD、Amsterdam Umc, Location Vumc
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
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 (見積もり)
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
その他の研究ID番号
- VANISH
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