Computed Tomography Coronary Angiography Before Stent Implantation
Role of Computed Tomography Coronary Angiography in Optimalization of Percutaneous Coronary Interventions With Stent Implantation.
調査の概要
詳細な説明
Currently most percutaneous coronary interventions (PCI) are planned and performed on the basis of invasive coronary angiography which provides the information that is confined to the vessel lumen. This limitation may be partially responsible for the unfavorable long term outcome and complications that occur in some patients. Additional information on the disease burden in angiographically normal coronary segments adjacent to the lesion site could impact the treatment strategy and clinical results. Imaging modalities that allow not only lumen but also vessel wall assessment include both invasive (e.g. intravascular ultrasounds - IVUS) and non-invasive (e.g. multislice computed tomography - MSCT) methods. IVUS guidance of the coronary interventions is expensive and given its invasiveness is related to the additional risk. The number of patients who are referred for coronary angiography with significant stenosis diagnosed with MSCT is rapidly increasing. Most interventional cardiologists are not familiar with coronary vessel images produced by MSCT. The aim of our study is to assess if the analyses of MSCT images before the PCI may impact the treatment strategy and immediate results. The study will enroll subjects with significant coronary stenosis diagnosed with MSCT who are referred to the catheterisation laboratory for invasive angiography and PCI. The study participants will be randomized into two groups:
Group 1 - the results of MSCT are analysed by the interventional cardiologist that is to perform angiography and PCI. Based on this analysis preliminary procedural strategy is planned (stent diameters, decision on direct stenting vs. predilatation, decision on postdilation) Group 2 - interventional cardiologist is blinded to the images obtained by MSCT. The PCI procedure is performed solely on the basis of invasive coronary angiography In both study groups IVUS will be performed before and after stent implantation. The operator will be blinded to the results of pre-PCI IVUS. The second IVUS will be performed when angiographic results are optimal in the opinion of the operator. The results of the second IVUS examination will be the efficacy measure of the two compared treatment strategies.
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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Warsaw、ポーランド、04-628
- Institute of Cardiology
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
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:
- Stable coronary artery disease
- Planned stent implantation into single lesion in native coronary artery
- Planned stent diameter: 2.5-4.0 mm
Exclusion Criteria:
- Women younger than 50 years
- Lesion location in left main coronary artery
- Atrial fibrilation or other significant arrythmia
- Severe chronic obturatory pulmonary disease
- Hyperthyroidism
- Known allergy to contrast media
- Glomerular filtration rate < 30
- Treatment of bifurcation lesion
- Stent implantation for in-stent restenosis
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: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 |
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実験的:CT
Procedure of stent implantation will be planed on the basis of both angiography and computed tomography results.
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The results of the CT scan will be analysed by the interventional cardiologist that is to perform angiography and PCI.
Based on this analysis preliminary procedural strategy is planned (stent diameters, decision on direct stenting vs. predilatation, decision on postdilation)
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アクティブコンパレータ:Angio
Procedure of stent implantation will be planned only on the basis of diagnostic coronary angiography.
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Interventional cardiologist will be blinded to the images obtained by CT.
The PCI procedure will be planned and performed solely on the basis of invasive coronary angiography
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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 |
時間枠 |
|---|---|
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Minimal in stent lumen area as assessed by IVUS
時間枠:Up to 10 minutes after stent implantation
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Up to 10 minutes after stent implantation
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Adequacy of lesion coverage defined as minimal lumen area in reference segments adjacent to stent shoulder.
時間枠:Up to 10 minutes after stent implantation
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Up to 10 minutes after stent implantation
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Mean stent lumen area
時間枠:Up to 10 minutes after stent implantation
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Up to 10 minutes after stent implantation
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Mean lumen area and plaque and media area in 10mm segments adjucent to stent edges.
時間枠:Up to 10 minutes after stent implantation
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Up to 10 minutes after stent implantation
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Qualitative and quantitative assessment of potential complications (tissue prolaps, plaque shift, stent edge dissection and stent malapossition)
時間枠:Up to 10 minutes after stent implantation
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Up to 10 minutes after stent implantation
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協力者と研究者
捜査官
- 主任研究者:Jerzy Pregowski, MD、Institute of Cardiology, Warsaw, Poland
出版物と役立つリンク
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 (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
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。