Evaluation of Myocardial Viability : Dual Energy Cardiac CT vs. Cardiac MRI (InfarctusGSI)
Evaluation of Myocardial Viability in Late Presentation Myocardial Infarction: Dual Energy Cardiac CT vs. Cardiac MRI.
The purpose of this study is therefore to show that associated with cardiac angiography echocardiography, in myocardial seen late, would provide the information necessary for the decision revascularization, in a timely manner.
This would allow the patient to avoid duplication of tests including risk related to coronary angiography (bleeding complications, stroke ...) and those related to the implantation of coronary stent (stent) without expected earnings in case of non-viability . This would also reduce the length of hospital stay and costs due to numerous reviews.
調査の概要
詳細な説明
Percutaneous coronary intervention is not recommended in stable patients with late presentation myocardial infarction, and myocardial viability needs to be evaluated before the procedure. The aim of the study is to evaluate the sensibility and specificity of dual-energy CT for the evaluation of myocardial viability in comparison to cardiac MRI.
The experimental procedure is limited to a second CT acquisition performed 10 minutes in dual energy mode.
Sensitivity and Specificity of delayed enhancement >50% of myocardial thickness provided by dual-energy CT will be evaluated in comparison to cardiac MRI.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Normandie
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Rouen、Normandie、フランス、76031
- 募集
- University Hospital of Rouen
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コンタクト：
- Benjamin DUBOURG, Doctor
- 電話番号：+33 2 32 88 64 96
- メール：Benjamin.Dubourg@chu-rouen.fr
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副調査官：
- Jérome CAUDRON, Doctor
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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:
- Man or woman
- Major patient
- Patient with electrical, biological and clinical signs of myocardial infarction, with late presentation (>24 hours)
- Creatinine clearance (calculated using the Cockcroft (<age 65) or MDRD (> 65 years))formula > 30 ml / min.
- Affiliation to the french social security scheme.
- Women of childbearing age: Negative pregnancy test (urine test).
- Postmenopausal women, menopause confirmation of diagnosis
- Patient able to understand the spoken and written French.
- Signature of informed consent
Exclusion Criteria:
- Collapsus or organ failure requiring urgent care in intensive care unit
- Arrhythmia and/or non-reducible tachycardia.
- History of allergic reaction after iodinated contrast medium injection.
- History of nephrogenic systemic fibrosis.
- History of claustrophobia
- Unbalanced asthma.
- Acute pulmonary edema.
- Pregnant or breastfeeding women.
- Clinical signs of thyrotoxicosis.
- Person placed under judicial protection,
- Patient suffering from serious psychiatric disease.
- Patients participating in another clinical trial.
- Contraindication to MRI
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 |
|---|---|
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実験的：second propeller arm scanner
The experimental procedure is to conduct a second helical scanner strictly centered on the heart, 10 minutes after the first helix without inject contrast medium, to assess late enhancement to the inclusion visit.
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The experimental procedure is to conduct a second helical scanner strictly centered on the heart, 10 minutes after the first helix without inject contrast medium, to assess late enhancement.
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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 |
|---|---|---|
|
Number of patient with a possible evaluation of myocardial viability using dual-energy cardiac CT
時間枠：Day 4
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To study the sensitivity of dual-energy cardiac CT for the evaluation of myocardial viability, in patients with late presentation myocardial infarction.
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Day 4
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of patient with a possible evaluation of myocardial viability using cardiac MRI
時間枠：Day 4
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To study the sensitivity of cardiac MRI for the evaluation of myocardial viability in patients with late presentation myocardial infarction.
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Day 4
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協力者と研究者
捜査官
- 主任研究者：Benjamin DUBOURG, Doctor、University Hospital, Rouen
- スタディディレクター：Jean-Nicolas DACHER, Professor、University Hospital, Rouen
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)
研究の完了 (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
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。