MRI as a Predictor of Outcomes in Patients Undergoing Mitral Valve Surgery (MRI-MVS)
Prospective Evaluation of MRI as a Predictor of Outcomes in Patients Undergoing Mitral Valve Surgery: MRI-MVS Study
調査の概要
詳細な説明
Mitral regurgitation is a common disease which can lead to heart failure and death if left untreated. The only known therapy for mitral regurgitation is correction of the mitral valve, most commonly performed by surgical repair or replacement. According the STS database, there were 15,748 lone mitral valve surgeries in 2014. The number of mitral valve surgeries has been increasing with a 23% increase between the years 2010 and 2014. Based on the ACC/AHA guidelines for the management of mitral valve disease, quantifying the severity of mitral regurgitation is central to determining which patients are appropriate for correction of their mitral valve by surgery. Specifically, once the diagnosis of severe MR is made, patients are considered appropriate for mitral valve surgery in almost all clinical circumstances. However, there is a significant mortality and morbidity associated with mitral valve surgery. In the STS database, 30 day mortality was ~2% for repair and ~5% for replacement. This data does not take into account long-term mortality and morbidity from re-operation and life-long anti-coagulation as well as changes in quality of life.
The most common diagnostic tool to assess the severity of MR is echocardiography. Several studies have shown that echocardiography parameters used to quantify and qualify MR have high inter-observer and intra-observer variability, calling the accuracy of these parameters into question. Furthermore, studies have shown that there is a significant degree of discordance between echocardiography and MRI when assessing MR, particularly among patients referred for mitral valve surgery. In a recent study, quantification of mitral regurgitant volume MRI was found to be more accurate than echocardiography in patients who underwent mitral valve surgery. All 38 patients who underwent mitral valve surgery in this study were deemed appropriate according the ACC/AHA guidelines based on echocardiographic findings. However, more than 2/3rds of patients who underwent mitral valve surgery in this study did not have severe MR by MRI. Thus, we propose this prospective multicenter trial to assess: 1) the severity of MR by MRI in patients undergoing mitral valve surgery. 2) the impact of mitral valve surgery on quality of life and healthcare costs in the context of MR severity by MRI, 3) assess patient outcomes post surgery in the context of MR severity by MRI and 4) the likelihood of valve replacement vs. repair according to MR severity by MRI.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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New Jersey
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Morristown、New Jersey、アメリカ、07960
- 募集
- Morristown Medical Center
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コンタクト:
- Seth Uretsky, MD
- 電話番号:973-971-5597
- メール:seth.uretsky@atlantichealth.org
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コンタクト:
- Susan Miller, RN
- 電話番号:9739715597
- メール:susan.miller@atlantichealth.org
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Age 18 years and older.
- Able to give informed consent.
- Undergoing lone mitral valve surgery for chronic primary mitral regurgitation within 30 days.
- Indication for mitral valve surgery is a class I or IIa according to the 2014 ACC/AHA guidelines for the management of valvular heart disease.
Exclusion Criteria:
- Secondary mitral regurgitation.
- Have a device which is not compatible with MRI
- Claustrophobia preventing MRI.
- Concomitant CABG, other valve surgery, or other cardiac surgery.
- Atrial fibrillation or other substantial arrhythmia that would substantially degrade MRI image acquisition.
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Mitral Valve Surgery
Patients undergoing ACC/AHA guideline directed mitral valve surgery for mitral insufficiency.
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ACC/AHA guideline directed mitral valve repair or replacement
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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 |
|---|---|---|
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Operative and peri-operative outcomes according to the mitral regurgitation severity quantified by MRI.
時間枠:2 years
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Operative and peri-operative outcomes (mortality, morbidity, hospitalizations, reoperation, bleeding, and CVA) in the context of mitral regurgitation severity quantified by MRI.
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2 years
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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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Quality of life
時間枠:2 years
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Operative and peri-operative outcomes (mortality, morbidity, hospitalizations, reoperation, bleeding, and CVA) in the context of mitral regurgitation severity quantified by MRI.
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2 years
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Repair vs Replacement
時間枠:4 months
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Assess if the likelihood of mitral valve repair vs. replacement is associated with mitral regurgitant severity as quantified by MRI.
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4 months
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Severity of mitral regurgitation as quantified MRI in subjects who are undergoing guideline directed mitral valve surgery.
時間枠:0 days
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Cross sectional data regarding severity of mitral regurgitation as quantified MRI in subjects who are undergoing guideline directed mitral valve surgery
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0 days
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Correlation of pre-surgical regurgitant volume as quantified by MRI with post-surgical change in LV EDV.
時間枠:4 months
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Correlation of pre-surgical regurgitant volume as quantified by MRI with post-surgical change in LV EDV.
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4 months
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協力者と研究者
スポンサー
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 (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
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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