A Novel Automated & Comprehensive Approach for Ventricular Function Assessment in Heart Failure
Curvedness-based Imaging: A Novel Automated & Comprehensive Approach for Ventricular Function Assessment in Heart Failure
調査の概要
詳細な説明
Heart failure imposes major global health care burden on society and suffering for the individual.In the US, HF affects 5.7 million patients, and is the leading cause of hospitalization for people over 65 years, with 25% to 50% rate or hospital readmission within 6 months.In Singapore, between 1991 and 1998, it accounted for 4.5% of all hospital admissions and 2.5% of mortality in the geriatric age group.It confers an annual mortality of 10%.
The early diagnosis and identification of the underlying etiology of HF is of paramount importance; some causes require specific treatment and may be correctable. From updated American College of Cardiology/American Heart Association guidelines, some questions must be addressed for suspected HF patients: Is the left ventricular ejection fraction preserved or reduced? Is the structure of the LV normal or abnormal? Are there other structural abnormalities such as right ventricular (RV) abnormalities that could account for the clinical presentation? Is there LV global and regional dysfunction and to what extent? Is the etiology ischemic or non-ischemic?
Cardiac imaging is important both for HF diagnosis and monitoring of progress. Impaired pump function, expressed reduced left ventricular ejection fraction is often used as a marker of HF. About 50% of HF have preserved EF.In this situation, more intricate and comprehensive imaging involving measurement of multiple diastolic and systolic parameters, usually using echocardiography, may become necessary to address the questions mentioned above.
Our solution is expected to result in a significant cost saving for HF patients. HF diagnosis is still very challenging, consisting of assessment of medical and family histories, a physical exam and diagnostic imaging tests. The investigators compare the cost difference in traditional way against our proposed solution. The traditional diagnostic tests include chest x-ray, BNP blood test, echocardiography, nuclear heart scan and cardiac catheterization. In this project, the investigators estimate the cost of echocardiography, nuclear heart scan and cardiac catheterization for HF diagnosis. Based on clinical experience, among 1000 patients undergoing echocardiography, 50% will be referred to nuclear heart scan and 30% will be referred to invasive cardiac catheterization. The cost of the whole workup is estimated to be $1.95 million. If 1000 patients undergo our proposed CBI solution directly, the cost estimated at $1.4 million. The cost saving is estimated at S$400 per patient.
Hence, the investigators will be exploring the following for this study:
Primary aim: Assess LV systolic and diastolic function from curvedness-based imaging in 120 HF patients with reduced ejection fraction and normal ejection fraction.
Secondary aim: Evaluate the utility of curvedness-based imaging for the diagnosis of etiology of HF, against gold standard gadolinium enhanced CMR in subgroup of HF patients.
Exploratory aim: Evaluate the utility of curvedness-based imaging for the prediction of prognosis during 6 month follow up, where clinical outcome include death, CV death and HF re-admission.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Singapore、シンガポール、169609
- National Heart Centre Singapore
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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:
- Patients presented to hospital with a primary diagnosis of Heart Failure or are attending a hospital clinic for management of Heart Failure within 6 months of an episode of decompensated heart failure, which either resulted in a hospital admission (primary diagnosis) or was treated in out-patient clinic.
- Written informed consent obtained
Exclusion Criteria:
- Aged < 21 years
- Contraindication to CMR examination.
- Cardiac pacemaker
- Brain aneurysm or clips
- Electronic implants or prosthesis
- Eye metal foreign body injury
- Severe claustrophobia
- Severe renal impairment, glomerular filtration rate < 30ml/min/1.73m2
- Non-cardiac illness with life expectancy of less than 2 years
- Previous heart, kidney, liver or lung transplantation.
- HF primary due to severe valve disease
- Other specific subgroups of HF: Including constrictive pericarditis, complex adult congenital heart disease, hypertrophic cardiomyopathy, eosinophilic myocarditis, cardiac amyloid and acute chemotherapy-induced cardiomyopathy.
- Isolated right heart failure. Combined right and left heart failure will be included; Secondary to severe lung disease or pulmonary hypertension.
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
- 観測モデル:コホート
- 時間の展望:見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
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Heart Failure
Patients presented to hospital with a primary diagnosis of Heart Failure or are attending a hospital clinic for management of Heart Failure within 6 months of an episode of decompensated heart failure, which either resulted in a hospital admission (primary diagnosis) or was treated in out-patient clinic. Cardiovascular Magnetic Resonance and Echocardiogram will be performed. |
左心室の容積、機能、質量の評価用。
これは、遅延強調画像技術に基づいた心筋線維症の評価にも使用されます。
拡張期機能と収縮期機能、および弁膜機能と心臓機能の評価用。
心室と動脈の結合も行われます。
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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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Allergic reaction due to MRI contrast
時間枠:Within first day of scan
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Within first day of scan
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協力者と研究者
捜査官
- 主任研究者:Ru San Tan, MD、National Heart Centre Singapore
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
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。
心不全の臨床試験
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Novartis Pharmaceuticals完了EC-MPS による治療に関心があり、コア研究の 12 か月の治療期間を無事に完了した患者 (de novo Heart Recipients)
心血管磁気共鳴の臨床試験
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Germans Trias i Pujol Hospital完了虚血性脳卒中 | 磁気共鳴画像 | 動脈閉塞 | CTSスペイン
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Johns Hopkins UniversityUniversity of Texas at Austin; Baszucki Brain Research Fund; Magnus Medical完了
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Ospedale della Misericordiaわからない