Intervention in Frailty Versus Usual Care in Frail Patients After an Acute Myocardial Infarction (FRAMIP)
Randomized Comparison Between a Strategy of Intervention in Frailty Versus the Usual Care in Frail Patients After an Acute Myocardial Infarction
Frailty has been associated to a worse outcome in acute coronary syndromes, but the best management of frail patients after an acute coronary syndrome remains unknown. The aim was to investigate the benefit of an intervention on frailty in frail patients after an acute myocardial infarction.
Patients survivors after an acute myocardial infarction (with and without ST-segment elevation), older than 70 years and with pre-frailty (1-2 points) or frailty (≥3 points) according to the Fried's scale measured 24 hours before hospital discharge, will be included. The participants will be randomized to 2 strategies: a) intervention on frailty in addition to the usual care by the cardiologist, and b) conventional strategy consisting only of the usual care by the cardiologist. A multidisciplinary team (physicians, nurses and physiotherapists and nutritionists) will carry out the intervention on frailty The study contemplates a 2-year inclusion period and a 3rd year for the follow-up of the last included patient. The main outcome will be the frailty status (Fried's scale) at 3 months and 1 year. The secondary endpoint will be the clinical events, both cardiovascular and not cardiovascular events, including recurrent events (cumulative events analysis), for the total follow up (3 years in the case of the first included patient). The hypothesis is that an intervention on frailty will improve frailty status and the clinical outcomes in frail patients after an acute myocardial infarction.
調査の概要
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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Valencia、スペイン、46010
- Juan Sanchis
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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:
- Admission for acute myocardial infarction and survivors in the hospitalization phase
- Age =>70 years
- Prefrail or frail status (Fried scale =>1 points)
Exclusion Criteria:
- Cognitive impairment (Pfeiffer test)
- Severe concomitant disease that could hamper the participation in the study
- Patient refusal to participate
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：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：Intervention on frailty
Intervention on frailty in addition to the usual care by the cardiologist.
A multidisciplinary team (physicians, nurses and physiotherapists and nutritionists) will carry out the intervention on frailty
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Multidisciplinary team (physicians, nurses, physiotherapists, and nutritionists):
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介入なし：Control
Conventional strategy consisting only of the usual care by the cardiologist
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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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Change on frailty status according to the Fried scale
時間枠：3 months and 1 year
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Points in the Fried scale
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3 months and 1 year
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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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Total cardiac (cardiac death, reinfarction, postdischarge revascularization, readmission for acute heart failure, readmission for other cardiac cause) and non-cardiac (all-cause mortality or readmission for non-cardiac cause) clinical events
時間枠：Up to 3 years
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Number of participants with the events
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Up to 3 years
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All-cause mortality
時間枠：Up to 3 years
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Number of participants dead
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Up to 3 years
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Ischemic events (reinfarction or postdischarge revascularization)
時間枠：Up to 3 years
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Number of participants with reinfarction (readmission for chest pain with troponin elevation) or postdischarge revascularization (percutaneous coronary intervention or coronary surgery)
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Up to 3 years
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Readmission for acute heart failure
時間枠：Up to 3 years
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Number of participants with readmission for acute heart failure
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Up to 3 years
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Readmission for non-cardiac causes
時間枠：Up to 3 years
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Number of participants with readmission for non-cardiac cause
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Up to 3 years
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Change of Quality of life (EUROQOL)
時間枠：3 months and 1 year
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EUROQOL test
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3 months and 1 year
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Change of Functional capacity (walk distance test)
時間枠：3 months and 1 year
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Distance walked during 6 minutes
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3 months and 1 year
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Change of Nutritional status (Mini Nutritional Assessment)
時間枠：3 months and 1 year
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Mini Nutritional Assessment Test
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3 months and 1 year
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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Sanchis J, Nunez E, Ruiz V, Bonanad C, Fernandez J, Cauli O, Garcia-Blas S, Mainar L, Valero E, Rodriguez-Borja E, Chorro FJ, Hermenegildo C, Nunez J. Usefulness of Clinical Data and Biomarkers for the Identification of Frailty After Acute Coronary Syndromes. Can J Cardiol. 2015 Dec;31(12):1462-8. doi: 10.1016/j.cjca.2015.07.737. Epub 2015 Aug 21.
- Sanchis J, Bonanad C, Ruiz V, Fernandez J, Garcia-Blas S, Mainar L, Ventura S, Rodriguez-Borja E, Chorro FJ, Hermenegildo C, Bertomeu-Gonzalez V, Nunez E, Nunez J. Frailty and other geriatric conditions for risk stratification of older patients with acute coronary syndrome. Am Heart J. 2014 Nov;168(5):784-91. doi: 10.1016/j.ahj.2014.07.022. Epub 2014 Jul 30.
- Sanchis J, Sastre C, Ruescas A, Ruiz V, Valero E, Bonanad C, Garcia-Blas S, Fernandez-Cisnal A, Gonzalez J, Minana G, Nunez J. Randomized Comparison of Exercise Intervention Versus Usual Care in Older Adult Patients with Frailty After Acute Myocardial Infarction. Am J Med. 2021 Mar;134(3):383-390.e2. doi: 10.1016/j.amjmed.2020.09.019. Epub 2020 Oct 24.
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。
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