Postconditioning in ST-elevation Myocardial Infarction (POSTEMI)
Postconditioning in ST-elevation Myocardial Infarction Treated With Primary PCI
Study objectives: To assess the effects of postconditioning on infarct size in patients with ST-elevation infarction referred to PCI.
Study design: Prospective, randomized, open-label study with blinded endpoint evaluation. Included patients will be randomly allocated to postconditioning or control. Patients with symptoms of acute myocardial infarction of less than 6 hours duration fulfilling ECG criteria for primary PCI are eligible. PCI follow established routines. In postconditioning patients, additional, short (1 min), intermittent balloon occlusions will be applied after initial opening of infarct related artery. After this intervention, PCI proceeds routinely with stent implantation. In the control group, stent implantation after initial opening proceeds as usual. Primary endpoint is final infarct size, determined by MRI after 4 months. 260 patients will be included. Follow-up is 1 year. Inclusion period: 18 - 24 months.
Clinical implications: Reperfusion therapy, administered as early as possible after start of symptoms, has improved the prognosis in acute ST-elevation myocardial infarction. Still, however, many patients suffer large infarctions, subsequently with an increased risk of heart failure, arrhythmias, and death. In pilot studies, mechanical postconditioning has been shown to reduce infarct size and thus potentially improve prognosis. However, the effect of postconditioning must be confirmed in larger clinical trials before implemented in routine treatment.
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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Oslo、ノルウェー、N-0407
- Dept. of Cardiology, Oslo Univ. Hosp. Ulleval
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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:
- acute symptoms consistent with an acute myocardial infarction of less than 6 hours duration
- an occluded infarct related artery must be demonstrated (TIMI-flow 0-1)
Exclusion Criteria:
- Prior myocardial infarction
- Demonstration of collaterals to the infarcted area
- TIMI-flow >1 before intervention or TIMI-flow <2 after initial balloon inflation
- Demonstration of a distal occlusion
- Patients given thrombolytic treatment
- Patients in cardiogenic shock
- Any contraindication to MRI (magnetic resonance imaging)
- Unwillingness 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: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:Postconditioning
Active arm:Postconditioning protocol before routine PCI/stenting of an occluded coronary artery
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After opening of IRA and establishment of TIMI-flow grade 2 or 3, the control group continues the procedure with stenting.
In the postconditioning group 4 additional balloon inflations separated by 1 minute reperfusion are given, starting after 1 minute of reperfusion.
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他の:Control
Control arm: Routine PCI/stenting of an occluded coronary artery without postconditioning
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After opening of IRA and establishment of TIMI-flow grade 2 or 3, the control group continues the procedure with stenting.
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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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Infarct size, assessed by MRI
時間枠:4 months
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4 months
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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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Myocardial blushing grade
時間枠:assessed at the end of PCI procedure
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assessed at the end of PCI procedure
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ST-resolution in ECG
時間枠:Assessed after 1 hour
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Assessed after 1 hour
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Troponin-T and CK-MB
時間枠:peak release values
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peak release values
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Echocardiographic evaluation of left ventricular function including speckle-tracking measurement.
時間枠:assessed at baseline, 4 months and1 year
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Assesment of LV function.
Comparison with CMR in the whole study population and between treatment groups.
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assessed at baseline, 4 months and1 year
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Incidence of treated arrhythmias and heart failure during initial hospitalization Incidence of death, non-fatal myocardial infarction, unstable angina, heart failure, and cerebrovascular disease
時間枠:1-year follow up.
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1-year follow up.
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Myocardial salvage
時間枠:Baseline to 4 months
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Myocardial salvage defined as (area at risk-final infarct size)/area at risk.
Area at risk measured by CMR at baseline and final infarct size by CMR at 4 months.
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Baseline to 4 months
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協力者と研究者
スポンサー
捜査官
- スタディチェア:Jan Eritsland, MD, PhD、Oslo Univ.Hosp. Ulleval
出版物と役立つリンク
一般刊行物
- Tollefsen IM, Shetelig C, Seljeflot I, Eritsland J, Hoffmann P, Andersen GO. High levels of interleukin-6 are associated with final infarct size and adverse clinical events in patients with STEMI. Open Heart. 2021 Dec;8(2):e001869. doi: 10.1136/openhrt-2021-001869.
- Limalanathan S, Andersen GO, Klow NE, Abdelnoor M, Hoffmann P, Eritsland J. Effect of ischemic postconditioning on infarct size in patients with ST-elevation myocardial infarction treated by primary PCI results of the POSTEMI (POstconditioning in ST-Elevation Myocardial Infarction) randomized trial. J Am Heart Assoc. 2014 Apr 23;3(2):e000679. doi: 10.1161/JAHA.113.000679.
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
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