Polish Multicenter PERTs PE Outcomes Registry (PolPERTs)
Polish Multicenter Pulmonary Embolism Response Teams Outcomes Registry
調査の概要
状態
条件
詳細な説明
Pulmonary embolism (PE) is the third leading cause of cardiovascular mortality. The presentation of PE may vary from asymptomatic or mild exertion disturbances (low-risk PE) treated with anticoagulants only to hemodynamic "obstructive" collapse and death (high-risk PE). Patient outcome depends on ability of the right ventricle to sustain the increased afterload caused by the embolic burden. Careful risk stratification is crucial, and the Pulmonary Embolism Response Team (PERT) concept offers a rapid and multidisciplinary approach focused on improving outcomes for patients with PE by advancing its recognition, diagnosis, and treatment. All institutionalized PERTs in Poland have been invited to join the study. The data is administrated by the Poznan University of Medical Sciences on the basis of an agreement between the PERT centres.
The goal of this registry is to describe current practice and outcomes in patients with acute PE guided by Polish PERTs. The primary data recorded include details of each patient's clinical status, co-morbidities, the administered treatment modalities, the results of additional studies (ab tests results, ECG, imaging studies), and the outcome.
The data collection will have no impact on the way the patient is diagnosed and treated.The study endpoints comprise respiratory failure, shock, death distal systemic embolization (i.e. stroke) and major or minor bleeding complications classified according to the International Society on Thrombosis and Haemostasis classification.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前：Aleksander Araszkiewicz
- 電話番号：+48 8549146
- メール：aaraszkiewicz@ump.edu.pl
研究連絡先のバックアップ
- 名前：Sylwia Sławek-Szmyt
- 電話番号：+48 8549293
- メール：sylwia.slawek@skpp.edu.pl
研究場所
-
-
GreaterPoland
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Poznań、GreaterPoland、ポーランド、61-848
- 募集
- Poznan University of Medical Sciences
-
コンタクト：
- Aleksander Araszkiewicz, Prof.
- 電話番号：+48 8549149
- メール：aaraszkiewicz@ump.edu.pl
-
コンタクト：
- Sylwia Sławek-Szmyt, MD, PhD
- メール：sylwia.slawek@skpp.edu.pl
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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:
- PE confirmed by computed tomography pulmonary angiography.
- PE symptoms duration ≤ 14 days.
High-risk PE with hemodynamic instability (one of):
- cardiac arrest
- obstructive shock
- persistent hypotension.
- Intermediate-high risk PE patients with right ventricle dysfunction confirmed by imaging studies and elevated troponin level.
Exclusion Criteria:
1. Refusal to sign the informed consent form.
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 |
|---|
|
Intermediate-high risk PE
Confirmed PE causing right ventricle dysfunction confirmed by computed tomography pulmonary angiography or transthoracic echocardiography and elevated troponin level
|
|
High-risk PE
Confirmed PE causing hemodynamic instability:
|
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 |
|---|---|---|
|
Clinical improvement during hospitalization
時間枠：24 hours after specific PE treatment implementation
|
Incidence of arterial blood saturation increase >92%
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24 hours after specific PE treatment implementation
|
|
Ventricular strain reduction
時間枠：24 hours after specific PE treatment implementation
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Rate of right ventricular strain reduction (right ventricle/left ventricle ratio assessment) in echocardiography
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24 hours after specific PE treatment implementation
|
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Early mortality rate from pulmonary embolism
時間枠：Two weeks since PE diagnosis
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Number of patients who died from pulmonary embolism (right heart failure)
|
Two weeks since PE diagnosis
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Total mortality rate from pulmonary embolism
時間枠：3 months since PE diagnosis
|
Number of patients who died from pulmonary embolism (right heart failure)
|
3 months since PE diagnosis
|
|
Bleeding events incidence
時間枠：3 months since PE diagnosis
|
Incidence of major bleedings assessed using ISTH criteria
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3 months since PE diagnosis
|
協力者と研究者
捜査官
- 主任研究者：Aleksander Araszkiewicz, Prof.、Poznan University of Medical Sciences
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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。