Screening for Atrial Fibrillation in Pulmonary Embolism Study -SAFE-PE Study (SAFE-PE)
Screening for Atrial Fibrillation in Pulmonary Embolism Study - SAFE-PE Study
調査の概要
詳細な説明
Patients included in the study might be referred for an ultrasound of deep vein thrombosis unless this has already been performed. Blood will be drawn in a subset of patients to assess cardiac biomarkers, and stored in a biobank for further analysis of thrombotic biomarkers. If a computed tomography (CT) angiogram was used as diagnostic method for pulmonary embolism a radiologic review will be performed to assess presence of right atrium thrombus, with the reviewer will be blinded to the presence of atrial fibrillation (AF). In addition, an echocardiogram of the heart will be performed.
Many patients with pulmonary embolism have prolonged symptoms of dyspnoea, and palpitations. These symptoms are also described in patients with atrial fibrillation. All participants will be asked to fill out a standardized quality of life (RAND-36)-, and a symptoms questionnaire (modified European Heart Rhythm association symptom scale). Upon inclusion all patients will be reviewed for factors predisposing to PE such as recent surgery, or illness requiring immobilisation within the past three months prior to index event.
After inclusion patients will be randomised to screening for atrial fibrillation or standard of care. Participants who get randomised into the screening arm will be screened for AF using a validated, handheld ECG device at least twice daily for two weeks. Participants who get AF diagnosed during the study will be referred for appropriate cardiology follow-up and the anticoagulant therapy will be changed from a fixed time to continued (subject to yearly reviews). Patients will then be followed for five years using the Swedish death registry, and the Swedish national patient registry, in combination with the national prescription registry for the outcomes.
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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Stockholm、スウェーデン、182 88
- Danderyd Hospital
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
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:
- Recent pulmonary embolism (within three months)
Fulfilling Chads-Vasc criteria for life-long oral anticoagulant therapy (2 points for men, and 3 points for women), or age > 65 years
Exclusion Criteria:
- Known diagnosis of atrial fibrillation Contra-indication to oral anticoagulant therapy Provoked pulmonary embolism in sub-segmental artery only Active cancer therapy (on-going therapy, recent surgery or life-expectancy below 1 year)
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：ふるい分け
- 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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介入なし：コントロールアーム
標準治療
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アクティブコンパレータ：Screening Arm
Screening for atrial fibrillation using a hand-held ECG device (Zenicor intermittent ECG) at least twice daily for two weeks.
In patients where AF is detected prolonged OAC therapy will be administered.
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At least two weeks of screening twice daily for atrial fibrillation using intermittent ECG recordings, and prolonged use of OAC-therapy if atrial fibrillation is detected
他の名前：
Selection of device for monitoring clinicians' choice
他の名前：
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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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Mortality
時間枠：5 years after intervention
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Mortality in the screening arm compared to the control arm
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5 years after intervention
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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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Mortality and thromboembolic events
時間枠：5 years after intervention
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Combined endpoint of mortality and thromboembolic events (stroke, transient ischemic attack, systemic embolism, deep vein thrombosis and pulmonary embolism) in the screening arm compared to the control arm
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5 years after intervention
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
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Quality of life using RAND-36
時間枠：1 year after inclusion
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All patients will fill in a quality of life questionnaire (RAND-36).
Quality of life will be compared in patients where AF is detected compared to the group where AF is not detected in patients with PE.
Quality of life will be measured using a RAND-36 questionnaire that uses questions regarding physical, mental and social wellbeing based on the World Health Organization's definition of health.
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1 year after inclusion
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Quality of life using EHRA symptom scale
時間枠：1 year after inclusion
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Quality of life will be compared in patients where AF is detected compared to the group where AF is not detected.
Quality of life will be measured using a modified European Heart Rhythm association (EHRA) symptom scale and reported as a separate outcome.
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1 year after inclusion
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Assessment of clinical risk factors for atrial fibrillation in patients with pulmonary embolism
時間枠：1 year after inclusion
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Comparison of clinical characteristics (diagnosis of prior hypertension, diabetes mellitus type 2, vascular disease, heart failure, stroke/TIA) to identify risk factors for detection of AF in patients with PE, and use to build a risk score for AF detection.
Patients in the intervention arm who had atrial fibrillation discovered after screening with intermittent ECG will be compared to participants in the intervention arm where atrial fibrillation was not discovered.
Multivariable logistic regression will be used to determine which risk factors are most important in order to detect previously undetected AF in patients with pulmonary embolism.
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1 year after inclusion
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Biomarkers as a prediction of diagnosis in pulmonary embolism
時間枠：5 years after inclusion
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The use of biomarkers to predict risk of future thromboembolic events and mortality in patients with PE.
Blood will be collected from the majority of participants in the stuydy and stored in a biobank.
Different biomarkers will be measured (for instance NT-proBNP, troponin, CRP and thromboembolic biomarkers) and the association between the levels of biomarkers and mortality, and thromboembolic morbitidy will be analysed using Cox proportional regression models.
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5 years after inclusion
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The association between biomarkers and newly detected AF in patients with pulmonary embolism
時間枠：1 years after inclusion
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Biomarkers will be collected in the majority of patients.
The levels of various biomarkers in the intervention group where AF was detected will be compared to participants in the intervention group where AF was not detected.
Multivariable logistic regression will be used to study the association between biomarkers and the detection of AF in patients with PE.
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1 years after inclusion
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Echocardiographic measures and their association with outcome in patients with PE
時間枠：5 years after inclusion
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Various echocardiographic parameters will be measured in all included patients.
The echocardiographic measures in patients in the study who had a secondary outcome will be compared to patients who did not have a secondary outcome.
Echocardiographic measures will be analysed using multivariable Cox regression analysis in order to find parameters that are associated with poor outcome.
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5 years after inclusion
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Echocardiographic parameters and their association with newly detected AF in patients with PE
時間枠：1 years after inclusion
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In the intervention arm echocardiographic parameters will be compared for the group where AF was detected compared to the group where AF was not detected.
Using multivariable logistic regression echocardiographic variables associated with the detection of atrial fibrillation in patients with pulmonary embolism will be studied.
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1 years after inclusion
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Presence of right atrial thrombus on DT angiography in PE
時間枠：5 years after inclusion
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In participants where DT angiography was used in order to diagnose PE the images will be reviewed in order assess whether a right atrial thrombi could be detected.
The outcome between participants with right atrial thrombus on DT angiography will be compared to participants who did not have right atrial thrombus on DT.
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5 years after inclusion
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Håkan Wallén, MD PhD、Karolinska Institutet - Danderyd Hospital
- 主任研究者：Emma Svennberg, MD PhD、Karolinska Institutet - Danderyd Hospital
研究記録日
主要日程の研究
研究開始 (実際)
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 (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。
Zenicor intermittent ECG deviceの臨床試験
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Karolinska University HospitalRoche Diagnostics積極的、募集していない