水泳誘発性肺水腫（SIPE）における心機能
水泳誘発性肺水腫 (SIPE) における心機能 - 症例対照研究
Acute or chronic cardiac dysfunction could be a contributing factor to swimming-induced pulmonary edema (SIPE). Knowledge on cardiac function in SIPE is limited and recommendations for cardiac evaluation of patients with SIPE are lacking. The present study was designed to assess cardiac function in patients with SIPE and in asymptomatic swimmers.
調査の概要
状態
詳細な説明
Swimming induced pulmonary edema (SIPE) is an unusual condition occuring during swimming in cold open water. SIPE is characterized by acute onset of dyspnea and cough, excessive sputum and occasionally hemoptysis. Reversible myocardial dysfunction has been described in swimmers with SIPE and divers with immersion pulmonary edema (IPE). Cardiac dysfunction has also been discussed as a contributing factor triggering SIPE. However, prevalence, severity and prognosis of myocardial dysfunction in patients with SIPE is unknown. Official recommendations for cardiac evaluation of patients after an acute episode of SIPE is lacking.
This case-control-study intends to assess cardiac function in patients with SIPE and in asymptomatic swimmers. We study a large cohort of approximately 12 000 swimmers during Vansbrosimningen, Sweden's biggest annual open water event, with a yearly incidence of SIPE of about 0,4%. Cardiac function is evaluated after swimming as well as at rest by echocardiography, 12-lead electrocardiogram and cardiac biomarkers (Troponin I, NT-pro-BNP).
研究の種類
入学 (推定)
連絡先と場所
研究場所
-
-
-
Falun、スウェーデン、79182
- 募集
- Center of Clinical Research Dalarna
-
コンタクト：
- Maria Hårdstedt, MD/PhD
- 電話番号：+46 738089464
- メール：maria.hardstedt@regiondalarna.se
-
-
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
All adults (age ≥18 years) that participate in a swimming race during Vansbrosimningen open water swimming event.
説明
Inclusion Criteria:
for patients:
- respiratory symptoms during or after swimming at the Vansbrosimningen open water swimming event
- diagnosis SIPE by signs of pulmonary edema on lung ultrasound
- peripheral oxygen saturation ≤95%
for controls:
- completion of a swimming race of the Vansbrosimningen open water swimming event.
- no respiratory symptoms during or after swimming
- no signs of pulmonary edema on lung ultrasound
- matched to patients with SIPE regarding sex and age
Exclusion criteria:
- declined consent
- hemodynamic instability or decreased consciousness
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：CASE_CONTROL
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
patients with SIPE
Adult patients (age ≥18 years) with SIPE-diagnosis during "Vansbrosimningen" and peripheral oxygen saturation ≤95%. SIPE-diagnosis based on pulmonary edema on lung ultrasound. |
Echocardiography after swimming (acute) and at rest (baseline) Electrocardiogram (ECG) after swimming (acute) and at rest (baseline) high sensitive (hs)-Troponin I and N-terminal pro-brain natriuretic peptide (NT-pro-BNP) after swimming (acute) and at rest (baseline) |
|
control group
Swimmers completing "Vansbrosimningen" without respiratory symptoms or signs of pulmonary edema on lung ultrasound. Matched to patients with SIPE for age and gender. |
Echocardiography after swimming (acute) and at rest (baseline) Electrocardiogram (ECG) after swimming (acute) and at rest (baseline) high sensitive (hs)-Troponin I and N-terminal pro-brain natriuretic peptide (NT-pro-BNP) after swimming (acute) and at rest (baseline) |
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 |
|---|---|---|
|
Acute Echocardiography
時間枠：within 4 hours after termination of swimming
|
Transthoracic echocardiography with parasternal, apical and subcostal views. Including measurement of ventricular wall size, left ventricular strain, ejection fraction according to the modified Simpson method, diastolic function (using tissue doppler, mitral flow and pulmonary vein flow), right ventricular tricuspid annular plane systolic excursion (TAPSE), pressure gradient over the tricuspid valve, assessment of valve dysfunction, size and respiratory variation of the inferior vena cava, assessment of pericardial fluid. |
within 4 hours after termination of swimming
|
|
Acute Electrocardiogram (ECG) - Rytm analysis
時間枠：within 4 hours after termination of swimming
|
12-lead electrocardiogram (ECG). Rytm analysis and frequency (beats per minute) |
within 4 hours after termination of swimming
|
|
Acute Electrocardiogram (ECG) - Heart axis
時間枠：within 4 hours after termination of swimming
|
12-lead electrocardiogram (ECG). Assessment of QRS-axis (degrees) |
within 4 hours after termination of swimming
|
|
Acute Electrocardiogram (ECG) - Amplitudes and intervals
時間枠：within 4 hours after termination of swimming
|
12-lead electrocardiogram (ECG). Duration of PQ-interval (ms), QRS-complex (ms), QT-interval (ms), QRS amplitude (mV) |
within 4 hours after termination of swimming
|
|
Acute Electrocardiogram (ECG) - Signs of myocardial ischemia
時間枠：within 4 hours after termination of swimming
|
12-lead electrocardiogram (ECG). ST-elevation, ST-depression, T-wave inversion, Q wave. |
within 4 hours after termination of swimming
|
|
Acute cardiac biomarkers - Troponin I
時間枠：4-6 hours after termination of swimming
|
Venous samples. Measurement of hs-Troponin I (ng/L). |
4-6 hours after termination of swimming
|
|
Acute cardiac biomarkers - NT-pro-BNP
時間枠：4-6 hours after termination of swimming
|
Venous samples. Measurement of NT-pro-BNP (ng/L) |
4-6 hours after termination of swimming
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Baseline Echocardiography
時間枠：within 12 months after swimming
|
Transthoracic echocardiography with parasternal, apical and subcostal views. Examination at rest. Including measurement of ventricular wall size, left ventricular strain, ejection fraction according to the modified Simpson method, diastolic function (using tissue doppler, mitral flow and pulmonary vein flow), right ventricular tricuspid annular plane systolic excursion (TAPSE), pressure gradient over the tricuspid valve, assessment of valve dysfunction, size and respiratory variation of the inferior vena cava, assessment of pericardial fluid. |
within 12 months after swimming
|
|
Baseline Electrocardiogram (ECG) - Rytm analysis
時間枠：within 12 months after swimming
|
12-lead Electrocardiogram (ECG). Examination at rest. Rytm analysis and frequency (beats per minute) |
within 12 months after swimming
|
|
Baseline Electrocardiogram (ECG)- Heart axis
時間枠：within 12 months after swimming
|
12-lead Electrocardiogram (ECG). Examination at rest. Assessment of QRS-axis (degrees) |
within 12 months after swimming
|
|
Baseline Electrocardiogram (ECG) - Amplitudes and intervals
時間枠：within 12 months after swimming
|
12-lead Electrocardiogram (ECG). Examination at rest. Duration of PQ-interval (ms), QRS-complex (ms), QT-interval (ms), QRS amplitude (mV) |
within 12 months after swimming
|
|
Baseline Electrocardiogram (ECG) - Signs of myocardial ischemia
時間枠：within 12 months after swimming
|
12-lead Electrocardiogram (ECG). Examination at rest. ST-elevation, ST-depression, T-wave inversion, Q wave. |
within 12 months after swimming
|
|
Baseline cardiac biomarkers - Troponin I
時間枠：within 12 months after swimming
|
Venous samples. Measurement of hs-Troponin I (ng/L). Examination at rest |
within 12 months after swimming
|
|
Baseline cardiac biomarkers - NT-pro-BNP
時間枠：within 12 months after swimming
|
Venous samples. Measurement of NT-pro-BNP (ng/L). Examination at rest |
within 12 months after swimming
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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。