Czynność serca w obrzęku płuc wywołanym pływaniem (SIPE)
Czynność serca w obrzęku płuc wywołanym pływaniem (SIPE) — badanie kliniczno-kontrolne
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.
Przegląd badań
Status
Szczegółowy opis
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).
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Lokalizacje studiów
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Falun, Szwecja, 79182
- Rekrutacyjny
- Center of Clinical Research Dalarna
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Kontakt:
- Maria Hårdstedt, MD/PhD
- Numer telefonu: +46 738089464
- E-mail: maria.hardstedt@regiondalarna.se
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
All adults (age ≥18 years) that participate in a swimming race during Vansbrosimningen open water swimming event.
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: CASE_CONTROL
- Perspektywy czasowe: PROSPECTIVE
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
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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) |
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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) |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Acute Echocardiography
Ramy czasowe: within 4 hours after termination of swimming
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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
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|
Acute Electrocardiogram (ECG) - Rytm analysis
Ramy czasowe: within 4 hours after termination of swimming
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12-lead electrocardiogram (ECG). Rytm analysis and frequency (beats per minute) |
within 4 hours after termination of swimming
|
|
Acute Electrocardiogram (ECG) - Heart axis
Ramy czasowe: within 4 hours after termination of swimming
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12-lead electrocardiogram (ECG). Assessment of QRS-axis (degrees) |
within 4 hours after termination of swimming
|
|
Acute Electrocardiogram (ECG) - Amplitudes and intervals
Ramy czasowe: within 4 hours after termination of swimming
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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
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|
Acute Electrocardiogram (ECG) - Signs of myocardial ischemia
Ramy czasowe: within 4 hours after termination of swimming
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12-lead electrocardiogram (ECG). ST-elevation, ST-depression, T-wave inversion, Q wave. |
within 4 hours after termination of swimming
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Acute cardiac biomarkers - Troponin I
Ramy czasowe: 4-6 hours after termination of swimming
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Venous samples. Measurement of hs-Troponin I (ng/L). |
4-6 hours after termination of swimming
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Acute cardiac biomarkers - NT-pro-BNP
Ramy czasowe: 4-6 hours after termination of swimming
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Venous samples. Measurement of NT-pro-BNP (ng/L) |
4-6 hours after termination of swimming
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Baseline Echocardiography
Ramy czasowe: within 12 months after swimming
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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
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|
Baseline Electrocardiogram (ECG) - Rytm analysis
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: within 12 months after swimming
|
Venous samples. Measurement of NT-pro-BNP (ng/L). Examination at rest |
within 12 months after swimming
|
Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- SIPE Cardiac function 001
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
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