Hartfunctie bij door zwemmen veroorzaakt longoedeem (SIPE)
Hartfunctie bij door zwemmen geïnduceerd longoedeem (SIPE) - een case-control-onderzoek
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.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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).
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studie Locaties
-
-
-
Falun, Zweden, 79182
- Werving
- Center of Clinical Research Dalarna
-
Contact:
- Maria Hårdstedt, MD/PhD
- Telefoonnummer: +46 738089464
- E-mail: maria.hardstedt@regiondalarna.se
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
All adults (age ≥18 years) that participate in a swimming race during Vansbrosimningen open water swimming event.
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: CASE_CONTROL
- Tijdsperspectieven: PROSPECTIVE
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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) |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Acute Echocardiography
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 4-6 hours after termination of swimming
|
Venous samples. Measurement of NT-pro-BNP (ng/L) |
4-6 hours after termination of swimming
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Baseline Echocardiography
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: within 12 months after swimming
|
Venous samples. Measurement of NT-pro-BNP (ng/L). Examination at rest |
within 12 months after swimming
|
Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SIPE Cardiac function 001
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .