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Идёт набор NCT05391737

Cardiac Function in Swimming-Induced Pulmonary Edema (SIPE)

— Наблюдательное Swimming Induced Pulmonary Edema (SIPE) Pulmonary Edema Lung Diseases Heart Function Tests

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Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Echocardiography, Electrocardiogram (ECG), Cardiac biomarkers.
Кому может быть актуально
Состояния в реестре: Swimming Induced Pulmonary Edema (SIPE), Pulmonary Edema, Lung Diseases, Heart Function Tests. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швеция
Следующий шаг
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Официальное название

Cardiac Function in Swimming-Induced Pulmonary Edema (SIPE) - a Case Control Study

Обзор

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.

Подробное описание

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).

Вмешательства

  • Диагностический тест Echocardiography
    Echocardiography after swimming (acute) and at rest (baseline)
  • Диагностический тест Electrocardiogram (ECG)
    Electrocardiogram (ECG) after swimming (acute) and at rest (baseline)
  • Диагностический тест Cardiac biomarkers
    high sensitive (hs)-Troponin I and N-terminal pro-brain natriuretic peptide (NT-pro-BNP) after swimming (acute) and at rest (baseline)

Первичные конечные точки

  • Acute Echocardiography [Срок оценки: within 4 hours after termination of swimming]
  • Acute Electrocardiogram (ECG) - Rytm analysis [Срок оценки: within 4 hours after termination of swimming]
  • Acute Electrocardiogram (ECG) - Heart axis [Срок оценки: within 4 hours after termination of swimming]
  • Acute Electrocardiogram (ECG) - Amplitudes and intervals [Срок оценки: within 4 hours after termination of swimming]
  • Acute Electrocardiogram (ECG) - Signs of myocardial ischemia [Срок оценки: within 4 hours after termination of swimming]
  • Acute cardiac biomarkers - Troponin I [Срок оценки: 4-6 hours after termination of swimming]
  • Acute cardiac biomarkers - NT-pro-BNP [Срок оценки: 4-6 hours after termination of swimming]
Вторичные конечные точки (7)
  • Baseline Echocardiography [Срок оценки: within 12 months after swimming]
  • Baseline Electrocardiogram (ECG) - Rytm analysis [Срок оценки: within 12 months after swimming]
  • Baseline Electrocardiogram (ECG)- Heart axis [Срок оценки: within 12 months after swimming]
  • Baseline Electrocardiogram (ECG) - Amplitudes and intervals [Срок оценки: within 12 months after swimming]
  • Baseline Electrocardiogram (ECG) - Signs of myocardial ischemia [Срок оценки: within 12 months after swimming]
  • Baseline cardiac biomarkers - Troponin I [Срок оценки: within 12 months after swimming]
  • Baseline cardiac biomarkers - NT-pro-BNP [Срок оценки: within 12 months after swimming]

Критерии участия

Критерии включения

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

Критерии исключения

  • declined consent
  • hemodynamic instability or decreased consciousness

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Швеция · 1 центр
  • Center of Clinical Research Dalarna — Falun

Публикации

  • Seiler C, Torola M, Knuts U, Holm L, Magnusson B, Rask P, Nilsson KF, Hardstedt M. CARDIAC FINDINGS IN SWIMMING-INDUCED PULMONARY EDEMA - IMPLICATIONS FOR ACUTE ASSESSMENT. Chest. 2026 Jul 10:S0012-3692(26)00962-1. doi: 10.1016/j.chest.2026.06.051. Online ahead of print. PMID 42431395

Идентификаторы

NCT: NCT05391737 · SIPE Cardiac function 001

Первоисточники (государственные реестры)

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