跳至主要内容
临床试验/NCT05391737
NCT05391737招募中不适用

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

Dalarna County Council, Sweden1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年7月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Acute cardiac biomarkers - Troponin I

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

Acute cardiac biomarkers - Troponin I

时间窗: 4-6 hours after termination of swimming

Venous samples. Measurement of hs-Troponin I (ng/L).

Acute cardiac biomarkers - NT-pro-BNP

时间窗: 4-6 hours after termination of swimming

Venous samples. Measurement of NT-pro-BNP (ng/L)

Acute Electrocardiogram (ECG) - Amplitudes and intervals

时间窗: 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)

Acute Echocardiography

时间窗: 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.

Acute Electrocardiogram (ECG) - Rytm analysis

时间窗: within 4 hours after termination of swimming

12-lead electrocardiogram (ECG). Rytm analysis and frequency (beats per minute)

Acute Electrocardiogram (ECG) - Heart axis

时间窗: within 4 hours after termination of swimming

12-lead electrocardiogram (ECG). Assessment of QRS-axis (degrees)

Acute Electrocardiogram (ECG) - Signs of myocardial ischemia

时间窗: within 4 hours after termination of swimming

12-lead electrocardiogram (ECG). ST-elevation, ST-depression, T-wave inversion, Q wave.

次要结局

  • Baseline Electrocardiogram (ECG) - Signs of myocardial ischemia(within 12 months after swimming)
  • Baseline cardiac biomarkers - NT-pro-BNP(within 12 months after swimming)
  • Baseline Electrocardiogram (ECG) - Amplitudes and intervals(within 12 months after swimming)
  • Baseline Echocardiography(within 12 months after swimming)
  • Baseline Electrocardiogram (ECG) - Rytm analysis(within 12 months after swimming)
  • Baseline Electrocardiogram (ECG)- Heart axis(within 12 months after swimming)
  • Baseline cardiac biomarkers - Troponin I(within 12 months after swimming)

研究者

发起方
Dalarna County Council, Sweden
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Hårdstedt

Dr. Maria Hårdstedt, PhD, Specialist Internal Medicine

Dalarna County Council, Sweden

研究点 (1)

Loading locations...

相似试验