Clinical Trial: Prospective Evaluation of Long-term Outcomes After Pulmonary Embolism

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

Official Title: The ELOPE Study: Prospective Evaluation of Long-term Outcomes After Pulmonary Embolism

Brief Summary: The purpose of this study is to evaluate the long-term impact of Pulmonary Embolism (PE) on heart and lung function, quality of life, ability to work, symptoms of breathlessness and functional status of patients one year after their initial diagnosis and treatment for PE

Detailed Summary:
Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

Current Primary Outcome:

• Exercise Limitation [ Time Frame: 1 month ]
  Exercise limitation will be assessed by VO2 max (% predicted) on cardiopulmonary exercise testing (CPET)
• Exercise Limitation [ Time Frame: 12 months ]
  Exercise limitation will be assessed by VO2 max (% predicted) on cardiopulmonary exercise testing (CPET)

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Quality of Life [ Time Frame: Baseline ]
  Quality of Life will be assessed using the SF-36v2 questionnaire.
• Quality of Life [ Time Frame: 1 month ]
  Quality of Life will be assessed using the SF-36v2 questionnaire.
• Quality of Life [ Time Frame: 3 months ]
  Quality of Life will be assessed using the SF-36v2 questionnaire.
• Quality of Life [ Time Frame: 6 months ]
  Quality of Life will be assessed using the SF-36v2 questionnaire.
• Quality of Life [ Time Frame: 12 months ]
  Quality of Life will be assessed using the SF-36v2 questionnaire.
• Respiratory Disease-Specific Measures [ Time Frame: Baseline ]
  Respiratory Disease-Specific measures will be assessed using the Pulmonary Embolism Quality of Life Questionnaire (PEmb-QOL) and the San Diego Shortness of Breath Questionnaire (SOBQ).
• Respiratory Disease-Specific Measures [ Time Frame: 1 month ]
  Respiratory Disease-Specific measures will be assessed using the Pulmonary Embolism Quality of Life Questionnaire (PEmb-QOL) and the San Diego Shortness of Breath Questionnaire (SOBQ).
• Respiratory Disease-Specific Measures [ Time Frame: 3 months ]
  Respiratory Disease-Specific measures will be assessed using the Pulmonary Embolism Quality of Life Questionnaire (PEmb-QOL) and the San Diego Shortness of Breath Questionnaire (SOBQ).
• Respiratory Disease-Specific Measures [ Time Frame: 6 months ]
  Respiratory Disease-Specific measures will be assessed using the Pulmonary Embolism Quality of Life Questionnaire (PEmb-QOL) and the San Diego Shortness of Breath Questionnaire (SOBQ).
• Respiratory Disease-Specific Measures [ Time Frame: 12 months ]
  Respiratory Disease-Specific measures will be assessed using the Pulmonary Embolism Quality of Life Questionnaire (PEmb-QOL) and the San Diego Shortness of Breath Questionnaire (SOBQ).

Original Secondary Outcome:

• Quality of Life [ Time Frame: Baseline ]
  Quality of Life will be assessed using the SF-36v2 questionnaire.
• Quality of Life [ Time Frame: 1 month ]
  Quality of Life will be assessed using the SF-36v2 questionnaire.
• Quality of Life [ Time Frame: 3 months ]
  Quality of Life will be assessed using the SF-36v2 questionnaire.
• Quality of Life [ Time Frame: 6 months ]
  Quality of Life will be assessed using the SF-36v2 questionnaire.
• Quality of Life [ Time Frame: 12 months ]
  Quality of Life will be assessed using the SF-36v2 questionnaire.
• Respiratory Disease-Specific Measures [ Time Frame: Baseline ]
  Respiratory Disease-Specific measures will be assessed using the St-George's Respiratory Questionnaire (SGRQ) and the San Diego Shortness of Breath Questionnaire (SOBQ).
• Respiratory Disease-Specific Measures [ Time Frame: 1 month ]
  Respiratory Disease-Specific measures will be assessed using the St-George's Respiratory Questionnaire (SGRQ) and the San Diego Shortness of Breath Questionnaire (SOBQ).
• Respiratory Disease-Specific Measures [ Time Frame: 3 months ]
  Respiratory Disease-Specific measures will be assessed using the St-George's Respiratory Questionnaire (SGRQ) and the San Diego Shortness of Breath Questionnaire (SOBQ).
• Respiratory Disease-Specific Measures [ Time Frame: 6 months ]
  Respiratory Disease-Specific measures will be assessed using the St-George's Respiratory Questionnaire (SGRQ) and the San Diego Shortness of Breath Questionnaire (SOBQ).
• Respiratory Disease-Specific Measures [ Time Frame: 12 months ]
  Respiratory Disease-Specific measures will be assessed using the St-George's Respiratory Questionnaire (SGRQ) and the San Diego Shortness of Breath Questionnaire (SOBQ).

Information By: Sir Mortimer B. Davis - Jewish General Hospital

Dates:
Date Received: July 28, 2010
Date Started: June 2010
Date Completion: February 2015
Last Updated: November 24, 2014
Last Verified: November 2014