Prospective Evaluation of Long-term Outcomes After Pulmonary Embolism (ELOPE)

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

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

Study Overview

• Status: Unknown
• Conditions: Pulmonary Embolism

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • QEII Health Sciences Centre
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4E9
      • The Ottawa Hospital
    • Toronto, Ontario, Canada, M5G 2N2
      • Toronto General Hospital
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Sir Mortimer B. Davis - Jewish General Hospital
    • Montreal, Quebec, Canada, H3T 1M5
      • St. Mary's Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients seen in the Emergency Department, in-patient wards, out-patient clinics or anticoagulation clinics.

Description

Inclusion Criteria:

1. First episode of acute symptomatic PE that was objectively diagnosed* within last 10 days
2. Treated with anticoagulants

3. ≥ 18 years old

   • PE will be diagnosed if there is a high probability V/Q scan (as per PIOPED Study criteria 66), an intraluminal filling defect in segmental or larger vessels on CTPA or a constant intraluminal filling defect or abrupt cut-off of vessels greater than 2.5 mm diameter on pulmonary angiography 8,10. Patients with non-definitive test results (e.g. low or intermediate probability V/Q scan, subsegmental PE on CTPA (~5% of PE patients 12) will not be included in order to have a strictly defined population of patients with definite PE.

Exclusion Criteria:

1. Contraindication or unable to perform CPET or 6MWT (amputated or paralyzed limb(s), severe lower extremity arthritis, preexisting cardiopulmonary condition precluding exercise including unstable angina or myocardial infarction in last 6 weeks, uncontrolled hypertension, serious cardiac dysrhythmia on resting EKG [severe bradycardia or tachycardia, sick sinus syndrome or multifocal premature ventricular contractions] and syncope)
2. Contraindication to CTPA (allergy to iodinated contrast, CrCl or eGFR < 30 ml/min)
3. Severe comorbidity (congestive heart failure [LVEF < 35%], severe COPD or restrictive lung disease [FEV1<50%, chronic need for oxygen therapy])
4. Previous DVT (as ~40% of patients with proximal DVT have asymptomatic PE on lung imaging 67)
5. Life expectancy < 1 year (e.g. active or terminal cancer, end-stage cardiac or respiratory disease).
6. Pregnancy or lactation
7. Unable to read questionnaire in English or French
8. Unable to return to study centre for required follow-up visits
9. Unable or unwilling to provide written informed consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise Limitation	Exercise limitation will be assessed by VO2 max (% predicted) on cardiopulmonary exercise testing (CPET)	1 month
Exercise Limitation	Exercise limitation will be assessed by VO2 max (% predicted) on cardiopulmonary exercise testing (CPET)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	Quality of Life will be assessed using the SF-36v2 questionnaire.	Baseline
Quality of Life	Quality of Life will be assessed using the SF-36v2 questionnaire.	1 month
Quality of Life	Quality of Life will be assessed using the SF-36v2 questionnaire.	3 months
Quality of Life	Quality of Life will be assessed using the SF-36v2 questionnaire.	6 months
Quality of Life	Quality of Life will be assessed using the SF-36v2 questionnaire.	12 months
Respiratory Disease-Specific Measures	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).	Baseline
Respiratory Disease-Specific Measures	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).	1 month
Respiratory Disease-Specific Measures	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).	3 months
Respiratory Disease-Specific Measures	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).	6 months
Respiratory Disease-Specific Measures	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).	12 months

Collaborators and Investigators

• Sponsor: Sir Mortimer B. Davis - Jewish General Hospital
• Investigators: Principal Investigator: Susan R Kahn, M.D., M.Sc., Sir Mortimer B. Davis - Jewish General Hospital; Principal Investigator: Andrew Hirsch, M.D., Sir Mortimer B. Davis - Jewish General Hospital; Principal Investigator: John Granton, M.D., University of Toronto

Publications and helpful links

General Publications

• Kahn SR, Hirsch AM, Akaberi A, Hernandez P, Anderson DR, Wells PS, Rodger MA, Solymoss S, Kovacs MJ, Rudski L, Shimony A, Dennie C, Rush C, Geerts WH, Aaron SD, Granton JT. Functional and Exercise Limitations After a First Episode of Pulmonary Embolism: Results of the ELOPE Prospective Cohort Study. Chest. 2017 May;151(5):1058-1068. doi: 10.1016/j.chest.2016.11.030. Epub 2016 Dec 6.
• Kahn SR, Houweling AH, Granton J, Rudski L, Dennie C, Hirsch A. Long-term outcomes after pulmonary embolism: current knowledge and future research. Blood Coagul Fibrinolysis. 2014 Jul;25(5):407-15. doi: 10.1097/MBC.0000000000000070.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): February 1, 2015

Study Registration Dates

• First Submitted: July 28, 2010
• First Submitted That Met QC Criteria: August 2, 2010
• First Posted (Estimate): August 3, 2010

Study Record Updates

• Last Update Posted (Estimate): November 26, 2014
• Last Update Submitted That Met QC Criteria: November 24, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Exercise Tolerance; Pulmonary Embolism; Venous Thrombosis; Quality of Life (QOL)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism
• Other Study ID Numbers: MOP-93627