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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Condition or disease
Pulmonary Embolism

Study Design

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Study Type :	Observational
Estimated Enrollment :	150 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	The ELOPE Study: Prospective Evaluation of Long-term Outcomes After Pulmonary Embolism
Study Start Date :	June 2010
Estimated Primary Completion Date :	December 2014
Estimated Study Completion Date :	February 2015

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Quality of Life [ Time Frame: Baseline ]
   Quality of Life will be assessed using the SF-36v2 questionnaire.
2. Quality of Life [ Time Frame: 1 month ]
   Quality of Life will be assessed using the SF-36v2 questionnaire.
3. Quality of Life [ Time Frame: 3 months ]
   Quality of Life will be assessed using the SF-36v2 questionnaire.
4. Quality of Life [ Time Frame: 6 months ]
   Quality of Life will be assessed using the SF-36v2 questionnaire.
5. Quality of Life [ Time Frame: 12 months ]
   Quality of Life will be assessed using the SF-36v2 questionnaire.
6. 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).
7. 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).
8. 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).
9. 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).
10. 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).

Biospecimen Retention:   Samples With DNA

platelet-poor plasma

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

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

Criteria

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

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

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Review.

Responsible Party:	Dr. Susan Kahn, M.D., M.Sc., Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier:	NCT01174628 History of Changes
Other Study ID Numbers:	MOP-93627
First Posted:	August 3, 2010
Last Update Posted:	November 26, 2014
Last Verified:	November 2014

Keywords provided by Dr. Susan Kahn, Sir Mortimer B. Davis - Jewish General Hospital:

Exercise Tolerance; Venous Thrombosis; Pulmonary Embolism; Quality of Life (QOL)

Additional relevant MeSH terms:

Embolism; Pulmonary Embolism; Embolism and Thrombosis; Vascular Diseases	Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases