Prospective Evaluation of Long-term Outcomes After Pulmonary Embolism (ELOPE)
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ClinicalTrials.gov Identifier: NCT01174628 |
Recruitment Status
: Unknown
Verified November 2014 by Dr. Susan Kahn, Sir Mortimer B. Davis - Jewish General Hospital.
Recruitment status was: Active, not recruiting
First Posted
: August 3, 2010
Last Update Posted
: November 26, 2014
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Condition or disease |
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Pulmonary Embolism |
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 |

- 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)
- 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).
Biospecimen Retention: Samples With DNA

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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 |
Inclusion Criteria:
- First episode of acute symptomatic PE that was objectively diagnosed* within last 10 days
- Treated with anticoagulants
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≥ 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:
- 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)
- Contraindication to CTPA (allergy to iodinated contrast, CrCl or eGFR < 30 ml/min)
- Severe comorbidity (congestive heart failure [LVEF < 35%], severe COPD or restrictive lung disease [FEV1<50%, chronic need for oxygen therapy])
- Previous DVT (as ~40% of patients with proximal DVT have asymptomatic PE on lung imaging 67)
- Life expectancy < 1 year (e.g. active or terminal cancer, end-stage cardiac or respiratory disease).
- Pregnancy or lactation
- Unable to read questionnaire in English or French
- Unable to return to study centre for required follow-up visits
- Unable or unwilling to provide written informed consent

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01174628
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 |
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Key Record Dates |
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 |