Clinical trial NCT01174628: Prospective Evaluation of Long-term Outcomes After Pulmonary Embolism
Official title: The ELOPE Study: Prospective Evaluation of Long-term Outcomes After Pulmonary Embolism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Embolism
Keywords: Exercise Tolerance
Venous Thrombosis
Pulmonary Embolism
Quality of Life (QOL)
Lead sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Sponsor class: OTHER
First posted: 2010-08-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients seen in the Emergency Department, in-patient wards, out-patient clinics or anticoagulation clinics.

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


Eligibility 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

Primary outcomes:
measure: Exercise Limitation
timeFrame: 1 month
measure: Exercise Limitation
timeFrame: 12 months
Secondary outcomes:
measure: Quality of Life
timeFrame: Baseline
measure: Quality of Life
timeFrame: 1 month
measure: Quality of Life
timeFrame: 3 months
measure: Quality of Life
timeFrame: 6 months
measure: Quality of Life
timeFrame: 12 months
measure: Respiratory Disease-Specific Measures
timeFrame: Baseline
measure: Respiratory Disease-Specific Measures
timeFrame: 1 month
measure: Respiratory Disease-Specific Measures
timeFrame: 3 months
measure: Respiratory Disease-Specific Measures
timeFrame: 6 months
measure: Respiratory Disease-Specific Measures
timeFrame: 12 months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Sir Mortimer B. Davis - Jewish General Hospital
state: Quebec
city: Montreal
country: Canada
facility: St. Mary's Hospital Center
state: Quebec
Study officials:
affiliation: Sir Mortimer B. Davis - Jewish General Hospital
name: Susan R Kahn, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Sir Mortimer B. Davis - Jewish General Hospital
name: Andrew Hirsch, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: John Granton, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.