Overview

This trial is active, not recruiting.

Condition pulmonary embolism
Sponsor Sir Mortimer B. Davis - Jewish General Hospital
Start date June 2010
End date December 2014
Trial size 150 participants
Trial identifier NCT01174628, MOP-93627

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Exercise Limitation
time frame: 1 month
Exercise Limitation
time frame: 12 months

Secondary Outcomes

Measure
Quality of Life
time frame: Baseline
Quality of Life
time frame: 1 month
Quality of Life
time frame: 3 months
Quality of Life
time frame: 6 months
Quality of Life
time frame: 12 months
Respiratory Disease-Specific Measures
time frame: Baseline
Respiratory Disease-Specific Measures
time frame: 1 month
Respiratory Disease-Specific Measures
time frame: 3 months
Respiratory Disease-Specific Measures
time frame: 6 months
Respiratory Disease-Specific Measures
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title The ELOPE Study: Prospective Evaluation of Long-term Outcomes After Pulmonary Embolism
Principal investigator Susan R Kahn, M.D., M.Sc.
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Sir Mortimer B. Davis - Jewish General Hospital.