Status:
UNKNOWN
Prospective Evaluation of Long-term Outcomes After Pulmonary Embolism
Lead Sponsor:
Sir Mortimer B. Davis - Jewish General Hospital
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- First episode of acute symptomatic PE that was objectively diagnosed\* within last 10 days
- Treated with anticoagulants
- ≥ 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2015
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01174628
Start Date
June 1 2010
End Date
February 1 2015
Last Update
November 26 2014
Active Locations (5)
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1
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 2Y9
2
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9
3
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
4
Sir Mortimer B. Davis - Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2