Prospective Evaluation of Long-term Outcomes After Pulmonary Embolism

• Conditions: Pulmonary Embolism

• Registration Number: NCT01174628
• Lead Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-07-28
• Study First Submitted QC: 2010-08-02
• Study First Posted: 2010-08-03
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-24
• Last Update Posted: 2014-11-26
• Primary Completion: 2014-12
• Study Completion: 2015-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Exercise Limitation	12 months	Exercise limitation will be assessed by VO2 max (% predicted) on cardiopulmonary exercise testing (CPET)

Secondary Outcome Measures

Name	Time	Method
Quality of Life	12 months	Quality of Life will be assessed using the SF-36v2 questionnaire.
Respiratory Disease-Specific Measures	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).

Trial Locations

Locations (5)

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

QEII Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada

Sir Mortimer B. Davis - Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

St. Mary's Hospital Center; 🇨🇦 Montreal, Quebec, Canada