Prospective Evaluation of Long-term Outcomes After Pulmonary Embolism

Pulmonary Embolism Clinical Trial

— ELOPE  

Official title:

The ELOPE Study: Prospective Evaluation of Long-term Outcomes After Pulmonary Embolism

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01174628
• Other study ID #: MOP-93627
• Status: Active, not recruiting
• Phase: N/A
• First received: July 28, 2010
• Last updated: November 24, 2014
• Start date: June 2010
• Est. completion date: February 2015

Study information

• Verified date: November 2014
• Source: Sir Mortimer B. Davis - Jewish General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Locations

Country	Name	City	State
Canada	QEII Health Sciences Centre	Halifax	Nova Scotia
Canada	Sir Mortimer B. Davis - Jewish General Hospital	Montreal	Quebec
Canada	St. Mary's Hospital Center	Montreal	Quebec
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sir Mortimer B. Davis - Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise Limitation	Exercise limitation will be assessed by VO2 max (% predicted) on cardiopulmonary exercise testing (CPET)	1 month	Yes
Primary	Exercise Limitation	Exercise limitation will be assessed by VO2 max (% predicted) on cardiopulmonary exercise testing (CPET)	12 months	Yes
Secondary	Quality of Life	Quality of Life will be assessed using the SF-36v2 questionnaire.	Baseline	No
Secondary	Quality of Life	Quality of Life will be assessed using the SF-36v2 questionnaire.	1 month	No
Secondary	Quality of Life	Quality of Life will be assessed using the SF-36v2 questionnaire.	3 months	No
Secondary	Quality of Life	Quality of Life will be assessed using the SF-36v2 questionnaire.	6 months	No
Secondary	Quality of Life	Quality of Life will be assessed using the SF-36v2 questionnaire.	12 months	No
Secondary	Respiratory Disease-Specific Measures	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).	Baseline	No
Secondary	Respiratory Disease-Specific Measures	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).	1 month	No
Secondary	Respiratory Disease-Specific Measures	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).	3 months	No
Secondary	Respiratory Disease-Specific Measures	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).	6 months	No
Secondary	Respiratory Disease-Specific Measures	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).	12 months	No