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Prospective Evaluation of Long-term Outcomes After Pulmonary Embolism (ELOPE)

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ClinicalTrials.gov Identifier: NCT01174628
Recruitment Status : Unknown
Verified November 2014 by Dr. Susan Kahn, Sir Mortimer B. Davis - Jewish General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : August 3, 2010
Last Update Posted : November 26, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease
Pulmonary Embolism

Study Design

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The ELOPE Study: Prospective Evaluation of Long-term Outcomes After Pulmonary Embolism
Study Start Date : June 2010
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Exercise Limitation [ Time Frame: 1 month ]
    Exercise limitation will be assessed by VO2 max (% predicted) on cardiopulmonary exercise testing (CPET)

  2. Exercise Limitation [ Time Frame: 12 months ]
    Exercise limitation will be assessed by VO2 max (% predicted) on cardiopulmonary exercise testing (CPET)


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: Baseline ]
    Quality of Life will be assessed using the SF-36v2 questionnaire.

  2. Quality of Life [ Time Frame: 1 month ]
    Quality of Life will be assessed using the SF-36v2 questionnaire.

  3. Quality of Life [ Time Frame: 3 months ]
    Quality of Life will be assessed using the SF-36v2 questionnaire.

  4. Quality of Life [ Time Frame: 6 months ]
    Quality of Life will be assessed using the SF-36v2 questionnaire.

  5. Quality of Life [ Time Frame: 12 months ]
    Quality of Life will be assessed using the SF-36v2 questionnaire.

  6. Respiratory Disease-Specific Measures [ Time Frame: Baseline ]
    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).

  7. Respiratory Disease-Specific Measures [ Time Frame: 1 month ]
    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).

  8. Respiratory Disease-Specific Measures [ Time Frame: 3 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).

  9. Respiratory Disease-Specific Measures [ Time Frame: 6 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).

  10. Respiratory Disease-Specific Measures [ Time Frame: 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).


Biospecimen Retention:   Samples With DNA
platelet-poor plasma

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients seen in the Emergency Department, in-patient wards, out-patient clinics or anticoagulation clinics.
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01174628


Locations
Canada, Nova Scotia
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
Canada, Quebec
Sir Mortimer B. Davis - Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
St. Mary's Hospital Center
Montreal, Quebec, Canada, H3T 1M5
Sponsors and Collaborators
Sir Mortimer B. Davis - Jewish General Hospital
Investigators
Principal Investigator: Susan R Kahn, M.D., M.Sc. Sir Mortimer B. Davis - Jewish General Hospital
Principal Investigator: Andrew Hirsch, M.D. Sir Mortimer B. Davis - Jewish General Hospital
Principal Investigator: John Granton, M.D. University of Toronto
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Susan Kahn, M.D., M.Sc., Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier: NCT01174628     History of Changes
Other Study ID Numbers: MOP-93627
First Posted: August 3, 2010    Key Record Dates
Last Update Posted: November 26, 2014
Last Verified: November 2014

Keywords provided by Dr. Susan Kahn, Sir Mortimer B. Davis - Jewish General Hospital:
Exercise Tolerance
Venous Thrombosis
Pulmonary Embolism
Quality of Life (QOL)

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases