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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dr. Susan Kahn, Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier:
NCT01174628
First received: July 28, 2010
Last updated: June 5, 2013
Last verified: June 2013
  Purpose

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
Pulmonary Embolism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The ELOPE Study: Prospective Evaluation of Long-term Outcomes After Pulmonary Embolism

Resource links provided by NLM:


Further study details as provided by Sir Mortimer B. Davis - Jewish General Hospital:

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

  • Exercise Limitation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Exercise limitation will be assessed by VO2 max (% predicted) on cardiopulmonary exercise testing (CPET)


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Quality of Life will be assessed using the SF-36v2 questionnaire.

  • Quality of Life [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Quality of Life will be assessed using the SF-36v2 questionnaire.

  • Quality of Life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Quality of Life will be assessed using the SF-36v2 questionnaire.

  • Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Quality of Life will be assessed using the SF-36v2 questionnaire.

  • Quality of Life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Quality of Life will be assessed using the SF-36v2 questionnaire.

  • Respiratory Disease-Specific Measures [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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).

  • Respiratory Disease-Specific Measures [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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).

  • Respiratory Disease-Specific Measures [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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).

  • Respiratory Disease-Specific Measures [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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).

  • Respiratory Disease-Specific Measures [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 150
Study Start Date: June 2010
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 28, 2010
Last Updated: June 5, 2013
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on October 23, 2014