Prospective Evaluation of Long-term Outcomes After Pulmonary Embolism (ELOPE)
This study is currently recruiting participants.
Verified June 2012 by Sir Mortimer B. Davis - Jewish General Hospital
Sponsor:
Sir Mortimer B. Davis - Jewish General Hospital
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 12, 2012
Last verified: June 2012
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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: | June 2014 |
| Estimated Primary Completion Date: | June 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:
- 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 Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01174628
Contacts
| Contact: Susan R Kahn, M.D., M.Sc. | 514-340-8222 ext 4667 | susan.kahn@mcgill.ca |
| Contact: Andrew Hirsch, M.D. | 514-340-8222 ext 5119 | ahirsch@pne.jgh.mcgill.ca |
Locations
| Canada, Nova Scotia | |
| QEII Health Sciences Centre | Recruiting |
| Halifax, Nova Scotia, Canada, B3H 2Y9 | |
| Contact: David Anderson, M.D. 902-473-8562 david.anderson@cdha.nshealth.ca | |
| Principal Investigator: David Anderson, M.D. | |
| Sub-Investigator: Paul Hernandez, M.D. | |
| Canada, Ontario | |
| London Health Sciences Centre | Withdrawn |
| London, Ontario, Canada, N6A 4G5 | |
| The Ottawa Hospital | Recruiting |
| Ottawa, Ontario, Canada, K1Y 4E9 | |
| Contact: Phil Wells, M.Sc., M.D. 613-761-4127 pwells@ohri.ca | |
| Principal Investigator: Phil Wells, M.Sc., M.D. | |
| Sub-Investigator: Shawn Aaron, M.Sc., M.D. | |
| Sub-Investigator: Carole Dennie, M.D. | |
| Sub-Investigator: Marc Rodger, M.Sc., M.D. | |
| Toronto General Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2N2 | |
| Contact: John Granton, M.D. 416-340-4485 john.granton@uhn.on.ca | |
| Principal Investigator: John Granton, M.D. | |
| Sub-Investigator: William Geerts, M.D. | |
| Canada, Quebec | |
| Sir Mortimer B. Davis - Jewish General Hospital | Recruiting |
| Montreal, Quebec, Canada, H3T 1E2 | |
| Contact: Susan R Kahn, M.Sc., M.D. 514.340.8222 ext 4667 susan.kahn@mcgill.ca | |
| Contact: Andrew Hirsch, M.D. 514.340.8222 ext 5119 ahirsch@pne.jgh.mcgill.ca | |
| Principal Investigator: Susan R Kahn, M.Sc., M.D. | |
| Principal Investigator: Andrew Hirsch, M.D. | |
| Sub-Investigator: Lawrence Rudski, M.D. | |
| Sub-Investigator: Christina Holcroft, Ph.D. | |
| Sub-Investigator: Eddy Lang, M.D. | |
| St. Mary's Hospital Center | Not yet recruiting |
| Montreal, Quebec, Canada, H3T 1M5 | |
| Contact: Susan Solymoss, M.D. 514-345-3511 | |
| Principal Investigator: Susan Solymoss, M.D. | |
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 12, 2012 |
| 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 Embolism and Thrombosis Vascular Diseases |
Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013