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Pulmonary EmbolismELOPENCT01174628

Prospective Evaluation of Long-term Outcomes After Pulmonary Embolism

An observational study of Pulmonary Embolism, run by Sir Mortimer B. Davis - Jewish General Hospital at 5 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Embolism
How many people
150 participants
Where
5 sitesCanada
Study dates
Jun 2010to Feb 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients seen in the Emergency Department, in-patient wards, out-patient clinics or anticoagulation clinics.

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Canada5 sites

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 2Y9

  • Sir Mortimer B. Davis - Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • St. Mary's Hospital Center

    Montreal, Quebec, H3T 1M5

  • The Ottawa Hospital

    Ottawa, Ontario, K1Y 4E9

  • Toronto General Hospital

    Toronto, Ontario, M5G 2N2

Other trials in Canada

About this study

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

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

Keywords
Exercise Tolerance, Venous Thrombosis, Pulmonary Embolism, Quality of Life (QOL)
Medical subject headings
Pulmonary Embolism, Venous Thrombosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Exercise Limitation

    Exercise limitation will be assessed by VO2 max (% predicted) on cardiopulmonary exercise testing (CPET)

    Measured: 1 month

  2. Exercise Limitation

    Exercise limitation will be assessed by VO2 max (% predicted) on cardiopulmonary exercise testing (CPET)

    Measured: 12 months

Secondary outcomes (10)

  1. Quality of Life

    Quality of Life will be assessed using the SF-36v2 questionnaire.

    Measured: Baseline

  2. Quality of Life

    Quality of Life will be assessed using the SF-36v2 questionnaire.

    Measured: 1 month

  3. Quality of Life

    Quality of Life will be assessed using the SF-36v2 questionnaire.

    Measured: 3 months

  4. Quality of Life

    Quality of Life will be assessed using the SF-36v2 questionnaire.

    Measured: 6 months

  5. Quality of Life

    Quality of Life will be assessed using the SF-36v2 questionnaire.

    Measured: 12 months

  6. 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).

    Measured: Baseline

  7. 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).

    Measured: 1 month

  8. 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).

    Measured: 3 months

  9. 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).

    Measured: 6 months

  10. 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).

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionDec 2014 (estimated)
  4. Study completionFeb 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01174628
Sponsor's protocol ID
MOP-93627
Acronym
ELOPE
Status last verified
Nov 2014
First submitted
28 Jul 2010
Last updated
26 Nov 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Kahn SR, Hirsch AM, Akaberi A, Hernandez P, Anderson DR, Wells PS, Rodger MA, Solymoss S, Kovacs MJ, Rudski L, Shimony A, Dennie C, Rush C, Geerts WH, Aaron SD, Granton JT. Functional and Exercise Limitations After a First Episode of Pulmonary Embolism: Results of the ELOPE Prospective Cohort Study. Chest. 2017 May;151(5):1058-1068. doi: 10.1016/j.chest.2016.11.030. Epub 2016 Dec 6.

    PubMed 27932051

  • Kahn SR, Houweling AH, Granton J, Rudski L, Dennie C, Hirsch A. Long-term outcomes after pulmonary embolism: current knowledge and future research. Blood Coagul Fibrinolysis. 2014 Jul;25(5):407-15. doi: 10.1097/MBC.0000000000000070.

    PubMed 24469387

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Embolism, run by Sir Mortimer B. Davis - Jewish General Hospital at 5 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Exercise Limitation (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01174628, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2014.

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