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Prospective Evaluation of Long-term Outcomes After Pulmonary Embolism

NCT ID: NCT01174628

Last Updated: 2014-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2015-02-28

Brief Summary

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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

Detailed Description

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Conditions

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Pulmonary Embolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sir Mortimer B. Davis - Jewish General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. Susan Kahn

M.D., M.Sc.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susan R Kahn, M.D., M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Sir Mortimer B. Davis - Jewish General Hospital

Andrew Hirsch, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sir Mortimer B. Davis - Jewish General Hospital

John Granton, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

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QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Site Status

The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status

Toronto General Hospital

Toronto, Ontario, Canada

Site Status

Sir Mortimer B. Davis - Jewish General Hospital

Montreal, Quebec, Canada

Site Status

St. Mary's Hospital Center

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 27932051 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24469387 (View on PubMed)

Other Identifiers

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MOP-93627

Identifier Type: -

Identifier Source: org_study_id