Prospective Evaluation of Long-term Outcomes After Pulmonary Embolism

NCT01174628 | Unknown DMC

• 1 other identifier: MOP-93627
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 5

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

Conditions

Pulmonary Embolism

Keywords

Exercise Tolerance; Venous Thrombosis; Pulmonary Embolism; Quality of Life (QOL)

Outcome Measures

Primary Outcomes (2)

• Exercise Limitation

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

  1 month

• Exercise Limitation

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

  12 months

Secondary Outcomes (10)

• Quality of Life

  Baseline

• Quality of Life

  1 month

• Quality of Life

  3 months

• Quality of Life

  6 months

• Quality of Life

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital: lead

Study Sites (5)

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

Sir Mortimer B. Davis - Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

St. Mary's Hospital Center

Montreal, Quebec, H3T 1M5, Canada

Location

Related Publications (2)

• 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.

  PMID: 27932051 DERIVED

• 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.

  PMID: 24469387 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

platelet-poor plasma

MeSH Terms

Conditions

Pulmonary Embolism; Venous Thrombosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., M.Sc.

Study Record Dates

• First Submitted: July 28, 2010
• First Posted: August 3, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: February 1, 2015
• Last Updated: November 26, 2014

Record last verified: 2014-11

Locations

CA (5)