Please select the eligibility criteria that correspond to the clinical trial below.
Title: The ELOPE Study: Prospective Evaluation of Long-term Outcomes After Pulmonary Embolism
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


Options:
A: Inclusion Criteria:

* Informed consent
* Acute symptomatic pulmonary embolism; AND
* Deep or superficial vein thrombosis; AND
* At least one of the risk factors below :

  * More than 75 years old
  * Evolutiv cancer (excepting locally cutaneous cancer)
  * Known chronic heart failure treated
  * Chronic respiratory insufficiency treated
  * Bilateral deep vein thrombosis
  * Ilio-cava thrombosis
  * Ischemic stroke \> 3 days and \< 6 months, with lower limb deficit
  * Cardiac repercussion of pulmonary embolism assessed by echocardiography or increasing troponin I or T, or Brain Natriuretic Peptid or proBNP

Exclusion Criteria:

* Contrindication to an anticoagulant treatment or recurrent thromboembolic event despite adequate anticoagulation
* Vena cava filter already inserted
* Filter insertion impossible due to caval thrombosis
* More than 72 hours pre-randomized treatment with therapeutic dosage of anticoagulant therapy
* Non carcinologic surgery within 3 months prior randomization
* Carcinologic surgery within 10 days prior randomization
* Hypersensitivity to contrast media
* Access port in place or programmed within 3 months
* Woman who are child bearing
* Life expectancy \< 6 months
B: 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
C: Inclusion Criteria:

* Pulmonary vascular imaging positive for PE within the previous 24 hours
* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \>17 years
* Evidence of severe PE: RV hypokinesis on echocardiography, abnormal troponin I or T (any non-normal including indeterminate values, using local reference thresholds) or BNP measurement \>90 pg/mL or NT proBNP \>900 pg/ml (not more than 6 hours prior to CT angiography and not more than 30 hours before enrollment) or a pulse oximetry reading \<95% within previous two hours (\<93% in Denver).

Exclusion Criteria:

* Systolic blood pressure \< 90 mm Hg at time of informed consent
* Do not resuscitate or do not intubate order
* Systemic fibrinolytic treatment within previous 7 days
* Inability to follow-up at 3 months
* Documented gastrointestinal bleeding within previous 30 days
* Active hemorrhage in any of the following sites at the time of enrollment: intraperitoneal, retroperitoneal, pulmonary, uterine, bladder, or nose.
* Head trauma causing loss of consciousness within previous 7 days
* Any history of hemorrhagic stroke
* Ischemic stroke within the past year
* Prior history of heparin-induced thrombocytopenia
* History of intraocular hemorrhage
* Intracranial metastasis
* Known inherited bleeding disorder, e.g., hemophilia
* Platelet count \< 50,000/uL
* Prothrombin time with an INR \>1.7
* Chest, abdominal, intracranial or spinal surgery within the previous 14 days
* Subacute bacterial endocarditis
* Pregnancy (positive pregnancy test)
* Prior enrollment in the study
* Current treatment with fondiparinux, dalteparin, a direct thrombin inhibitor or administration of a glycoprotein inhibitor within the previous 48 hours.
* Known pericarditis
* Allergy to heparins,or tenecteplase
* Elapsed time that would preclude drug or placebo administration within 24 hours after diagnosis
* Evidence of non-end stage kidney injury (creatinine clearance \< 30 ml/min without chronic hemodialysis treatment; chronic hemodialysis-treated patients are eligible)
* Preexisting end-stage cardiopulmonary disease (heart failure with left ventricular ejection fraction \<20%, known severe pulmonary hypertension or other lung disease causing permanent dependence upon oxygen)
* Any other condition that the investigator believes would pose a significant hazard to the subject
D: Inclusion Criteria:

* Patients with acute PE symptoms \< 14 days.
* Filling defect by contrast-enhanced chest CT in at least one main or proximal lower lobe pulmonary artery
* Right ventricular dysfunction confirmed by echocardiography where the RV/LV end diastolic diameter ratio is ≥ 1.0.

Exclusion Criteria:

* Age less than 18 years or greater than 80 years
* Index PE symptom duration \> 14 days
* Insufficient echocardiographic image quality in the apical or subcostal four-chamber view that prohibits the measurement of the right and left ventricular end-diastolic dimensions
* Known significant bleeding risk
* Administration of thrombolytic agents, e.g., tissue plasminogen activator, streptokinase, or urokinase, within the previous 4 days
* Active bleeding
* Known bleeding diathesis
* Known coagulation disorder, platelet count \< 100 000/mm3, or previous use of vitamin K antagonists with INR \> 2.5
* History of any intracranial or intraspinal surgery or trauma or intracranial/intraspinal bleed
* Intracranial neoplasm, arteriovenous malformation, or aneurysm
* Recent (\< 3 months) GI bleeding.
* Recent (\< 3 months) internal eye surgery or hemorrhagic retinopathy; recent (\< 10 days) major surgery, cataract surgery, trauma, CPR, obstetrical delivery, or other invasive procedure.
* Allergy, hypersensitivity, or thrombocytopenia from heparin, rt-PA, or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used.
* Estimated glomerular filtration rate (eGFR) \< 50 ml/min as calculated by the Cockroft formula.
* Hemodynamic collapse at presentation defined as: need for cardiopulmonary resuscitation; or systolic blood pressure \< 90 mm Hg for at least 15 min, or drop of systolic blood pressure by at least 40 mm Hg for at least 15 min with signs of end organ hypoperfusion (cold extremities or low urinary output \< 30 mL/h or mental confusion); or need for catecholamine administration to maintain adequate organ perfusion and a systolic blood pressure of \> 90 mm Hg.
* Severe hypertension on repeated readings (systolic \> 180 mmHg or diastolic \> 105 mmHg).
* Pregnant, lactation or parturition within the previous 30 days (positive pregnancy test, women of childbearing age must be tested).
* Participating in any other investigational drug or device study.
* Life expectancy \< 90 days.
* Inability to comply with study assessments (e.g. due to geographic distance).
* Previous enrollment in this study
* Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated.
* Known right-to-left shunt, for example from large patent foramen ovale or atrial septal defect
* Large (\>10 mm) right atrial or right ventricular thrombus

Answer: B