Please select the eligibility criteria that correspond to the clinical trial below.
Title: Study on the Clinical Course Of Pulmonary Embolism
Brief Summary: The course of both pulmonary embolism (PE) and one of its more relevant late complications, i.e. chronic thromboembolic pulmonary hypertension (CTEPH) is still substantially unknown.

Recent evidence has shown that the incidence of CTEPH is higher than previously believed, but this has not been confirmed by other studies. A clear link between PE and CTEPH has been questioned by some experts. A great number of patients affected by PE persistently have residual chronic thromboembolic material the meaning of which is a matter of debate. The evidence sustaining a link between chronic residual PE and subsequent PE recurrences or CTEPH is insufficient.

Thus, a nationwide, multicentre, prospective cohort study was designed with the following aims:

1. to ascertain the incidence of symptomatic CTEPH after a first episode of acute PE;
2. to ascertain the incidence of venous thromboembolic (VTE) recurrences after a first episode of acute PE;
3. to evaluate whether a relation exists between chronic residual PE and CTEPH
4. to evaluate whether a relation exists between chronic residual PE and VTE recurrences;
5. to evaluate whether a relation exists between persistent right ventricular dysfunction and CTEPH;
6. to evaluate whether a relation exists between persistent right ventricular dysfunction and PE recurrences.

For each enrolling centre, consecutive outpatients or inpatients with an objectively diagnosed first acute PE episode are considered eligible.


Options:
A: Inclusion Criteria:

* age between 18 and 85;
* symptomatic PE confirmed by: high probability lung scan, or intermediate probability lung scan and objectively confirmed deep vein thrombosis, or spiral CT-scan or pulmonary angiography or TE echocardiography;
* normal blood pressure (SBP \>100mmHg);
* RVD at echocardiography (see criteria);
* written informed consent.

Exclusion Criteria:

* absence of RVD at echocardiography;
* shock or hypotension (SBP \< 100 mmHg);
* therapeutic heparin (UFH or LMWH) treatment for more than 48 hours prior to randomization;
* administration of thrombolytic agents within the previous 4 days;
* vena cava filter insertion or pulmonary thrombectomy within the previous 4 days
* chronic pulmonary hypertension or severe COPD;
* hypertension defined as blood pressure \>180/110 mm Hg (systolic BP \>180 mm Hg and/or diastolic BP \>110 mm Hg) on a single, reliable measurement during current admission at enrolling site prior to randomisation;
* use of GP IIb/IIIa antagonists within the preceding 7 days;
* significant bleeding disorders either at present or within the past 6 months;
* active peptic ulceration;
* known diabetic haemorrhagic retinopathy or other haemorrhagic ophthalmic conditions;
* known haemorrhagic diathesis;
* known arterial aneurysm and known arterial/venous malformation;
* known neoplasm with increased bleeding risk;
* prolonged cardiopulmonary resuscitation (\>10 minutes) in the previous two weeks;
* current oral anticoagulation;
* major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months;
* any known history of stroke or transient ischaemic attack (TIA) or dementia;
* any recent head trauma and any other trauma occurring after onset of the current pulmonary embolism;
* any known history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery);
* known subacute bacterial endocarditis;
* known acute pancreatitis;
* known severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension
* (oesophageal varices) and active hepatitis;
* pregnancy or lactation or parturition within the previous 30 days;
* women of childbearing potential must have a negative pregnancy test, or use a medically accepted method of birth control;
* treatment with an investigational drug under another study protocol in the past 7 days;
* previous enrolment in this study;
* known hypersensitivity to Tenecteplase, Alteplase, unfractionated heparin, or to any of the excipients;
* anticipated or obvious problem with vascular access;
* any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated;
* inability to follow protocol requirements
B: Inclusion Criteria:

* Consecutive Outpatients/Inpatients with acute first episode of acute pulmonary embolism

Exclusion Criteria:

* Pregnancy
* Age \< 18 years
* expected survival \< 2 years
* previous episodes of VTE
* need for anticoagulation for reasons other than VTE
* preexisting severe cardiac or pulmonary diseases
* preexisting diseases that could cause non thromboembolic pulmonary hypertension
* Patients geographically inaccessible for follow up
* Low compliance to anticoagulant therapy and planned diagnostic work-up
* Refusal to give written informed consent
C: Inclusion Criteria:

* Symptomatic proximal DVT involving the iliac, common femoral, and/or femoral vein.

Exclusion Criteria:

* Age less than 16 years or greater than 75 years.
* Symptom duration \> 14 days for the DVT episode in the index leg (i.e., non-acute DVT).
* In the index leg: established PTS, or previous symptomatic DVT within the last 2 years.
* In the contralateral (non-index) leg: symptomatic acute DVT a) involving the iliac and/or common femoral vein; or b) for which thrombolysis is planned as part of the initial therapy.
* Limb-threatening circulatory compromise.
* Pulmonary embolism with hemodynamic compromise (i.e., hypotension).
* Inability to tolerate PCDT procedure due to severe dyspnea or acute systemic illness.
* 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.
* Hemoglobin \< 9.0 mg/dl, INR \> 1.6 before warfarin was started, or platelets \< 100,000/ml.
* Moderate renal impairment in diabetic patients (estimated glomerular filtration rate \[GFR\] \< 60 ml/min) or severe renal impairment in non-diabetic patients (estimated GFR \< 30 ml/min).
* Active bleeding, recent (\< 3 mo) GI bleeding, severe liver dysfunction, bleeding diathesis.
* Recent (\< 3 mo) internal eye surgery or hemorrhagic retinopathy; recent (\< 10 days) major surgery, cataract surgery, trauma, cardiopulmonary resuscitation, obstetrical delivery, or other invasive procedure.
* History of stroke or intracranial/intraspinal bleed, tumor, vascular malformation, aneurysm.
* Active cancer (metastatic, progressive, or treated within the last 6 months). Exception: patients with non-melanoma primary skin cancers are eligible to participate in the study.
* Severe hypertension on repeated readings (systolic \> 180 mmHg or diastolic \> 105 mmHg).
* Pregnant (positive pregnancy test, women of childbearing potential must be tested).
* Recently (\< 1 mo) had thrombolysis or is participating in another investigational drug study.
* Use of a thienopyridine antiplatelet drug (except clopidogrel) in the last 5 days.
* Life expectancy \< 2 years or chronic non-ambulatory status.
* Inability to provide informed consent or to comply with study assessments (e.g. due to cognitive impairment or geographic distance).
D: Inclusion Criteria:

* Age 18 years or older
* Acute PE (first symptoms occurring 15 days or less before randomisation) confirmed by lung scan, or a positive spiral computed tomogram, or a positive pulmonary angiogram
* Right ventricular dysfunction confirmed by echocardiography or spiral computed tomography of the chest and a positive troponin I or T test

Exclusion criteria:

* Haemodynamic collapse at presentation as defined above
* Known significant bleeding risk
* Administration of thrombolytic agents within the previous 4 days
* Vena cava filter insertion or pulmonary thrombectomy within the previous 4 days
* Uncontrolled hypertension defined as systolic BP \>180 mm Hg and/or diastolic BP \>110 mm Hg at randomisation
* Treatment with an investigational drug under another study protocol in the previous 7 days or greater, according to local requirements
* Previous enrolment in this study
* Known hypersensitivity to tenecteplase, alteplase, unfractionated heparin, or to any of the excipients
* Pregnancy, lactation or parturition within the previous 30 days. Women of childbearing age must have a negative pregnancy test or use a medically accepted method of birth control
* Known coagulation disorder (including vitamin K antagonists)
* Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated

Answer: B