Study on the Clinical Course Of Pulmonary Embolism

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.

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Key information

Conditions

Cardiovascular Diseases Embolism Embolism and Thrombosis Hypertension Hypertension, Pulmonary Lung Diseases Pulmonary Embolism Pulmonary Hypertension Respiratory Tract Diseases Thromboembolism Vascular Diseases Venous Thromboembolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

All patients enrolled in the study received a diagnosis of PE by means of chest CT scan, lung scanning or pulmonary angiography. All patients should undergo an echocardiographic examination during the acute phase of PE, when this is possible. All patients will be treated according to current international guidelines and local protocols. All surviving patients will receive an echocardiographic examination after 6 weeks and 6 months. All surviving patients will receive a perfusional pulmonary scintigraphy at 6 months and be subsequently followed up every 6 months for at least 3 years.

In case of clinical suspicion of VTE recurrence a diagnostic procedure will be performed in order to confirm the recurrent VTE episode ( Chest CT scan, lung scan, Pulmonary angiography, compressive ultrasound, phlebography, vein CT scan).

In case of clinical suspicion of CTEPH, a further diagnostic workup will be performed, consisting in echocardiography, ventilation/perfusion lung scanning, multidetector chest CT scanning, and pulmonary angiography, with direct measurement of the pulmonary-artery pressure.

The extension of pulmonary embolism during the acute phase will be graded according to a standardized scoring system by local investigators while the extension of chronic residual pulmonary embolism will be graded according to a standardized scoring system ( Meyer score) by both local investigators and an independent committee. All outcome events will be centrally adjudicated by an independent committee.

All clinical data ( initial data on medical history, clinical symptoms, presence of risk factors, diagnoses, diagnostic tests results, treatment type and duration, outcome events and other) will be collected by the local investigators in an electronic medical database. Related data will be sent to the coordinating centre on a regular basis. All recruiting centres will be regularly monitored by the coordinating Centre.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Incidence of chronic thromboembolic pulmonary hypertension

Time frame: within 3 years

Secondary outcomes

Incidence of recurrent venous thromboembolic events

Time frame: within 3 years

Other outcomes

Incidence of all-cause mortality

Time frame: within 3 years
Incidence of Pulmonary Embolism - related mortality

Time frame: within 3 years

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Acronym: SCOPE

Important dates

Study start: 2008
Primary completion: 2014
Study completion: 2014
First posted: Feb 1, 2013
Registry last updated: Jun 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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