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Study on the Clinical Course Of Pulmonary Embolism (SCOPE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Raffaele Pesavento, University of Padua
ClinicalTrials.gov Identifier:
NCT01781858
First received: January 30, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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 actual incidence of symptomatic CTEPH after a first episode of acute PE;
  2. to ascertain the actual 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.


Condition
Cardiovascular Diseases
Venous Thromboembolism
Pulmonary Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study on the Clinical Course Of Pulmonary Embolism

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Padua:

Primary Outcome Measures:
  • Incidence of chronic thromboembolic pulmonary hypertension [ Time Frame: within the first 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of recurrent venous thromboembolic events [ Time Frame: whitin 5 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Incidence of all-cause mortality [ Time Frame: whitin 5 years ] [ Designated as safety issue: No ]
  • Incidence of Pulmonary Embolism - related mortality [ Time Frame: within 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 790
Study Start Date: January 2008
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
pulmonary embolism
Consecutive outpatients and inpatients with first episode of acute pulmonary embolism

Detailed Description:

All patients enrolled in the study receive 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 are treated according to current international guidelines and local protocols. All surviving patients undergo an echocardiographic examination after 6 weeks and 6 months. All surviving patients undergo a perfusional pulmonary scintigraphy at 6 months and are subsequently followed up every 6 months for at least 3 years.

In case of clinical suspicion of VTE recurrence a diagnostic procedure is 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 is 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 is graded according to a standardized scoring system by local investigators while the extension of chronic residual pulmonary embolism is graded according to a standardized scoring system by both local investigators and an independent committee. All outcome events are 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) are 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Consecutive outpatients or inpatients with an objective diagnosis of first acute PE episode.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • Age < 18 years
  • expected survival < 2 years
  • preexisting 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 of consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01781858

Sponsors and Collaborators
University of Padua
Investigators
Study Director: Raffaele Pesavento, MD University of Padua
Study Chair: Paolo Prandoni, MD,PHD University of Padua
Study Chair: Antonio Pagnan, MD University of Padua
Study Chair: Gualtiero Palareti, MD University of Bologna - Italy
Study Chair: Antonio Palla, MD University of Pisa - Italy
Study Chair: Vittorio Pengo, MD University of Padua
Study Chair: Franco Piovella, MD University of Pavia - Italy
  More Information

Publications:

Responsible Party: Raffaele Pesavento, MD, University of Padua
ClinicalTrials.gov Identifier: NCT01781858     History of Changes
Other Study ID Numbers: Scope-001
Study First Received: January 30, 2013
Last Updated: January 30, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University of Padua:
Pulmonary embolism
Chronic thromboembolic pulmonary hypertension
Venous thromboembolism

Additional relevant MeSH terms:
Cardiovascular Diseases
Embolism
Hypertension
Hypertension, Pulmonary
Pulmonary Embolism
Thromboembolism
Venous Thromboembolism
 Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases
Thrombosis

ClinicalTrials.gov processed this record on May 22, 2013