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Identification of Criteria of the Success of the Endarterectomy in Chronic Pulmonary Post Embolic Hypertension (ETHAPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00657722
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : April 11, 2013
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
In order to improve effectiveness of the surgical operation thanks to a reduction in the rate of failure, this study will allow us to identify predictive angiographic and CT finding of surgical failure, starting from standardized reading grids, in order to have a better selection of the operable patients.

Condition or disease Intervention/treatment Phase
Chronic Thromboembolic Pulmonary Hypertension Other: Angiography and Computed Tomography Not Applicable

Detailed Description:

Chronic thromboembolic pulmonary hypertension(CTEPH) is caused by obstruction of the large pulmonary arteries by acute and recurrent pulmonary emboli, and organization of these blood clots. ANTOINE BECLERE respiratory unit, in partnership with the MARIE LANNELONGUE hospital thoracic and vascular surgery departments was designated recently as reference national centre for pulmonary hypertension and represents the only French structure for evaluation of CTEPH with 150 patients addressed each year.If the disease is proximately located, CTEPH can be cured surgically through a complex surgical procedure performed under Hypothermia and total circulatory arrest. In spite of multidisciplinary meeting deciding the operability of each case the rate of failure is approximately of 15% (9% of operative mortality rate and 6% of technical failure).

The aim of this study is to identify predictive angiographic and CT findings of success, by allowing a better selection of operable patients.

It would be possible to improve the effectiveness of the surgical treatment and reduce the rate failure from 15% to 7 % or even 5 %.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 249 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Identification Of The Predictive Angiographic And Computed Tomographic (CT) Criteria Of The Success Of The Thromboendarterectomy In Chronic Pulmonary Hypertension
Study Start Date : January 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : November 2011

Arm Intervention/treatment
Experimental: 1
Angiography and Computed Tomography
Other: Angiography and Computed Tomography
Preoperative angiography and Computed Tomography
Other Name: standardized reading grids of APN and ASMD

Primary Outcome Measures :
  1. surgical effectiveness evaluated by the death or failure rate. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. surgical effectiveness evaluated by the death or failure rate. [ Time Frame: 3 months ]
  2. Check that none of the patients considered unresectable on data from staff was declared operable with the criteria predictive success of imaging examinations. [ Time Frame: before surgery ]
  3. Determine the interest of pulmonary angiography in the operability decision compared first to Multi detector AngioCT alone with standardized analyze and then with the both exams. [ Time Frame: before surgery ]
  4. Determine the incidence of adverse events associated with each of these two exams or their combination. [ Time Frame: 3 and 6 months after surgery ]
  5. Check-inter-observer reproducibility of standardized reading grids of pulmonary angiography and MD-AngioCT [ Time Frame: Before surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients addressed to the reference centre of pulmonary hypertension for a suspected CPC-PE
  • Achieving an assessment prior to the operation, including:1) Right cardiac catheterization confirming HTP with a mean pulmonary arterial pressure> 25 mm Hg at rest; 2) Echography and Doppler of the lower limbs in search of phlebitis sequela; 3) Pulmonary scintigraphy with 6 views in ventilation and perfusion; 4) Digital pulmonary angiography; 5) A 64 detector pulmonary computed tomography; 6) Having read the briefing note and given their agreement.

Exclusion criteria:

  • Refusal examinations .
  • Patient for which one method is contraindicated
  • Patient considered not operable by the staff
  • Life expectancy of less than 3 months
  • Geographical distance for the clinical follow-up at 3 months
  • Renal insufficiency (creatinine clearance <30 mL / min)
  • Proven allergy to iodinated contrast agents
  • Pregnant woman.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00657722

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Hôpital Antoine Beclere
Clamart, France, 92141
Hospital Marie Lannelongue
Le Plessis Robinson, France, 92350
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Principal Investigator: Mathieu LIBERATORE, MD Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère
Study Director: Dominique MUSSET, MD, PhD Assistance Publique - Hôpitaux de Paris, Hôpital Antoine Béclère
Study Director: Gerald SIMONNEAU, MD, PhD Assistance Publique - Hôpitaux de Paris, Hôpital Antoine Béclère

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Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT00657722    
Other Study ID Numbers: K060205
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: April 2013
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Pulmonary hypertension
Chronic thromboembolic pulmonary hypertension
Operative mortality rate
Technical failure
Pulmonary angiography
Computed tomography
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases