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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00657722
First received: March 28, 2008
Last updated: April 10, 2013
Last verified: April 2013

March 28, 2008
April 10, 2013
January 2008
July 2011   (final data collection date for primary outcome measure)
surgical effectiveness evaluated by the death or failure rate. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00657722 on ClinicalTrials.gov Archive Site
  • surgical effectiveness evaluated by the death or failure rate. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Determine the incidence of adverse events associated with each of these two exams or their combination. [ Time Frame: 3 and 6 months after surgery ] [ Designated as safety issue: Yes ]
  • Check-inter-observer reproducibility of standardized reading grids of pulmonary angiography and MD-AngioCT [ Time Frame: Before surgery ] [ Designated as safety issue: No ]
  • surgical effectiveness evaluated by the death or failure rate. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Determine the square of the NPC in the balance usability compared with the ASMD comparing one hand, the decision to read standardized operability of the AMD-64 cuts with that of the NPC and with that of the association of two exams [ Time Frame: before surgery ] [ Designated as safety issue: No ]
  • Determine the incidence of adverse events associated with each of these two exams or their combination. [ Time Frame: 3 and 6 months after surgery ] [ Designated as safety issue: Yes ]
  • Check-inter-observer reproducibility of standardized reading grids of APN and ASMD [ Time Frame: Before surgery ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Identification of Criteria of the Success of the Endarterectomy in Chronic Pulmonary Post Embolic Hypertension
Identification Of The Predictive Angiographic And Computed Tomographic (CT) Criteria Of The Success Of The Thromboendarterectomy In Chronic Pulmonary Hypertension

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.

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 %.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Chronic Thromboembolic Pulmonary Hypertension
Other: Angiography and Computed Tomography
Preoperative angiography and Computed Tomography
Other Name: standardized reading grids of APN and ASMD
Experimental: 1
Angiography and Computed Tomography
Intervention: Other: Angiography and Computed Tomography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
249
November 2011
July 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00657722
K060205
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
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
Assistance Publique - Hôpitaux de Paris
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP