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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT00657722

Collaborator

(none)

249

Enrollment

Locations

Arm

Duration (Months)

124.5

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 %.

Study Design

Study Type:

Interventional

Actual Enrollment :

249 participants

Allocation:

N/A

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 :

Jan 1, 2008

Actual Primary Completion Date :

Jul 1, 2011

Actual Study Completion Date :

Nov 1, 2011

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1

Angiography and Computed Tomography

Other: Angiography and Computed Tomography

Preoperative angiography and Computed Tomography

Other Names:

standardized reading grids of APN and ASMD

Outcome Measures

Primary Outcome Measures

surgical effectiveness evaluated by the death or failure rate. [6 months]

Secondary Outcome Measures

surgical effectiveness evaluated by the death or failure rate. [3 months]
Check that none of the patients considered unresectable on data from staff was declared operable with the criteria predictive success of imaging examinations. [before surgery]
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. [before surgery]
Determine the incidence of adverse events associated with each of these two exams or their combination. [3 and 6 months after surgery]
Check-inter-observer reproducibility of standardized reading grids of pulmonary angiography and MD-AngioCT [Before surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Antoine Beclere	Clamart		France	92141
2	Hospital Marie Lannelongue	Le Plessis Robinson		France	92350

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

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