Identification of Criteria of the Success of the Endarterectomy in Chronic Pulmonary Post Embolic Hypertension
- Conditions
- Chronic Thromboembolic Pulmonary Hypertension
- Interventions
- Other: Angiography and Computed Tomography
- Registration Number
- NCT00657722
- Lead Sponsor
- Assistance Publique - H么pitaux 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.
- 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 %.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 249
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Angiography and Computed Tomography Angiography and Computed Tomography
- Primary Outcome Measures
Name Time Method surgical effectiveness evaluated by the death or failure rate. 6 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
H么pital Antoine Beclere
馃嚝馃嚪Clamart, France
Hospital Marie Lannelongue
馃嚝馃嚪Le Plessis Robinson, France