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

Chronic Thromboembolic Pulmonary Hypertension Clinical Trial

— ETHAPE  

Official title:

Identification Of The Predictive Angiographic And Computed Tomographic (CT) Criteria Of The Success Of The Thromboendarterectomy In Chronic Pulmonary Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00657722
• Other study ID #: K060205
• Status: Completed
• Phase: N/A
• First received: March 28, 2008
• Last updated: April 10, 2013
• Start date: January 2008
• Est. completion date: November 2011

Study information

• Verified date: April 2013
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: November 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Thromboembolic Pulmonary Hypertension
• Hypertension
• Hypertension, Pulmonary

Intervention

Other:
• Angiography and Computed Tomography
Preoperative angiography and Computed Tomography

Locations

Country	Name	City	State
France	Hôpital Antoine Beclere	Clamart
France	Hospital Marie Lannelongue	Le Plessis Robinson

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	surgical effectiveness evaluated by the death or failure rate.		6 months	Yes
Secondary	surgical effectiveness evaluated by the death or failure rate.		3 months	Yes
Secondary	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	No
Secondary	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	No
Secondary	Determine the incidence of adverse events associated with each of these two exams or their combination.		3 and 6 months after surgery	Yes
Secondary	Check-inter-observer reproducibility of standardized reading grids of pulmonary angiography and MD-AngioCT		Before surgery	No