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

Primary Purpose

Chronic Thromboembolic Pulmonary Hypertension

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Angiography and Computed Tomography

About this trial

This is an interventional diagnostic trial for Chronic Thromboembolic Pulmonary Hypertension focused on measuring Pulmonary hypertension, Chronic thromboembolic pulmonary hypertension, Operability, Thromboendarteriectomy, Operative mortality rate, Technical failure, Pulmonary angiography, Computed tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Hôpital Antoine Beclere
Hospital Marie Lannelongue

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Angiography and Computed Tomography

Outcomes

Primary Outcome Measures

surgical effectiveness evaluated by the death or failure rate.

Secondary Outcome Measures

surgical effectiveness evaluated by the death or failure rate.

Check that none of the patients considered unresectable on data from staff was declared operable with the criteria predictive success of imaging examinations.

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.

Determine the incidence of adverse events associated with each of these two exams or their combination.

Check-inter-observer reproducibility of standardized reading grids of pulmonary angiography and MD-AngioCT

Full Information

NCT ID

NCT00657722

First Posted

March 28, 2008

Last Updated

April 10, 2013

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT00657722

Brief Title

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

Acronym

ETHAPE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee

5. 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.

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 %.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Thromboembolic Pulmonary Hypertension

Keywords

Pulmonary hypertension, Chronic thromboembolic pulmonary hypertension, Operability, Thromboendarteriectomy, Operative mortality rate, Technical failure, Pulmonary angiography, Computed tomography

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

N/A

Enrollment

249 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Angiography and Computed Tomography

Intervention Type

Other

Intervention Name(s)

Angiography and Computed Tomography

Other Intervention Name(s)

standardized reading grids of APN and ASMD

Intervention Description

Preoperative angiography and Computed Tomography

Primary Outcome Measure Information:

Title

surgical effectiveness evaluated by the death or failure rate.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

surgical effectiveness evaluated by the death or failure rate.

Time Frame

3 months

Title

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

Title

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

Title

Determine the incidence of adverse events associated with each of these two exams or their combination.

Time Frame

3 and 6 months after surgery

Title

Check-inter-observer reproducibility of standardized reading grids of pulmonary angiography and MD-AngioCT

Time Frame

Before surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mathieu LIBERATORE, MD

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dominique MUSSET, MD, PhD

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris, Hôpital Antoine Béclère

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Gerald SIMONNEAU, MD, PhD

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris, Hôpital Antoine Béclère

Official's Role

Study Director

Facility Information:

Facility Name

Hôpital Antoine Beclere

City

Clamart

ZIP/Postal Code

92141

Country

France

Facility Name

Hospital Marie Lannelongue

City

Le Plessis Robinson

ZIP/Postal Code

92350

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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