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
  Purpose

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 Intervention
Chronic Thromboembolic Pulmonary Hypertension
Other: Angiography and Computed Tomography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • surgical effectiveness evaluated by the death or failure rate. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 249
Study Start Date: January 2008
Study Completion Date: November 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Angiography and Computed Tomography
Other: Angiography and Computed Tomography
Preoperative angiography and Computed Tomography
Other Name: standardized reading grids of APN and ASMD

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 %.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00657722

Locations
France
Hôpital Antoine Beclere
Clamart, France, 92141
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
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00657722     History of Changes
Other Study ID Numbers: K060205
Study First Received: March 28, 2008
Last Updated: April 10, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Pulmonary hypertension
Chronic thromboembolic pulmonary hypertension
Operability
Thromboendarteriectomy
Operative mortality rate
Technical failure
Pulmonary angiography
Computed tomography

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 26, 2014