NCT00657722

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
249

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2008

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 14, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

April 11, 2013

Status Verified

April 1, 2013

Enrollment Period

3.5 years

First QC Date

March 28, 2008

Last Update Submit

April 10, 2013

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Keywords

Pulmonary hypertensionChronic thromboembolic pulmonary hypertensionOperabilityThromboendarteriectomyOperative mortality rateTechnical failurePulmonary angiographyComputed tomography

Outcome Measures

Primary Outcomes (1)

  • surgical effectiveness evaluated by the death or failure rate.

    6 months

Secondary Outcomes (5)

  • 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

Study Arms (1)

1

EXPERIMENTAL

Angiography and Computed Tomography

Other: Angiography and Computed Tomography

Interventions

Angiography and Computed TomographyOTHER

Preoperative angiography and Computed Tomography

Also known as: standardized reading grids of APN and ASMD
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Antoine Beclere

Clamart, 92141, France

Location

Hospital Marie Lannelongue

Le Plessis-Robinson, 92350, France

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

homeobox protein PITX3

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Mathieu LIBERATORE, MD

    Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2008

First Posted

April 14, 2008

Study Start

January 1, 2008

Primary Completion

July 1, 2011

Study Completion

November 1, 2011

Last Updated

April 11, 2013

Record last verified: 2013-04

Locations

FR(2)