Chronic Thromboembolic Pulmonary HypertensionETHAPENCT00657722
Identification of Criteria of the Success of the Endarterectomy in Chronic Pulmonary Post Embolic Hypertension
A study testing Angiography and Computed Tomography in people with Chronic Thromboembolic Pulmonary Hypertension, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Thromboembolic Pulmonary Hypertension
- What is being tested?
- Angiography and Computed Tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 2 sitesFrance
- Study dates
- Jan 2008to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Antoine Beclere
Clamart, 92141
Hospital Marie Lannelongue
Le Plessis-Robinson, 92350
About this study
Official title: Identification Of The Predictive Angiographic And Computed Tomographic (CT) Criteria Of The Success Of The Thromboendarterectomy In Chronic Pulmonary Hypertension
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.
Read the 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 %.
- Being tested
- Angiography and Computed Tomography
- Keywords
- Pulmonary hypertension, Chronic thromboembolic pulmonary hypertension, Operability, Thromboendarteriectomy, Operative mortality rate, Technical failure, Pulmonary angiography, Computed tomography
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiography and Computed TomographyOther
Also called standardized reading grids of APN and ASMD
Preoperative angiography and Computed Tomography
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Angiography and Computed Tomography Receives: Other: Angiography and Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical effectiveness evaluated by the death or failure rate.
Measured: 6 months
Secondary outcomes (5)
surgical effectiveness evaluated by the death or failure rate.
Measured: 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.
Measured: 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.
Measured: before surgery
Determine the incidence of adverse events associated with each of these two exams or their combination.
Measured: 3 and 6 months after surgery
Check-inter-observer reproducibility of standardized reading grids of pulmonary angiography and MD-AngioCT
Measured: Before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startJan 2008
- Primary completionJul 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Thromboembolic Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathieu LIBERATORE, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris Hôpital Antoine BéclèreDominique MUSSET, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris, Hôpital Antoine BéclèreGerald SIMONNEAU, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris, Hôpital Antoine Béclère
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00657722
- Sponsor's protocol ID
- K060205
- Acronym
- ETHAPE
- Status last verified
- Apr 2013
- First submitted
- 28 Mar 2008
- Last updated
- 11 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification Of The Predictive Angiographic And Computed Tomographic (CT) Criteria Of The Success Of The Thromboendarterectomy In Chronic Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT00657722
- Acronym / sponsor ID
- ETHAPE / K060205
- Keywords
- Pulmonary hypertension, Chronic thromboembolic pulmonary hypertension, Operability, Thromboendarteriectomy, Operative mortality rate, Technical failure, Pulmonary angiography, Computed tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 14 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 %.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Angiography and Computed TomographyAngiography and Computed Tomography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angiography and Computed TomographyAlso: standardized reading grids of APN and ASMDPreoperative angiography and Computed Tomography | Other | 1 |
Primary outcome
surgical effectiveness evaluated by the death or failure rate.
Time frame: 6 months
5 secondary outcomes
surgical effectiveness evaluated by the death or failure rate.
Time frame: 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.
Time frame: 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.
Time frame: before surgery
Determine the incidence of adverse events associated with each of these two exams or their combination.
Time frame: 3 and 6 months after surgery
Check-inter-observer reproducibility of standardized reading grids of pulmonary angiography and MD-AngioCT
Time frame: Before surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2013.
Related trials for Chronic Thromboembolic Pulmonary Hypertension
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Early Detection of CTEPH in Patients After APE
Chronic Pulmonary Thromboembolism
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The Effect of Levosimendan on Pulmonary Artery Pressure and Right Ventricular Function in the Perioperative Period in Patients With CTEPH After Pulmonary Thromboendarterectomy
LEVOSIMENDAN, PULMONARY THROMBOENDARTERECTOMY
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A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathieu LIBERATORE, MD principal investigator
Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère
Dominique MUSSET, MD, PhD study director
Assistance Publique - Hôpitaux de Paris, Hôpital Antoine Béclère
Gerald SIMONNEAU, MD, PhD study director
Assistance Publique - Hôpitaux de Paris, Hôpital Antoine Béclère
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angiography and Computed Tomography in people with Chronic Thromboembolic Pulmonary Hypertension, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgical effectiveness evaluated by the death or failure rate. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2013.