- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00941187
Evolution of Pulmonary Capillary Blood Volume (VcEP)
November 6, 2013 updated by: Centre Hospitalier Universitaire de Saint Etienne
Evolution of Pulmonary Capillary Blood Volume (Vc) in Patients After a First Episode of Pulmonary Embolism.
The purpose of this monocentric, preliminary study is to assess the evolution of pulmonary capillary blood volume (Vc), measured by the double diffusion nitric oxide/carbon monoxide (NO/CO) method (Guenard et al.; Respir Physiol 1987), from the starting of the anticoagulant therapy to 6 months after, and to search correlations with the evolution of clinical (dyspnea and results of the 6 minutes walking test), biological (BNP; Troponin), echocardiographic (right ventricular dysfunction, pulmonary arterial pressure) and ventilation/perfusion lung scan data.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Saint-Etienne, France
- Departement of pneumology, CHU Saint-Etienne
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Saint-etienne, France
- Department of Medicine and Therapeutic, CHU Saint-Etienne
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patient with a first episode of symptomatic pulmonary embolism
Description
Inclusion Criteria:
- Patient with a first episode of symptomatic pulmonary embolism, treated with anticoagulant
- Age from 18 to 75 years-old
Exclusion Criteria:
- Confirmed pulmonary embolism in the past
- Massive pulmonary embolism, thrombolytic treatment
- Confirmed left heart systolic dysfunction
- Confirmed asthma, chronic obstructive pulmonary disease or pulmonary fibrosis
- Expected life below 6 months
- Pleural effusion with indication of evacuation
- Bronchopulmonary cancer
- Pulmonary surgery with resection of two lobes minimum
- Predictable incapacity to complete the 6 minutes walking test
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
patients after a first episode of pulmonary embolism
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pulmonary capillary blood volume (Vc), measured by the double diffusion NO/CO method: this method is to inhale during a deep inspiration with a mixture of helium (8-10%), CO (2000 ppm) and NO (20-40 ppm), the O2 (21%)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
difference of pulmonary capillary blood volume (Vc) from J0 to 6 months
Time Frame: from the starting of the anticoagulant therapy to 6 months after
|
from the starting of the anticoagulant therapy to 6 months after
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
correlations with the evolution of clinical (dyspnea and results of the 6 minutes walking test), biological (BNP; Troponin), echocardiographic (right ventricular dysfunction, pulmonary arterial pressure) and ventilation/perfusion lung scan data
Time Frame: from the starting of the anticoagulant therapy to 6 months after
|
from the starting of the anticoagulant therapy to 6 months after
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Laurent BERTOLETTI, MD, Chu de Saint-Etienne
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
July 16, 2009
First Submitted That Met QC Criteria
July 16, 2009
First Posted (Estimate)
July 17, 2009
Study Record Updates
Last Update Posted (Estimate)
November 7, 2013
Last Update Submitted That Met QC Criteria
November 6, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0808076
- 2008-A01122-53 (Other Identifier: AFSSAPS)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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