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Evolution of Pulmonary Capillary Blood Volume (VcEP)

This study is currently recruiting participants.
Verified November 2012 by Centre Hospitalier Universitaire de Saint Etienne
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00941187
First received: July 16, 2009
Last updated: November 22, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Pulmonary Embolism
 Other: diffusion NO/CO method

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evolution of Pulmonary Capillary Blood Volume (Vc) in Patients After a First Episode of Pulmonary Embolism.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
patients after a first episode of pulmonary embolism Other: diffusion NO/CO method
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%)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient with a first episode of symptomatic pulmonary embolism

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941187

Contacts
Contact: Laurent Bertoletti, MD +33(0)477828314 laurent.bertoletti@gmail.com
Contact: Carine LABRUYERE, CRA +33(0)477120469 carine.labruyere@chu-st-etienne.fr

Locations
France
Department of Medicine and Therapeutic, CHU Saint-Etienne Recruiting
Saint-etienne, France
Contact: Laurent Bertoletti, MD         laurent.bertoletti@gmail.com    
Principal Investigator: Daphné Delsart, MD            
Sub-Investigator: Nathalie Moulin, MD            
Departement of pneumology, CHU Saint-Etienne Recruiting
Saint-Etienne, France
Contact: Laurent Bertoletti, MD         laurent.bertoletti@gmail.com    
Principal Investigator: Laurent Bertoletti, MD            
Sub-Investigator: Sophie Bayle-Bleuez, MD            
Sub-Investigator: Isabelle Court-Fortune, MD            
Sub-Investigator: Frédérique Duboeuf, MD            
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Principal Investigator: Laurent BERTOLETTI, MD CHU de Saint-Etienne
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT00941187     History of Changes
Other Study ID Numbers: 0808076, 2008-A01122-53
Study First Received: July 16, 2009
Last Updated: November 22, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
pulmonary embolism
pulmonary capillary blood volume
double diffusion NO/CO method

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013