Evolution of Pulmonary Capillary Blood Volume (VcEP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00941187
First received: July 16, 2009
Last updated: November 6, 2013
Last verified: November 2013
  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:


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 ]

Enrollment: 50
Study Start Date: August 2009
Study Completion Date: December 2012
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

Locations
France
Department of Medicine and Therapeutic, CHU Saint-Etienne
Saint-etienne, France
Departement of pneumology, CHU Saint-Etienne
Saint-Etienne, France
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 6, 2013
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 April 17, 2014