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

July 16, 2009
November 6, 2013
August 2009
December 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00941187 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Evolution of Pulmonary Capillary Blood Volume
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patient with a first episode of symptomatic pulmonary embolism

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%)
patients after a first episode of pulmonary embolism
Intervention: Other: diffusion NO/CO method
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00941187
0808076, 2008-A01122-53
No
Centre Hospitalier Universitaire de Saint Etienne
Centre Hospitalier Universitaire de Saint Etienne
Not Provided
Principal Investigator: Laurent BERTOLETTI, MD CHU de Saint-Etienne
Centre Hospitalier Universitaire de Saint Etienne
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP