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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014