Evolution of Pulmonary Capillary Blood Volume
VcEP
2 other identifiers
observational
50
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2009
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2009
CompletedFirst Posted
Study publicly available on registry
July 17, 2009
CompletedStudy Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedNovember 7, 2013
November 1, 2013
3.3 years
July 16, 2009
November 6, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
difference of pulmonary capillary blood volume (Vc) from J0 to 6 months
from the starting of the anticoagulant therapy to 6 months after
Secondary Outcomes (1)
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
from the starting of the anticoagulant therapy to 6 months after
Study Arms (1)
patients after a first episode of pulmonary embolism
Interventions
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 Criteria
Patient with a first episode of symptomatic pulmonary embolism
You may qualify if:
- Patient with a first episode of symptomatic pulmonary embolism, treated with anticoagulant
- Age from 18 to 75 years-old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Departement of pneumology, CHU Saint-Etienne
Saint-Etienne, France
Department of Medicine and Therapeutic, CHU Saint-Etienne
Saint-Etienne, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laurent BERTOLETTI, MD
CHU de Saint-Etienne
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2009
First Posted
July 17, 2009
Study Start
August 1, 2009
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
November 7, 2013
Record last verified: 2013-11