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CompletedNCT00941187VcEPUpdated Nov 7, 2013

Evolution of Pulmonary Capillary Blood Volume

An observational study in Pulmonary Embolism, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 2 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-11-07.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pulmonary Embolism

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Keywords

  • pulmonary embolism
  • pulmonary capillary blood volume
  • double diffusion NO/CO method
03

In context

Pulmonary Embolism

753 studies on the registry are indexed under Pulmonary Embolism; 157 are open to participants now.

This study's enrollment of 50 is below the median of 370 across 332 observational studies indexed under Pulmonary Embolism.

Browse Pulmonary Embolism studies →

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 597 studies on the registry; 127 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient with a first episode of symptomatic pulmonary embolism

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient with a first episode of symptomatic pulmonary embolism, treated with anticoagulant
  • Age from 18 to 75 years-old

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)

Groups and cohorts

  • patients after a first episode of pulmonary embolism

    Other: diffusion NO/CO method

Interventions

  • Otherdiffusion 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%)

06

What researchers measure

Primary outcomes

  1. 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

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

    Time frame: from the starting of the anticoagulant therapy to 6 months after

07

Study locations

2 sites
  • Departement of pneumology, CHU Saint-Etienne
    Saint-Etienne, France
  • Department of Medicine and Therapeutic, CHU Saint-Etienne
    Saint-Etienne, France
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2009, a primary completion of Dec 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 16, 2009
First posted
Jul 17, 2009
Start
Aug 2009
Primary completionActual
Dec 2012
CompletionActual
Dec 2012
Last update
Nov 7, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 7, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00941187
Responsible party
Sponsor
First posted
Jul 17, 2009
Start date
Aug 2009
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Nov 7, 2013

Study contacts

Laurent BERTOLETTI, MD
principal investigator · CHU de Saint-Etienne

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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