Evolution of Pulmonary Capillary Blood Volume

Pulmonary Embolism Clinical Trial

— VcEP  

Official title:

Evolution of Pulmonary Capillary Blood Volume (Vc) in Patients After a First Episode of Pulmonary Embolism.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00941187
• Other study ID #: 0808076
• Secondary ID: 2008-A01122-53
• Status: Completed
• Phase: N/A
• First received: July 16, 2009
• Last updated: November 6, 2013
• Start date: August 2009
• Est. completion date: December 2012

Study information

• Verified date: November 2013
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection Authority
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

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%)

Locations

Country	Name	City	State
France	Departement of pneumology, CHU Saint-Etienne	Saint-Etienne
France	Department of Medicine and Therapeutic, CHU Saint-Etienne	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference of pulmonary capillary blood volume (Vc) from J0 to 6 months		from the starting of the anticoagulant therapy to 6 months after	No
Secondary	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	No