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CompletedNCT02035293PEPUpdated Dec 3, 2025

Frequency of Diagnostic Symptomatic Pulmonary Embolism's in Patients Hospitalized for Clinical Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

An interventional study of PEP in Chronic Obstructive Pulmonary Disease and Patients Hospitalized for a COPD Exacerbation, sponsored by University Hospital, Brest. Completed at 7 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-03.

Sponsored by University Hospital, Brest · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
750
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

A standardized diagnostic strategy of pulmonary embolism will be applied to eligible patients, incorporating a clinical probability score (revised Geneva score), plasma D-dimer assay and if necessary, a multidetector-row CT angiography thoracic and venous ultrasound of the lower limbs. All the patient with a pulmonary embolism diagnosed or not, will be followed for 3 months.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease
  • Patients Hospitalized for a COPD Exacerbation

Keywords

  • COPD Exacerbation
  • Pulmonary embolism
  • Standardized and consensus diagnostic strategy
03

In context

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's enrollment of 750 is above the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

University Hospital, Brest is the lead sponsor of 594 studies on the registry; 135 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients hospitalized for a COPD exacerbation
  • COPD previously diagnosed

Exclusion criteria

Exclusion Criteria:

  • Allergy to iodinated contrast
  • Creatinine clearance \< 30 mL / min
  • Patient hospitalized for exacerbation of COPD for more than 48 hours
  • Pneumothorax
  • Exams impossible to be performed
  • Pregnancy
  • Life expectancy \< 3 months
  • Patients already receiving anticoagulant therapy for another reason (mechanical valve, cardiac arrhythmia).
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
750 participants (actual)

Study arms

  • Other
    PEP

    No drug and no placebo were used in this study. For all the patients who participated at the study PEP, only following exams must be performed: a clinical probability score (revised Geneva score), plasma D-dimer assay and if necessary, a chest multidetector-row CT angiography and venous ultrasound of the lower limbs

    Other: PEP

Interventions

  • OtherPEP

    Also known as: No drug and no placebo were used in this study. For all the patients who participated at the study PEP, only exams must be performed;

06

What researchers measure

Primary outcomes

  1. Frequency of pulmonary embolism in patients hospitalized for a clinical exacerbation of COPD.

    Time frame: 27 months

Secondary outcomes

  1. The rate of pulmonary embolism diagnosed during the 3 month follow-up in patients whom pulmonary embolism was initially excluded when they've been included in the study

    Time frame: 27 months

07

Study locations

7 sites
  • CHU
    Angers, France
  • CHRU de Brest
    Brest, 29200, France
  • HIA
    Brest, 29240, France
  • CHU Clermont-Ferrand
    Clermont-Ferrand, 63003, France
  • Hôpital Européen Georges Pompidou
    Paris, 75015, France
  • CH de Cornouaille Quimper
    Quimper, 29107, France
  • Hôpital Nord
    Saint-Etienne, 42055, France
08

References and documents

Publications

  • Couturaud F, Bertoletti L, Pastre J, Roy PM, Le Mao R, Gagnadoux F, Paleiron N, Schmidt J, Sanchez O, De Magalhaes E, Kamara M, Hoffmann C, Bressollette L, Nonent M, Tromeur C, Salaun PY, Barillot S, Gatineau F, Mismetti P, Girard P, Lacut K, Lemarie CA, Meyer G, Leroyer C; PEP Investigators. Prevalence of Pulmonary Embolism Among Patients With COPD Hospitalized With Acutely Worsening Respiratory Symptoms. JAMA. 2021 Jan 5;325(1):59-68. doi: 10.1001/jama.2020.23567. PubMed 33399840 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02035293
Lead sponsor
University Hospital, Brest
Responsible party
Sponsor
First posted
Jan 14, 2014
Start date
Jan 8, 2014
Primary completion
Oct 13, 2017
Completion
Oct 13, 2017
Last update
Dec 3, 2025

Study contacts

Francis COUTURAUD, PU-PH
principal investigator · CHRU de Brest

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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