NCT02903043

Brief Summary

Limb muscle dysfunction, characterized by loss of capillaries, is amongst the most troublesome systemic consequences of chronic obstructive pulmonary disease (COPD) leading to poor functional status and premature mortality. One prevailing hypothesis stipulates that modification in the expression of miR-204 leads to change the regulation of angiogenesis in vastus lateralis of patients with COPD when compared to controls.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2015

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

May 10, 2017

Status Verified

May 1, 2017

Enrollment Period

2.2 years

First QC Date

April 9, 2015

Last Update Submit

May 9, 2017

Conditions

Keywords

MicroRNAsAngiogenesisSkeletal muscleCOPD

Outcome Measures

Primary Outcomes (1)

  • miR-204 in limb muscles in patients with COPD

    i)To measure miR-204 level in the quadriceps of patients with COPD in comparison to controls. ii) To study possible involvement of miR-204 on pathways regulating angiogenesis and on muscle microcirculation in these individuals.

    At baseline (COPD patients in a stable state of the disease)

Secondary Outcomes (1)

  • microRNAs in limb muscles of patients with COPD

    At baseline (COPD patients in a stable state of the disease)

Study Arms (2)

COPD patients

Quadriceps biopsies will be done. No drug administration.

Healthy controls

Quadriceps biopsies will be done. No drug administration.

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with COPD

You may qualify if:

  • COPD (FEV1/FVC \< 0.70)
  • Healthy subjects: no evidence of airways obstruction (FEV1/FVC \> 0.70 and FEV1 \> 0.80 predicted)
  • Smoking history \> 10 pack-years
  • Ex-smoker \>6 months

You may not qualify if:

  • Chronic hypoxemia and/or hypercapnia (PaO2 \< 60 mmHg or SpO2 \< 88% at rest and/or PaCO2 \> 45 mmHg)
  • Recent exacerbation or oral corticosteroids (\< 2 months)
  • Recent cancer (\< 3 years)
  • Diabetes
  • Myopathy, neuromuscular, neurological or articular diseases
  • Kidney disease
  • Other respiratory diseases
  • Unstable cardiac disease
  • Physical activity score \> 9 in the Voorips questionnaire
  • BMI \> 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, G1V 4G5, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample ad muscle biopsy of vastus lateralis (quadriceps)

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • François Maltais, MD

    Laval University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

April 9, 2015

First Posted

September 16, 2016

Study Start

February 1, 2013

Primary Completion

April 1, 2015

Study Completion

February 1, 2018

Last Updated

May 10, 2017

Record last verified: 2017-05

Locations