Expression of miR-204 and Consequences on Capillarization in Limb Muscles of Patients With COPD
1 other identifier
observational
100
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2013
Longer than P75 for all trials
1 active site
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
Study Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 9, 2015
CompletedFirst Posted
Study publicly available on registry
September 16, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedMay 10, 2017
May 1, 2017
2.2 years
April 9, 2015
May 9, 2017
Conditions
Keywords
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
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
- Laval Universitylead
- Canadian Institutes of Health Research (CIHR)collaborator
Study Sites (1)
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, G1V 4G5, Canada
Biospecimen
Blood sample ad muscle biopsy of vastus lateralis (quadriceps)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
François Maltais, MD
Laval University
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