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Vascular Implications of a Naturally Occurring Asthma Exacerbation

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ClinicalTrials.gov Identifier: NCT03679299
Recruitment Status : Recruiting
First Posted : September 20, 2018
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Brief Summary:
Although asthma is a disease of the airways, research is now showing that asthmatics are more likely to develop cardiovascular disease (CVD) compared to non-asthmatics. Vascular dysfunction is seen in people at high risk of CVD and has been linked to inflammation. During an asthma attack, levels of inflammation in the whole body increase, which could potentially explain why asthmatics are at increased risk of CVD. In the proposed study the investigators will examine if asthma attacks lead to increased risk of CVD by evaluating inflammatory levels and vascular function directly following asthma attacks, 2 days and 14 days after discharge. The investigators will compare these results to non-asthmatics. The results from this study will help us understand why asthmatics are at increased risk of CVD.

Condition or disease Intervention/treatment
Asthma Inflammation Cardiovascular Risk Factor Other: Observational - No intervention

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 88 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vascular Implications of a Naturally Occurring Asthma Exacerbation
Actual Study Start Date : October 10, 2018
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort Intervention/treatment
Healthy Control
Healthy controls will be recruited from the general population and will be matched based on age, sex, and BMI. They will be assess at two time points, 48 hours apart. At each testing day, a blood sample will be taken, and endothelial function will be assessed using brachial artery flow mediated dilation. Arterial stiffness will be assessed using carotid-radial pulse wave velocity.
Other: Observational - No intervention
See outcomes

Asthma
Individuals experiencing an asthma exacerbation will be recruited from the University of Alberta Hospital Emergency Department. Once discharged, a blood sample will be taken, and endothelial function will be assessed using brachial artery flow mediated dilation. Arterial stiffness will be assessed using carotid-radial pulse wave velocity. Participants will complete the same assessments at a follow up date 48 hours and 14 days post-discharge, with the addition of a full pulmonary function test, physical activity assessment via a Fitbit, and the completion of two questionnaires: Asthma Control Questionnaire, and Asthma Quality of Life Questionnaire.
Other: Observational - No intervention
See outcomes




Primary Outcome Measures :
  1. Flow-mediated dilation [ Time Frame: Emergency Department (ED), 48 hours and 14 days post ED for asthmatics, 2 time points 48 hours apart for controls. ]
    Percent change in diameter in response to shear stress


Secondary Outcome Measures :
  1. C-reactive protein [ Time Frame: Emergency Department (ED), 48 hours and 14 days post ED for asthmatics, 2 time points 48 hours apart for controls ]
    A marker for systemic inflammation and immune response

  2. Eosinophils [ Time Frame: Emergency Department (ED), 48 hours and 14 days post ED for asthmatics, 2 time points 48 hours apart for controls ]
    A marker for systemic inflammation and immune response

  3. Neutrophils [ Time Frame: Emergency Department (ED), 48 hours and 14 days post ED for asthmatics, 2 time points 48 hours apart for controls ]
    A marker for systemic inflammation and immune response

  4. Pulse wave velocity [ Time Frame: Emergency Department (ED), 48 hours and 14 days post ED for asthmatics, 2 time points 48 hours apart for controls ]
    Carotid radial arterial stiffness


Other Outcome Measures:
  1. Average step count [ Time Frame: Fitbit worn in asthmatics for 7 days following 48 hour timepoint ]
    Physical activity measured during first 2 weeks of recovery following an asthma exacerbation


Biospecimen Retention:   Samples Without DNA
blood samples collected for analysis of serum: systemic inflammation markers


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Asthma participants recruited from the emergency department when seeking emergency care for an asthma exacerbation is the primary reason for visit.

Healthy controls recruited from the general population.

Criteria

Inclusion Criteria:

  • between the ages of 18 and 55 years old
  • waist circumference less than 88 cm for women and 102 cm for men.
  • Asthma participants will be recruited from the University of Alberta Emergency Department with asthma exacerbation as their primary reason for visit.
  • healthy controls will be recruited from the general population according to the same criteria, but with no history of asthma.

Exclusion Criteria:

  • known heart failure or unstable cardiac disease,
  • lung diseases other than asthma,
  • known chronic inflammatory condition other than asthma
  • known metabolic disease
  • current infections,
  • smoking history > 10 pack years,
  • or waist circumference >88 cm for women and >102 cm for men

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03679299


Contacts
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Contact: Shelby L Henry, BKin 780-492-8027 slhenry@ualberta.ca

Locations
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Canada, Alberta
Clinical Physiology Research Laboratory Recruiting
Edmonton, Alberta, Canada, T6G 2J1
Contact: Shelby L Henry    780-492-8027    slhenry@ualberta.ca   
Contact: Michael K Stickland    780-492-3995    michael.stickland@ualberta.ca   
University of Alberta Hospital Emergency Department Not yet recruiting
Edmonton, Alberta, Canada, T6G2B7
Contact: Shelby L Henry, BKin    780-492-8027    slhenry@ualberta.ca   
Contact: Brian H Rowe, MD, MSc    780-407-6707    brian.rowe@ualberta.ca   
Principal Investigator: Michael K Stickland, PhD         
Sub-Investigator: Cristina Villa-Roel, MD, PhD         
Sub-Investigator: Brian H Rowe, MD, MSc         
Sub-Investigator: Linn E Moore, PhD         
Sub-Investigator: Shelby L Henry, BKin         
Sub-Investigator: Desi P Fuhr, MSc         
Sub-Investigator: Mary Forhan, OTReg, PhD         
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Michael K Stickland, PhD Professor, Division of Pulmonary Medicine, Department of Medicine; Director, G.F. MacDonald Centre for Lung Health Covenant Health; Scientific Director, Respiratory Health Strategic Clinical Network, Alberta Health Services
  Study Documents (Full-Text)

Documents provided by University of Alberta:

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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT03679299     History of Changes
Other Study ID Numbers: Pro00083372
First Posted: September 20, 2018    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Alberta:
Flow-mediated dilation (FMD)
arterial stiffness
pulse wave velocity (PWV)
cardiovascular risk and asthma
endothelial function
systemic inflammation
C-reactive protein (CRP)
eosinophils
neutrophils
asthma exacerbation

Additional relevant MeSH terms:
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Asthma
Inflammation
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes