Vascular Implications of a Naturally Occurring Asthma Exacerbation

NCT03679299 | Terminated

• 1 other identifier: Pro00083372
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 2

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.

Conditions

Asthma; Inflammation; Cardiovascular Risk Factor

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Flow-mediated dilation

  Percent change in diameter in response to shear stress

  Emergency Department (ED), 48 hours and 14 days post ED for asthmatics, 2 time points 48 hours apart for controls.

Secondary Outcomes (4)

• C-reactive protein

  Emergency Department (ED), 48 hours and 14 days post ED for asthmatics, 2 time points 48 hours apart for controls

• Eosinophils

  Emergency Department (ED), 48 hours and 14 days post ED for asthmatics, 2 time points 48 hours apart for controls

• Neutrophils

  Emergency Department (ED), 48 hours and 14 days post ED for asthmatics, 2 time points 48 hours apart for controls

• Pulse wave velocity

  Emergency Department (ED), 48 hours and 14 days post ED for asthmatics, 2 time points 48 hours apart for controls

Other Outcomes (1)

• Average step count

  Fitbit worn in asthmatics for 7 days following 48 hour timepoint

Study Arms (2)

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

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

Interventions

Observational - No intervention OTHER

See outcomes

Asthma; Healthy Control

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (2)

University of Alberta Hospital Emergency Department

Edmonton, Alberta, T6G2B7, Canada

Location

Desi Fuhr

Edmonton, Alberta, T6W2Z2, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples collected for analysis of serum: systemic inflammation markers

MeSH Terms

Conditions

Asthma; Inflammation

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: September 20, 2018
• Study Start: October 10, 2018
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)