Cardiovascular Diseases in Elderly Asthma

Discovering Risk Factors for Cardiovascular Diseases in Elderly Asthma

This study is a cross-sectional study to evaluate the relationship between coronary calcium score and clinical parameters of asthma such as onset of disease, lung function parameter and airway inflammation parameter (sputum eosinophil or FeNO) in Korean elderly asthma (regardless of whether they have concomittent COPD or not) patients

Study Overview

• Status: Active, not recruiting
• Conditions: Asthma

Detailed Description

Subjects who visited Allergy Clinic in SMG-SNU Boramae Medical Center for asthma or ACO will be recruited consecutively. Subjects who meets the inclusion criteria and agree to participate in the study will take coronary artery calcium scoring CT and asthma CT (inspiration and expiration images). The correlation between the degree of coronary calcification and airway diameter, airway wall thickness, air-trapping and emphysema will be evaluated as well as clinical parameters of asthma. We will also compare those correlations from the images of healthy control subjects who performed the coronary calcium scoring CT for health checkup purpose.

• Study Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • SMG-SNU Boramae Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects who visited Allergy Clinic in SMG-SNU Boramae Medical Center for asthma or ACO

Description

Inclusion Criteria:

• If the doctor has been diagnosed with asthma and one or more of the following criteria is met;

  1. FEV1 increased more than 12% & 200 mL after 10-20 minutes of inhalation of short-acting bronchodilator (200-400 mg salbutamol)
  2. Positive bronchial provocation tests (methacholine, mannitol, exercise, aspirin, etc.)
  3. FEV1 Increased more than 12% & 200 mL from baseline FEV1 after anti-inflammatory treatment for 4 weeks or longer.

Exclusion Criteria:

• Those who were already diagnosed and treated for coronary artery diseases.
• Those with other structural lung diseases such as Tuberculosis destroyed lung and interstitial lung diseases
• Those who are unable to conduct a test or questionnaire due to severe systemic illness, or cognitive dysfunction.
• Those who are participating in other clinical trial using IND(investigational new drug) or finished other clinical trial within 30 days.
• Those who refuse to participate in the study or withdraw the consent.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Asthma; If the doctor has been diagnosed with asthma and one or more of the following criteria is met; FEV1 (Forced expiratory volume in 1 second) increased more than 12% & 200 mL after 10-20 minutes of inhalation of short-acting bronchodilator (200-400 mg salbutamol); Positive bronchial provocation tests (methacholine, mannitol, exercise, aspirin, etc.); FEV1 Increased more than 12% & 200 mL from baseline FEV1 after anti-inflammatory treatment for 4 weeks or longer. They can have concomittent COPD or not
Healthy control; Subjects who performed coronary artery calcium scoring CT for health checkup purpose.(retrospective group = historical control group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
coronary calcium score	coronary calcium score from coronary calcium scoring CT which, we assumed to be a surrogate marker for cardiovascular risk.	through study completion, an average of 1 month

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: SMG-SNU Boramae Medical Center
• Investigators: Principal Investigator: Min-Suk Yang, MD, SMG-SNU Boramae Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 21, 2019
• Primary Completion (ACTUAL): March 12, 2021
• Study Completion (ANTICIPATED): December 30, 2023

Study Registration Dates

• First Submitted: March 29, 2018
• First Submitted That Met QC Criteria: April 16, 2018
• First Posted (ACTUAL): April 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 26, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Cardiovascular Diseases; Asthma
• Other Study ID Numbers: L-2017-313

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No