Cardiovascular Diseases in Elderly Asthma

Sponsor
Seoul National University Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03509259
Collaborator
SMG-SNU Boramae Medical Center (Other)
72
1
57.3
1.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    72 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Discovering Risk Factors for Cardiovascular Diseases in Elderly Asthma
    Actual Study Start Date :
    Mar 21, 2019
    Actual Primary Completion Date :
    Mar 12, 2021
    Anticipated Study Completion Date :
    Dec 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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)

    Outcome Measures

    Primary Outcome Measures

    1. coronary calcium score [through study completion, an average of 1 month]

      coronary calcium score from coronary calcium scoring CT which, we assumed to be a surrogate marker for cardiovascular risk.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 SMG-SNU Boramae Medical Center Seoul Korea, Republic of

    Sponsors and Collaborators

    • Seoul National University Hospital
    • SMG-SNU Boramae Medical Center

    Investigators

    • Principal Investigator: Min-Suk Yang, MD, SMG-SNU Boramae Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT03509259
    Other Study ID Numbers:
    • L-2017-313
    First Posted:
    Apr 26, 2018
    Last Update Posted:
    Oct 1, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 1, 2021