Cardiovascular Diseases in Elderly Asthma

NCT03509259 | Unknown DMC

• 1 other identifier: L-2017-313
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Asthma

If the doctor has been diagnosed with asthma and one or more of the following criteria is met; 1. 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) 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. 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)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• If the doctor has been diagnosed with asthma and one or more of the following criteria is met;
• FEV1 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead
• SMG-SNU Boramae Medical Center: collaborator

Study Sites (1)

SMG-SNU Boramae Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Min-Suk Yang, MD

  SMG-SNU Boramae Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 26, 2018
• Study Start: March 21, 2019
• Primary Completion: March 12, 2021
• Study Completion: December 30, 2023
• Last Updated: October 1, 2021

Record last verified: 2021-03

Locations

KR (1)