Cardiovascular Diseases in Elderly Asthma

NCT ID: NCT03509259

Last Updated: 2021-10-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 72 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-21
• Study Completion Date: 2023-12-30

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

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.

Conditions

Asthma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Healthy control

Subjects who performed coronary artery calcium scoring CT for health checkup purpose.(retrospective group = historical control group)

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SMG-SNU Boramae Medical Center

OTHER

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Min-Suk Yang, MD

Role: PRINCIPAL_INVESTIGATOR

SMG-SNU Boramae Medical Center

Locations

SMG-SNU Boramae Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

L-2017-313

Identifier Type: -

Identifier Source: org_study_id