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Cardiovascular Diseases in Elderly Asthma

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ClinicalTrials.gov Identifier: NCT03509259
Recruitment Status : Not yet recruiting
First Posted : April 26, 2018
Last Update Posted : April 26, 2018
Sponsor:
Collaborator:
SMG-SNU Boramae Medical Center
Information provided by (Responsible Party):
Seoul National University Hospital

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 and asthma-chronic obstructive pulmonary disease(COPD) overlap patients

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Discovering Risk Factors for Cardiovascular Diseases in Elderly Asthma
Estimated Study Start Date : April 30, 2018
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort
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.
Asthma-COPD overlap (ACO)
Satisfy the diagnostic criteria of asthma described above + post-bronchodilator FEV1/FVC (forced vital capacity) ratio < 70%
Healthy control
Subjects who performed coronary artery calcium scoring CT for health checkup purpose.(retrospective group = historical control group)



Primary Outcome Measures :
  1. coronary calcium score [ Time Frame: 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.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects who visited Allergy Clinic in SMG-SNU Boramae Medical Center for asthma or ACO
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03509259


Contacts
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Contact: Min-Suk Yang, MD 82-2-870-2237 iatrus13@hanmail.net

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

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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03509259     History of Changes
Other Study ID Numbers: L-2017-313
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Asthma
Cardiovascular Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases