Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-06-21 @ 9:50 PM
Study NCT ID:
NCT03509259
Status:
UNKNOWN
Last Update Posted:
2021-10-01
First Post:
2018-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular Diseases in Elderly Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-26', 'studyFirstSubmitDate': '2018-03-29', 'studyFirstSubmitQcDate': '2018-04-16', 'lastUpdatePostDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'coronary calcium score', 'timeFrame': 'through study completion, an average of 1 month', 'description': 'coronary calcium score from coronary calcium scoring CT which, we assumed to be a surrogate marker for cardiovascular risk.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects who visited Allergy Clinic in SMG-SNU Boramae Medical Center for asthma or ACO', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* If the doctor has been diagnosed with asthma and one or more of the following criteria is met;\n\n 1. FEV1 increased more than 12% \\& 200 mL after 10-20 minutes of inhalation of short-acting bronchodilator (200-400 mg salbutamol)\n 2. Positive bronchial provocation tests (methacholine, mannitol, exercise, aspirin, etc.)\n 3. FEV1 Increased more than 12% \\& 200 mL from baseline FEV1 after anti-inflammatory treatment for 4 weeks or longer.\n\nExclusion Criteria:\n\n* Those who were already diagnosed and treated for coronary artery diseases.\n* Those with other structural lung diseases such as Tuberculosis destroyed lung and interstitial lung diseases\n* Those who are unable to conduct a test or questionnaire due to severe systemic illness, or cognitive dysfunction.\n* Those who are participating in other clinical trial using IND(investigational new drug) or finished other clinical trial within 30 days.\n* Those who refuse to participate in the study or withdraw the consent.'}, 'identificationModule': {'nctId': 'NCT03509259', 'briefTitle': 'Cardiovascular Diseases in Elderly Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Discovering Risk Factors for Cardiovascular Diseases in Elderly Asthma', 'orgStudyIdInfo': {'id': 'L-2017-313'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Asthma', 'description': 'If the doctor has been diagnosed with asthma and one or more of the following criteria is met;\n\n1. 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)\n2. Positive bronchial provocation tests (methacholine, mannitol, exercise, aspirin, etc.)\n3. FEV1 Increased more than 12% \\& 200 mL from baseline FEV1 after anti-inflammatory treatment for 4 weeks or longer.\n\nThey can have concomittent COPD or not'}, {'label': 'Healthy control', 'description': 'Subjects who performed coronary artery calcium scoring CT for health checkup purpose.(retrospective group = historical control group)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'SMG-SNU Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Min-Suk Yang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SMG-SNU Boramae Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'SMG-SNU Boramae Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}