Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT06076551
Status:
RECRUITING
Last Update Posted:
2025-03-26
First Post:
2023-09-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sex Difference of Coronary Microvascular Dysfunction in Patients With Non-obstructive Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017566', 'term': 'Microvascular Angina'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2023-09-25', 'studyFirstSubmitQcDate': '2023-10-06', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A composite outcome including all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for heart failure', 'timeFrame': '1 year', 'description': 'Number of participants with a composite outcome including all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for heart failure'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Microvascular Angina']}, 'descriptionModule': {'briefSummary': 'Sex difference of coronary microvascular dysfunction evaluated by coronary flow reserve will be assessed in patients with non-obstructive coronary artery disease', 'detailedDescription': 'The investigators will select consecutive patients who experienced chest pain but had no significant coronary artery stenosis (\\<50% stenosis). Coronary microvascular function will be evaluated by adenosine stress echocardiography. Coronary blood flow velocities will be measured at 1, 2, and 3 min after adenosine infusion.\n\nSex difference of coronary microvascular dysfunction evaluated by coronary flow reserve will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients who experienced chest pain but with no obstructed coronary arteries (\\<50% stenosis)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Typical/atypical chest pain or ischemic symptoms including dyspnea\n* No significant coronary artery stenosis (\\<50% stenosis) in coronary angiography or computed tomography\n\nExclusion Criteria:\n\n* ≥ Moderate valvular heart disease\n* Congenital heart disease\n* Chronic renal failure (estimated glomerular filtration rate \\<30 ml/min/1.73m2) or end-stage renal failure undergoing hemodialysis or peritoneal dialysis\n* Asthma, chronic obstructive pulmonary disease and primary pulmonary hypertension\n* Receiving anticancer drugs\n* Vasculitis associated with autoimmune diseases\n* Atrioventricular block with more than second degrees, symptomatic bradycardia, cryo-node failure syndrome, Wolff-Parkinson-White (WPW) patients'}, 'identificationModule': {'nctId': 'NCT06076551', 'briefTitle': 'Sex Difference of Coronary Microvascular Dysfunction in Patients With Non-obstructive Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'Korea University Anam Hospital'}, 'officialTitle': 'Sex Difference of Coronary Microvascular Dysfunction Evaluated by Coronary Flow Reserve in Patients With Non-obstructive Coronary Artery Disease', 'orgStudyIdInfo': {'id': '2017AN0358'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Adenosine stress echocardiography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Transthoracic echocardiographic assessments will be performed using an ultrasound device (Vivid E95, General Electric Healthcare, Liestal, Switzerland). Color Doppler flow of the distal left anterior descending artery was examined from the modified apical four-chamber view of the anterior interventricular groove. Pulsed-wave Doppler registered blood flow velocity patterns using a sample volume (2-3.0 mm) placed on the color signal. The ultrasound beam was aligned parallel to the vessel flow. The velocity scale of color Doppler was set to 0.21 m/s. Coronary flow Doppler images were acquired at baseline and at 1, 2, and 3 min after adenosine infusion in the same part of the artery. Anti-anginal medications, including calcium channel blockers, were discontinued before the study.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02841', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'So Ree Kim, PhD', 'role': 'CONTACT', 'email': 'soree8826kim@gmail.com'}, {'name': 'Seong-Mi Park', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mi-Na Kim', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dong-Hyuk Cho', 'role': 'SUB_INVESTIGATOR'}, {'name': 'So Ree Kim', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'So Ree Kim, PhD', 'role': 'CONTACT', 'email': 'soree8826kim@gmail.com', 'phone': '82-10-9453-4810'}], 'overallOfficials': [{'name': 'Seong-Mi Park, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University Anam Hospital'}, {'name': 'Mi-Na Kim, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Korea University Anam Hospital'}, {'name': 'Dong-Hyuk Cho, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Korea University Anam Hospital'}, {'name': 'So Ree Kim, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Korea University Anam Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University Anam Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Seong-Mi Park, M.D. Ph.D.', 'investigatorAffiliation': 'Korea University Anam Hospital'}}}}