Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2026-01-05 @ 5:47 PM
Study NCT ID:
NCT04959357
Status:
COMPLETED
Last Update Posted:
2021-07-13
First Post:
2021-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Evaluation of Left Ventricular Systolic Function in Different Types of Ischemic Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013180', 'term': 'Sprains and Strains'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 242}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-12', 'studyFirstSubmitDate': '2021-06-27', 'studyFirstSubmitQcDate': '2021-07-12', 'lastUpdatePostDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'global longitudinal strain', 'timeFrame': '15/3/2018-30/12/2018', 'description': 'global longitudinal strain of CMD group and obstructive CAD group'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False}, 'conditionsModule': {'keywords': ['two-dimensional speckle tracking imaging', 'strain', 'coronary microvascular dysfunction'], 'conditions': ['Coronary Microvascular Dysfunction', 'Obstructive Coronary Heart Disease']}, 'descriptionModule': {'briefSummary': 'The study was designed to evaluate the left ventricular longitudinal strain and strain rate assessed by 2D-STI in patients with coronary microvascular dysfunction (CMD) or obstructive coronary artery disease (CAD) , to investigate the effect of different types of ischemic heart disease on the LV systolic function, and to explore the value of LS on the diagnosis of coronary microvascular dysfunction.', 'detailedDescription': 'A total of 175 patients with chest pain, without wall motion abnormality and without significant coronary artery stenosis (\\<50%) assessed by coronary angiography or coronary computed tomography were enrolled from July 2011 to December 2017. Coronary flow reserve (CFR) of these patients were detected by transthoracic Doppler echocardiography. The patients were divided into coronary microvascular dysfunction group ( CFR≤2.5, n=67) and control group (CFR\\>2.5, n=108). At the same time, 67 age-matched patients with any major coronary arteries stenosis≥50% and without wall motion abnormality were involved into the obstructive coronary artery disease group. Parameters of global longitudinal strain (LS) and strain rate, subendocardial LS and subepicardial LS were quantified by 2D-STI, the differences of these parameters among three groups were analyzed，correlation analysis、univariate and multivariate analysis and receiver operating characteristic curve were used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 242 patients were enrolled, including 102 males (42.1%) and 140 females (57.9%). Their ages ranged from 44 to 81 years, with an average age of (62.6 + 8.3) years.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age from 18-85 years\n\nExclusion Criteria:\n\n* patients with history of myocardial infarction or abnormal wall motion suggested by conventional echocardiography\n* patients with acute heart failure, chronic heart failure or LVEF values less than 50%\n* patients with congenital heart disease, severe valvular disease, severe bradycardia, high atrioventricular block and atrial fibrillation\n* patients who did not store ultrasound images or whose ultrasound images were unclear\n* patients who had incomplete clinical data'}, 'identificationModule': {'nctId': 'NCT04959357', 'briefTitle': 'The Evaluation of Left Ventricular Systolic Function in Different Types of Ischemic Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'The Evaluation of Left Ventricular Systolic Function in Different Types of Ischemic Heart Disease by Two-dimensional Speckle-tracking Echocardiography', 'orgStudyIdInfo': {'id': '048-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'coronary microvascular dysfunction group', 'interventionNames': ['Diagnostic Test: Two dimensional speckle tracking imaging']}, {'label': 'obstructive coronary artery disease', 'interventionNames': ['Diagnostic Test: Two dimensional speckle tracking imaging']}, {'label': 'control group', 'interventionNames': ['Diagnostic Test: Two dimensional speckle tracking imaging']}], 'interventions': [{'name': 'Two dimensional speckle tracking imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'lobal longitudinal strain and strain rate, subendocardial LS and subepicardial LS were quantified by two dimensional speckle tracking imaging', 'armGroupLabels': ['control group', 'coronary microvascular dysfunction group', 'obstructive coronary artery disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Department of Cardiology, Peking University Third Hospital, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Li Zhaoping, professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Peking University Third Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}