Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2026-01-08 @ 8:55 AM
Study NCT ID:
NCT00154466
Status:
COMPLETED
Last Update Posted:
2014-06-26
First Post:
2005-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study on the Efficacy and Mechanism of Cardiac Rehabilitation for Stem Cell Mobilization and Heart Failure Improvement
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072038', 'term': 'Cardiac Rehabilitation'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lebai@ntu.edu.tw', 'phone': '0223123456', 'title': 'Dr. Bai-Chin Lee', 'phoneExt': '63352', 'organization': 'National Taiwan University Hospital'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'First, our trial is small size. Second, these results are applicable only for male patients less than 65 years old with ST-segment elevation MI after successful PCI. Third, the source of angiogenic cytokines cannot be elucidated.'}}, 'adverseEventsModule': {'timeFrame': 'Mean time from the onset of MI to initial evaluation was 8.3 (3.4) months. The groups did not differ in medication taken.No patients died, were hospitalized for coronary intervention, or had worsening symptoms during the 3-month study period.', 'description': 'At baseline and the 3-month follow-up, all patients underwent a functional evaluation that included clinical evaluation, exercise testing, cardiac MRI and measurements of plasma angiogenic cytokines levels. Both groups were receiving stable and optimal pharmacological treatment supervised by their physicians.', 'eventGroups': [{'id': 'EG000', 'title': 'Postinfarction Training Patients', 'description': '39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Postinfarction Nontraining Patients', 'description': '39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.', 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Healthy Controls', 'description': '39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.', 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Myocardial Blood Flow at Baseline and 3-month Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-infarction Training', 'description': 'Eligible patients who provided written informed consent were randomly assigned to the training group, which underwent a 3-month cardiac rehabilitation program, or the nontraining group in which patients continued their usual lifestyle. At baseline and the 3-month follow-up, all patients underwent a functional evaluation that included clinical evaluation, exercise testing, cardiac magnetic resonance imaging (MRI), and measurements of plasma angiogenic cytokines levels. Both groups were receiving stable and optimal pharmacologic treatment supervised by their physicians.'}, {'id': 'OG001', 'title': 'Post-infarction Nontraining', 'description': 'Eligible patients who provided written informed consent were randomly assigned to the training group, which underwent a 3-month cardiac rehabilitation program, or the nontraining group in which patients continued their usual lifestyle. At baseline and the 3-month follow-up, all patients underwent a functional evaluation that included clinical evaluation, exercise testing, cardiac magnetic resonance imaging (MRI), and measurements of plasma angiogenic cytokines levels. Both groups were receiving stable and optimal pharmacologic treatment supervised by their physicians.'}], 'classes': [{'title': 'Change of stress MBF in the remote myocardium', 'categories': [{'measurements': [{'value': '0.62', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '0.56', 'groupId': 'OG001'}]}]}, {'title': 'Change of stress MBF in the infarcted myocardium', 'categories': [{'measurements': [{'value': '0.44', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '0', 'spread': '0.46', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'First-pass, contrast-enhanced myocardial perfusion images acquired for 80 heart beats in the left ventricle. Short-axis views were obtained after intravenous administration of gadodiamide. Perfusion studies were performed at rest and during the stress induced by a 4 min infusion of dipyridamole at a concentration of 0.14 mg/kg of body weight per minute.To determine absolute MBF values at rest and stress status, we adopted a model-independent deconvolution method proposed by Jerosch-Herold et al, a method that was previously validated in experimental animal studies by comparison with blood-flow measurements with radiolabelled microspheres.', 'unitOfMeasure': 'ml/min/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients were randomly assigned to the training group, which underwent a 3-month cardiac rehabilitation program, or the nontraining group in which patients continued their usual lifestyle. Healthy controls underwent the test of myocardial perfusion only at baseline. The analysis was intention-to-treat.'}, {'type': 'SECONDARY', 'title': 'Angiogenic Cytokines at Baseline and 3-month Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-infarction Training', 'description': '39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.'}, {'id': 'OG001', 'title': 'Post-infarction Nontraining', 'description': '39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.'}, {'id': 'OG002', 'title': 'Healthy Controls', 'description': '19 age- and sex-matched healthy volunteers'}], 'classes': [{'title': 'Change of stromal-derived factor-1', 'categories': [{'measurements': [{'value': '-196', 'spread': '209', 'groupId': 'OG000'}, {'value': '-68', 'spread': '175', 'groupId': 'OG001'}, {'value': '-57', 'spread': '200', 'groupId': 'OG002'}]}]}, {'title': 'Change of vascular endothelial growth factor', 'categories': [{'measurements': [{'value': '0.70', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '0.95', 'spread': '1.46', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '2.92', 'groupId': 'OG002'}]}]}, {'title': 'Change of stem cell factor', 'categories': [{'measurements': [{'value': '20', 'spread': '120', 'groupId': 'OG000'}, {'value': '17', 'spread': '47', 'groupId': 'OG001'}, {'value': '-18', 'spread': '60', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': "Angiogenic cytokines such as vascular endothelial growth factor (VEGF), stromal-derived factor-1 (SDF-1) and stem cell factor (SCF) are known to increase the formation of new vessels at ischaemic sites and thus enhance myocardial perfusion. To rule out any effect of short-term exercise on cytokines levels, blood samples were always taken after at least 72 h of physical inactivity and overnight fasting when the subject had rested in the sitting position for at least 10 min. The plasma samples were immediately frozen and stored at -70°C. High-sensitivity ELISA (Bender MedSystems, R\\&D) were used to measure plasma levels of SCF, SDF-1 and VEGF according to the manufacturer's protocols.", 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "We calculated that we would need 18 patients in each group to achieve a power of at least 80% to detect a 20% difference in MBF change between study groups, with a two-sided significance level of p\\<0.05, and a 20% increase for the stress MBF change from baseline to 3 months' follow-up. The analysis was intention-to-treat."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Post-infarction Training', 'description': 'which underwent a 3-month cardiac rehabilitation program'}, {'id': 'FG001', 'title': 'Post-infarction Nontraining', 'description': 'in which patients continued their usual lifestyle.'}, {'id': 'FG002', 'title': 'Healthy Controls', 'description': 'For comparison of myocardial perfusion and angiogenic cytokines, 19 age-, weight-, and height-matched subjects without cardiovascular risk factors were selected as healthy controls.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'comment': 'Healthy controls underwent the test of myocardial perfusion only at baseline.', 'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This prospective randomised controlled study was approved by the ethics committee of the National Taiwan University Hospital. Between August 2004 and December 2005, 91 postinfarction patients were informed about the trial. Thirty-seven refused to participate and 15 did not meet the inclusion criteria.', 'preAssignmentDetails': 'Inclusion criteria:a successful primary stenting, a clinically stable course after MI, and no ischemia on exercise testing. Exclusion criteria: effort angina, Af, sustained ventricular arrhythmia, NYHA functional class IV, exercise-limiting diseases, severe pulmonary or renal disease, an implanted pacemaker, or claustrophobia.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Postinfarction Training Patients', 'description': '39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.'}, {'id': 'BG001', 'title': 'Postinfarction Nontraining Patients', 'description': '39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.'}, {'id': 'BG002', 'title': 'Healthy Controls', 'description': '39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52', 'spread': '8', 'groupId': 'BG000'}, {'value': '52', 'spread': '9', 'groupId': 'BG001'}, {'value': '50', 'spread': '9', 'groupId': 'BG002'}, {'value': '52', 'spread': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Taiwan', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-25', 'studyFirstSubmitDate': '2005-09-09', 'resultsFirstSubmitDate': '2012-12-06', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-25', 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Myocardial Blood Flow at Baseline and 3-month Follow-up', 'timeFrame': '3 months', 'description': 'First-pass, contrast-enhanced myocardial perfusion images acquired for 80 heart beats in the left ventricle. Short-axis views were obtained after intravenous administration of gadodiamide. Perfusion studies were performed at rest and during the stress induced by a 4 min infusion of dipyridamole at a concentration of 0.14 mg/kg of body weight per minute.To determine absolute MBF values at rest and stress status, we adopted a model-independent deconvolution method proposed by Jerosch-Herold et al, a method that was previously validated in experimental animal studies by comparison with blood-flow measurements with radiolabelled microspheres.'}], 'secondaryOutcomes': [{'measure': 'Angiogenic Cytokines at Baseline and 3-month Follow-up', 'timeFrame': '3 months', 'description': "Angiogenic cytokines such as vascular endothelial growth factor (VEGF), stromal-derived factor-1 (SDF-1) and stem cell factor (SCF) are known to increase the formation of new vessels at ischaemic sites and thus enhance myocardial perfusion. To rule out any effect of short-term exercise on cytokines levels, blood samples were always taken after at least 72 h of physical inactivity and overnight fasting when the subject had rested in the sitting position for at least 10 min. The plasma samples were immediately frozen and stored at -70°C. High-sensitivity ELISA (Bender MedSystems, R\\&D) were used to measure plasma levels of SCF, SDF-1 and VEGF according to the manufacturer's protocols."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Myocardial infarction, stem cell, cardiac rehabilitation'], 'conditions': ['Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '19304668', 'type': 'RESULT', 'citation': 'Lee BC, Hsu HC, Tseng WY, Su MY, Chen SY, Wu YW, Chien KL, Chen MF. Effect of cardiac rehabilitation on angiogenic cytokines in postinfarction patients. Heart. 2009 Jun;95(12):1012-8. doi: 10.1136/hrt.2008.153510. Epub 2009 Mar 19.'}]}, 'descriptionModule': {'briefSummary': 'One emerging concept is that some form of injury or inflammation is a prerequisite for the success of circulating-cell participation in differentiated tissue structure and function. Once reperfusion is achieved in acute myocardial infarction, an intense inflammatory cascade is unleashed.\n\nThe architecture of the left ventricle rearranges, leading to ventricular remodeling. The "homing process"involves stem cell migration to the sites of injury or ischemia, which provides an environment that is favorable to growth and function. This microenvironment is a stimulus for homing and differentiation of stem cells of the appropriate lineage. It increases vascular permeability and expression of adhesion proteins like integrin, along with homing receptors that facilitate the attachment, which is mediated by cell-to-cell contact and chemoattractant release from local tissue injury.The migratory capacity of stem cells might be dependent on natural growth factors such as vascular endothelial growth factor (VEGF) , stromal cell-derived factor-1 (SDF-1)and stem cell factor (SCF).The expression of VEGF ,SDF-1 and SCF is highly up-regulated in hypoxic tissue, supporting the hypothesis that these factors may represent homing signals crucial to the recruitment of circulating progenitor cells to assist the endogenous repair mechanisms in the infarcted tissue. This study will examine whether cardiac rehabilitation increases the concentration of stem cell factors released into the bloodstream and if these factors are correlated with the improvement of heart function.', 'detailedDescription': 'Exercise training has beneficial hemodynamic effects in patients with congestive heart failure.A similar benefit may be seen after MI, with an improvement in functional capacity averaging 20 percent. More important, however, is the possible effect on survival. In a meta-analysis of 24 trials examining the effect of cardiac rehabilitation after MI, there was a significant reduction in mortality with rehabilitation (odds ratio 0.81).\n\nPrevious studies focused on the effect of rehabilitation comes from the improvement of oxygen utilization in skeletal muscle. The effects on cardiac morphology and perfusion status were rather little to be addressed.\n\nIn this study, we will collect the questionaires, blood sampling for assay of stem cell factors, maximal O2 consumption, and cardiac MRI before and after cardiac rehabilitation.SDF-1 (stromal cell derived factor-1), SCF(stem cell factor), and VEGF (vasculoendothelial growth factor) will be measured by ELISA. Cardiac MRI will provide the information about (1) LV function, (2) scar size, and (3) perfusion status (dipyridamole stress MRI).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: myocardial infarction with CK more than 3000, status post revascularization therapy, clinical stable with regular follow-up at OPD, NYHA II-III -\n\nExclusion Criteria:sustained ventricular arrhythmia, hypertrophy cardiomyopathy, intolerance to exercise program\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00154466', 'briefTitle': 'Study on the Efficacy and Mechanism of Cardiac Rehabilitation for Stem Cell Mobilization and Heart Failure Improvement', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'An Association Study Between Cardiac Rehabilitation and Stem Cell Mobilization in Patients With Myocardial Infarction', 'orgStudyIdInfo': {'id': '9261701248'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cardiac rehabilitation', 'description': 'Those in the training group participated in a 3-month rehabilitation training program at an exercise intensity of 55% to 70% of peak oxygen uptake (VO2.', 'interventionNames': ['Behavioral: cardiac rehabilitation']}, {'type': 'NO_INTERVENTION', 'label': 'postinfarction patients', 'description': 'those in the nontraining group continued their usual lifestyle'}, {'type': 'PLACEBO_COMPARATOR', 'label': 'healthy controls', 'description': 'Age-, weight-, and height-matched subjects without cardiovascular risk factors were selected as healthy controls.'}], 'interventions': [{'name': 'cardiac rehabilitation', 'type': 'BEHAVIORAL', 'otherNames': ['exercise training'], 'description': 'Those in the training group participated in a 3-month rehabilitation training program at an exercise intensity of 55% to 70% of peak oxygen uptake (VO2); those in the nontraining group continued their usual lifestyle.', 'armGroupLabels': ['cardiac rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Bai-Chin Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}, {'name': 'Ssu-Yuan Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}, {'name': 'Wen-Yih Tseng, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}, {'name': 'Ming-Fong Chen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}