Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-01-03 @ 11:10 PM
Study NCT ID:
NCT02850432
Status:
UNKNOWN
Last Update Posted:
2017-04-07
First Post:
2016-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and MRI Cardiac Biomarkers on Peripheral Arterial Disease in Patients With Long Term DM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D000072700', 'term': 'Conservative Treatment'}, {'id': 'D012046', 'term': 'Rehabilitation'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2019-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-06', 'studyFirstSubmitDate': '2016-07-25', 'studyFirstSubmitQcDate': '2016-07-27', 'lastUpdatePostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-treatment improvement of peripheral artery disease', 'timeFrame': '2 years', 'description': 'To determine the combined benefit of clinical and MRI imaging parameters (cardiac and lower extremities) in treatment response monitoring and treatment outcome prediction.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Magnetic resonance imaging', 'Extracellular volume matrix fraction', 'Peripheral artery disease', 'Blood-oxygen level dependent', 'Cardiac function'], 'conditions': ['Peripheral Arterial Disease']}, 'referencesModule': {'references': [{'pmid': '36651955', 'type': 'DERIVED', 'citation': 'Lin YC, Fu TC, Lin G, Ng SH, Yeh CH, Ng SC, Chang TC, Juan YH. Using T1 mapping indices to evaluate muscle function and predict conservative treatment outcomes in diabetic patients with peripheral arterial disease. Eur Radiol. 2023 Jul;33(7):4927-4937. doi: 10.1007/s00330-023-09392-8. Epub 2023 Jan 18.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to establish a clinically feasible simultaneous evaluation of heart and lower limb using MRI and to assess the combined benefit of clinical and cardiac MRI imaging markers in the evaluation of PAD and prediction of treatment outcome.', 'detailedDescription': 'We expect to enroll about 60 long-term DM patients (\\>10 years) from main study. Patient will receive evaluation of the perfusion in the lower limb by using blood oxygenation-level dependent (BOLD) sequence with measurement of the extracellular volume fraction (ECV) as an indicator of fibrosis severity in calf muscles. All patients will receive cardiac MRI (cardiac function, ischemia and fibrosis) and MR angiography (severity of PAD). The baseline studies will be completed within 2 years and 3 additional follow-up studies will be performed by the end of 4th year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'The inclusion criteria include:\n\n1. Able to understand and provide signed informed consent\n2. DM history of 10 years and above\n3. Willing to receive 3 MRI follow-up and serum hematocrit examinations within 2 years, if applicable\n4. Willing to receive standard therapy such as surgery or medication\n5. Age between 18-80 years old\n\nThe exclusion criteria include:\n\n1. Pregnant or breast-feeding women\n2. Allergic MRI contrast medium\n3. Absolute contraindications to contrast MRI (e.g., metallic hazards, hemodynamic instability, pregnancy, known allergy to contrast medium).\n4. Contraindicated to MRI study: cardiac pacemaker, cochlear implantation, metallic object within eyeball\n5. Patients that refuse to, or has poor ability of understanding and comply study conditions, such as severe dementia or difficulty in mobility\n6. Patients having dialysis'}, 'identificationModule': {'nctId': 'NCT02850432', 'acronym': 'CMRPADDM', 'briefTitle': 'Clinical and MRI Cardiac Biomarkers on Peripheral Arterial Disease in Patients With Long Term DM', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'The Evolution and Impact of Clinical and MRI Cardiac Biomarkers on Peripheral Arterial Disease in Patients With Long Term DM', 'orgStudyIdInfo': {'id': 'CMRPG3F1311'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Invasive treatment', 'description': 'Endovascular therapy or surgery with medical therapy according to Trans-Atlantic Inter-Society Consensus II scoring system (TASC II)) as described in the main study protocol', 'interventionNames': ['Procedure: Invasive treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conservative treatment', 'description': 'rehabilitation with medical therapy', 'interventionNames': ['Other: Conservative treatment']}], 'interventions': [{'name': 'Invasive treatment', 'type': 'PROCEDURE', 'otherNames': ['Surgery or endovascular treatment'], 'description': 'Endovascular therapy or surgery with medical therapy according to Trans-Atlantic Inter-Society Consensus II scoring system (TASC II)) as described in the main study protocol', 'armGroupLabels': ['Invasive treatment']}, {'name': 'Conservative treatment', 'type': 'OTHER', 'otherNames': ['rehabilitation with medical therapy'], 'description': 'rehabilitation with medical therapy', 'armGroupLabels': ['Conservative treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Guishan', 'state': 'Taoyuan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yu-Hsiang Juan, MD', 'role': 'CONTACT', 'email': 'Jonat126@yahoo.com.tw', 'phone': '+886-9-75366388'}, {'name': 'Yu-Hsiang Juan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yu-Ching Lin, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chun-Chin Chang', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chen-Ming Sung', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jiun-jie Wang, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gigin Lin, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yun-Chung Cheung, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Shu-Hang Ng, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Koon-Kwan Ng, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jim Wu, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yu-Chun Lin', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Chang Gung Memorial Hospital', 'geoPoint': {'lat': 24.99436, 'lon': 121.33672}}], 'centralContacts': [{'name': 'Yu-Hsiang Juan, MD', 'role': 'CONTACT', 'email': 'Jonat126@yahoo.com.tw', 'phone': '+886-9-753-66388'}], 'overallOfficials': [{'name': 'Yu-Hsiang Juan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'We have to see if this corresponds to the IRB regulation.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary investigator', 'investigatorFullName': 'Yu-Hsiang Juan', 'investigatorAffiliation': 'Chang Gung Memorial Hospital'}}}}