Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-02-24 @ 3:37 PM
Study NCT ID:
NCT03803020
Status:
UNKNOWN
Last Update Posted:
2019-01-14
First Post:
2018-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Evaluation of Fractional Flow Reserve and D SPECT for the Intervention of Chronic Total Occlusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-10', 'studyFirstSubmitDate': '2018-12-28', 'studyFirstSubmitQcDate': '2019-01-10', 'lastUpdatePostDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'score of Seattle angina questionnaire', 'timeFrame': 'one year', 'description': 'the result of Seattle angina questionnaire'}, {'measure': 'socre of Self-Rating Anxiety Scale', 'timeFrame': 'one year', 'description': 'result of socre of Self-Rating Anxiety Scale'}, {'measure': 'socre of EuroQol five dimensions questionnaire', 'timeFrame': 'one year', 'description': 'result of EuroQol five dimensions questionnaire'}, {'measure': 'Composite of cardiac death, target vessel myocardial infarction and target lesion revascularization record in follow-up', 'timeFrame': 'one year', 'description': 'Composite of cardiac death, target vessel myocardial infarction and target lesion revascularization record in follow-up'}, {'measure': 'the success rate of Percutaneous Coronary Intervention', 'timeFrame': 'one year', 'description': 'the success rate of Percutaneous Coronary Intervention'}], 'secondaryOutcomes': [{'measure': 'rate of cardiac death rate', 'timeFrame': 'one year', 'description': 'rate of cardiac death rate in one year recorded in follow-up'}, {'measure': 'rate of target vessel revascularization rate', 'timeFrame': 'one year', 'description': 'rate of target vessel revascularization rate in one year recorded in follow-up'}, {'measure': 'rate of recurrent myocardial infarction rate', 'timeFrame': 'one year', 'description': 'rate of recurrent myocardial infarction rate in one year recorded in follow-up'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['coronary artery disease', 'chronic total occlusion', 'fractional flow reserve', 'single-photon emission computed tomography'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Coronary chronic total occlusions (CTOs) are defined as an occluded coronary vessel with TIMI defined as an occluded coronary vessel with TIMI (Thrombolysis in Myocardial Infarction) grade flow 0 and an estimated duration of at least 3 months. They are frequently encountered in patients undergoing coronary angiography. The application of contemporary techniques and the use of advanced dedicated equipment lead to high procedural success and low adverse events rates in experienced centers. Fractional flow reserve (FFR) is a validated tool to assess physiological severity of coronary artery disease and have a prognostic role after percutaneous coronary intervention (PCI). SPECT (Single-Photon Emission Computed Tomography) is the golden standard for detection of myocardial ischemia. Recanalization of a CTO leads to a number of anatomical and pathophysiological changes to the coronary circulation. These include anatomical and functional collateral vessels regression and significant lumen enlargement because of recovery of blood flow and restoration of vasomotor tone. The effect of PCI on CTO is unknown. The aim of this study was to assess the functional result of CTO PCI by measuring FFR and D SPECT before and immediately post-CTO PCI and at short-term follow-up.', 'detailedDescription': 'Coronary chronic total occlusions (CTOs) are defined as an occluded coronary vessel with TIMI defined as an occluded coronary vessel with TIMI (Thrombolysis in Myocardial Infarction) grade flow 0 and an estimated duration of at least 3 months. They are frequently encountered in patients undergoing coronary angiography. The application of contemporary techniques and the use of advanced dedicated equipment lead to high procedural success and low adverse events rates in experienced centers. Fractional flow reserve (FFR) is a validated tool to assess physiological severity of coronary artery disease and have a prognostic role after percutaneous coronary intervention (PCI). SPECT (Single-Photon Emission Computed Tomography) is the golden standard for detection of myocardial ischemia. Recanalization of a CTO leads to a number of anatomical and pathophysiological changes to the coronary circulation. These include anatomical and functional collateral vessels regression and significant lumen enlargement because of recovery of blood flow and restoration of vasomotor tone. The effect of PCI on CTO is unknown. The aim of this study was to assess the functional result of CTO PCI by measuring FFR and D SPECT before and immediately post-CTO PCI and at short-term follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients of single coronary chronic total occlusion', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>18 years old\n* single CTO lesions, or other stenosis have been PCI treated for more than one months\n* the diameter of target vessel ≥2.5mm\n* stable angina pectoris, or myocardial ischemia in the area of CTO lesions\n* the patients agree to this research plan and sign the consent form, and complete the follow-up\n\nExclusion Criteria:\n\n* Acute myocardial infarction in one month\n* In addition to the area of CTO lesions, there are serious untreated coronary lesions\n* bridge vascular CTO lesions\n* untreated coronary artery or cardiac surgery due to interventional complications, or intraoperative death\n* acute decompensated heart failure\n* allergies to contrast or radionuclide tracers\n* patients with planned pregnancies or lactation or 1 years after intervention\n* malignant neoplasms or life expectancy of less than 1 years\n* patients plan of surgery\n* patients cannot tolerate double antiplatelet therapy for at least 12 months\n* any condition that does not fit coronary intervention or is a drug-eluting stent'}, 'identificationModule': {'nctId': 'NCT03803020', 'briefTitle': 'The Evaluation of Fractional Flow Reserve and D SPECT for the Intervention of Chronic Total Occlusion', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'The Evaluation of Fractional Flow Reserve and D SPECT for the Intervention of Chronic Total Occlusion', 'orgStudyIdInfo': {'id': 'SHDC12018X05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'single coronary chronic total occlusion', 'description': 'symptomatic stable angina of single coronary chronic total occlusion without other coronary artery stenosis scheduled for elective PCI.\n\nfractional flow reserve and SPECT detection before and after intervention.', 'interventionNames': ['Other: fractional flow reserve and SPECT detection']}], 'interventions': [{'name': 'fractional flow reserve and SPECT detection', 'type': 'OTHER', 'description': 'fractional flow reserve and SPECT detection', 'armGroupLabels': ['single coronary chronic total occlusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'junbo Ge, Doctor', 'role': 'CONTACT', 'email': 'jbge@zs-hospital.sh.cn', 'phone': '+86-21-64041990'}, {'name': 'jianying Ma, Doctor', 'role': 'CONTACT', 'email': 'ma.jianying@zs-hospital.sh.cn', 'phone': '+8618616881653'}, {'name': 'Shufu Chang, doctor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rende Xu, doctor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Qing Qin, doctor', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Shufu chang, Doctor', 'role': 'CONTACT', 'email': 'chang.shufu@zs-hospital.sh.cn', 'phone': '+8618616881731'}, {'name': 'Shufu chang, Doctor', 'role': 'CONTACT', 'email': 'chang.shufu@zs-hospital.sh.cn', 'phone': '+18616881731'}], 'overallOfficials': [{'name': 'Jianying Ma, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Cardiology, Zhongshan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}