Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT01491256
Status:
UNKNOWN
Last Update Posted:
2011-12-13
First Post:
2011-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Index of Microcirculatory Resistance After Drug-Eluting Stent Implantation With High Dose Atorvastatin Loading
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-04-13', 'releaseDate': '2015-04-01'}, {'resetDate': '2018-02-23', 'releaseDate': '2017-08-19'}], 'estimatedResultsFirstSubmitDate': '2015-04-01'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2012-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-12-11', 'studyFirstSubmitDate': '2011-12-01', 'studyFirstSubmitQcDate': '2011-12-11', 'lastUpdatePostDateStruct': {'date': '2011-12-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Index of microcirculatory resistance (IMR)', 'timeFrame': 'Immediately after percutaneous coronary intervention', 'description': 'After stent implantation and adjunctive balloon dilatation, final angiogram will be taken. If the final angiogram shows successful results, IMR will be measured and the procedure will be finished.'}], 'secondaryOutcomes': [{'measure': 'Major Adverse Cardiovascular Events (death, myocardial infarction, target vessel failure', 'timeFrame': '1 year after index procedure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Index of microcirculatory resistance', 'atorvastatin', 'drug-eluting stent', 'acute coronary syndrome'], 'conditions': ['Acute Coronary Syndrome']}, 'descriptionModule': {'briefSummary': 'Pre-treatment with statins decreased the incidence of cardiac enzyme increase after percutaneous coronary intervention (PCI) and distal embolization suspected to cause post-PCI myocardial damage. This study evaluates the effect of high dose atorvastatin pre-treatment on post-procedural index of microcirculatory resistance (IMR) values that are introduced for assessing the status of the microcirculation.', 'detailedDescription': 'One hundred patients with non-ST elevation acute coronary syndrome will be randomly assigned to either high dose atorvastatin pre-treatment group(80 mg loading within 24 hours plus 40mg busting within 2 hours before PCI) or control group(atorvastatin 10mg administration within 24 hours before PCI). An intracoronary pressure/temperature sensor-tipped guidewire is used. Thermodilution curves are obtained during maximal hyperemia. The IMR was calculated from the ratio of the mean distal coronary pressure at maximal hyperemia to the inverse of mean hyperemic transit time. Creatine kinase-myocardial band(CK-MB) and CRP level will be measured at baseline and at 12\\~24 hours after PCI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of Non-ST elevation acute coronary syndrome planed to elective percutaneous coronary intervention\n\nExclusion Criteria:\n\n* ST elevation myocardial infarction\n* Cardiogenic shock\n* Congestive heart failure with pulmonary edema\n* Severe left ventricular dysfunction (LVEF \\< 30%)\n* History of previous coronary revascularization therapy\n* chronic total coronary occlusion\n* 3 vessel disease\n* Target lesion at distal segments or branches\n* Ostial lesion\n* Excessive coronary calcification or thrombi\n* Elevated transaminase\n* Renal dysfunction (serum creatinine \\> 2.0mg/dL\n* History of myopathy\n* Contra-indication to anti-platelet therapy\n* Not indicated for percutaneous coronary intervention\n* Other co-morbidity with life expectancy less than 1 year'}, 'identificationModule': {'nctId': 'NCT01491256', 'acronym': 'RESIST-ACS', 'briefTitle': 'Index of Microcirculatory Resistance After Drug-Eluting Stent Implantation With High Dose Atorvastatin Loading', 'organization': {'class': 'OTHER', 'fullName': 'The Korean Society of Circulation'}, 'officialTitle': 'Randomized Comparison Multicenter Trial of High Dose Atorvastatin Pre-treatment on Microcirculatory Dysfunction After Drug-ElutIng Stent Implantation in Patients With Acute Coronary Syndrome', 'orgStudyIdInfo': {'id': 'RESIST-ACS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High dose Atorvastatin', 'description': 'Arm of pre-procedural high dose atorvastatin loading', 'interventionNames': ['Drug: Pre-procedural High dose atorvastatin loading']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'No pre-procedural high dose atorvastatin loading', 'interventionNames': ['Drug: No pre-procedural high-dose atorvastatin loading']}], 'interventions': [{'name': 'Pre-procedural High dose atorvastatin loading', 'type': 'DRUG', 'otherNames': ['Lipitor (Pfizer)'], 'description': 'Atorvastatin 80 mg loading within 24 hours plus 40mg busting within 2 hours before percutaneous coronary intervention', 'armGroupLabels': ['High dose Atorvastatin']}, {'name': 'No pre-procedural high-dose atorvastatin loading', 'type': 'DRUG', 'otherNames': ['Lipitor (Pfizer)'], 'description': 'atorvastatin 10mg administration within 24 hours before percutaneous coronary intervention', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200-722', 'city': 'Chuncheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Bong-Ki Lee, MD, PhD', 'role': 'CONTACT', 'email': 'nicedr@nate.com', 'phone': '+82-10-6373-9290'}, {'name': 'Bon-Kwon Koo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Chang-WooK Nam, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Seung-Woon Rha, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Joon-Hyung Doh, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Woo-Young Chung, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Seung-Jae Tahk, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jin-Bae Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ki-Dong Yoo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kangwon National University Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}], 'centralContacts': [{'name': 'Bong-Ki Lee, MD, PhD', 'role': 'CONTACT', 'email': 'nicedr@nate.com', 'phone': '+82-10-6373-9290'}], 'overallOfficials': [{'name': 'Bong-Ki Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KangWon National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Korean Society of Circulation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistance Professor of Medicine, Kangwon National University School of Medicine', 'investigatorFullName': 'Bong-Ki Lee', 'investigatorAffiliation': 'The Korean Society of Circulation'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-04-01', 'type': 'RELEASE'}, {'date': '2015-04-13', 'type': 'RESET'}, {'date': '2017-08-19', 'type': 'RELEASE'}, {'date': '2018-02-23', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Bong-Ki Lee, Assistance Professor of Medicine, Kangwon National University School of Medicine, The Korean Society of Circulation'}}}}