Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2026-02-22 @ 1:14 AM
Study NCT ID:
NCT01751295
Status:
UNKNOWN
Last Update Posted:
2012-12-17
First Post:
2012-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Statin and Post-interventional Coronary Microcirculation Dysfunction
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'}]}, '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': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-12-13', 'studyFirstSubmitDate': '2012-12-13', 'studyFirstSubmitQcDate': '2012-12-13', 'lastUpdatePostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-procedural IMR of PCI target vessel Post-procedural IMR of PCI target vessel', 'timeFrame': 'within 1 year after PCI'}], 'secondaryOutcomes': [{'measure': 'Post-procedural troponin I', 'timeFrame': 'within 1 year after PCI'}, {'measure': 'Post-procedural FFR', 'timeFrame': 'within 1 year after PCI'}, {'measure': 'Post-procedural IMR comparison of target vessel with non-target vessel', 'timeFrame': 'within 1 year after PCI'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of statin on the coronary microcirculation dysfunction measured after percutaneous coronary intervention.', 'detailedDescription': 'Development of peri-procedural myocardial infarction following percutaneous coronary intervention (PCI) is not uncommon and affects long-term prognosis. Clinical studies have shown that pre-treatment with atorvastatin reduced peri-procedural myocardial infarction in patients with stable angina. The mechanism of peri-procedural myocardial infarction is presumed to be microvascular embolization. However the direct causal relationship between statin pretreatment and prevention of microvascular dysfunction has not been investigated yet.\n\nIn this study, we will recruit symptomatic angina patients who have clinical indication of coronary angiography. At the time of enrollment, patients will be randomly assigned to pre-treatment group (atorvastatin 80 mg/d for 4 days) or control group. Percutaneous coronary intervention (PCI) will be perfomed based on the result of diagnostic coronary angiography by decision of attending physician. When PCI is performed, fractional flow reserve (FFR) and index of microvascular resistance (IMR) will be measured before and after the procedure. Periprocedural myocardial infarction will be defined by post-PCI cardiac biomarker. All patients will be followed for adverse cardiac events for 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A. Finished informed consent\n* B. Stable angina with clinical indication of coronary angiography\n* C. Age ≥ 21 year and ≤ 80 year\n\nExclusion Criteria:\n\n* A.Without informed consent\n* B.PCI target lesion is not adequate or not indicated for FFR/IMR study\n* C.Prior myocardial infarction or interventional procedure for PCI target vessel\n* D.Myocardial infarction within 30 days\n* E.Usage of statin, current or within 1 month\n* F.Prior bypass surgery\n* G.Impaired renal function (Creatinine \\> 2.0 mg/dL)\n* H.Impaired left ventricular function (ejection fraction \\< 40%)\n* I.Active hepatitis or abnormal hepatic transaminase level (\\> 3 ULN)\n* J.Contraindication for long-term antiplatelet agent or statin\n* K.Planning or potential of pregnancy\n* L.Neoplastic disease without evidence of treatment completion\n* M.Impaired general condition'}, 'identificationModule': {'nctId': 'NCT01751295', 'briefTitle': 'Statin and Post-interventional Coronary Microcirculation Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Effect of Statin on the Post-interventional Coronary Microcirculation Dysfunction', 'orgStudyIdInfo': {'id': '2012-08-052'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'atorvastatin', 'description': 'PCI with atorvastatin pre-treatment group', 'interventionNames': ['Drug: Atorvastatin, pre-treatment 80 mg/day for 4 days before PCI']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'PCI without atorvastatin pre-treatment group'}], 'interventions': [{'name': 'Atorvastatin, pre-treatment 80 mg/day for 4 days before PCI', 'type': 'DRUG', 'otherNames': ['lipinon'], 'armGroupLabels': ['atorvastatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'state': 'Gang nam-Gu, Ilwon-Dong', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Jin-Ho Choi', 'investigatorAffiliation': 'Samsung Medical Center'}}}}