Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-29 @ 1:21 AM
Study NCT ID:
NCT00925834
Status:
COMPLETED
Last Update Posted:
2009-06-22
First Post:
2009-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Suggestive Effects on the Diameter of Coronary Arteries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-19', 'studyFirstSubmitDate': '2009-06-19', 'studyFirstSubmitQcDate': '2009-06-19', 'lastUpdatePostDateStruct': {'date': '2009-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stenosis Diameter (Quantitative Coronary Analysis)', 'timeFrame': '60 sec after intervention'}], 'secondaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': 'immediately before and after intervention'}, {'measure': 'Systolic blood pressure', 'timeFrame': 'immediately before and after intervention'}, {'measure': 'Diastolic blood pressure', 'timeFrame': 'immediately before and after intervention'}, {'measure': 'Chest Pain', 'timeFrame': 'immediately before and after intervention'}, {'measure': 'Subjective distress', 'timeFrame': 'immediately before and after intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Coronary angiography', 'Placebo effect', 'Suggestion'], 'conditions': ['Coronary Circulation']}, 'descriptionModule': {'briefSummary': 'The aim of this randomized controlled pilot study was to answer the following questions:\n\n1. Is it possible to affect the diameter of coronary arteries through a placebo injection, which is administered intracoronarily together with a standardized verbal suggestion of coronary vasodilation?\n2. Is it possible to affect the diameter of coronary arteries through a pharmacologically underdosed nitroglycerine injection, which is administered intracoronarily together with a standardized verbal suggestion of coronary vasodilation?', 'detailedDescription': "The present study is a randomized controlled double-blind single center study in order to investigate the effects of verbal suggestions ('vasodilatation') in combination with either a placebo-intervention (sodium chloride 0.9%) or an underdosed vasodilating medication (nitroglycerine) on the diameter of coronary arteries. 60 patients with a clinical indication to undergo a coronary angiogram were recruited in the German Heart Centre Munich. Patients with acute myocardial events and the necessity for coronary intervention were excluded from the study. Patients were randomized into one of four arms of the two experiments:\n\nExperiment A: Intracoronary (i.c.) placebo-infusion together with a standardized verbal suggestion of coronary vasodilation vs. i.c. placebo-infusion without verbal suggestion.\n\nExperiment B: i.c. infusion of a very low dosed nitroglycerin together with a standardized verbal suggestion of coronary vasodilation vs. i.c. nitroglycerine infusion without verbal suggestion.\n\nTo our best knowledge this study is the first to investigate the modulating effects of verbal suggestions going along with medical interventions on the diameter of coronary arteries during heart catheterization."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* medical indication for heart catheterization\n* written informed consent\n\nExclusion Criteria:\n\n* acute myocardial infarction\n* acute elevation of cardiac enzymes\n* regular intake of drugs containing nitroglycerin\n* intolerance of nitroglycerin\n* hypotension\n* renal insufficiency\n* diabetes mellitus\n* hyperthyroidism\n* pregnancy\n* acute psychiatric disease\n* cognitive impairment\n* prinzmetal's angina"}, 'identificationModule': {'nctId': 'NCT00925834', 'acronym': 'SUGO-KO', 'briefTitle': 'Suggestive Effects on the Diameter of Coronary Arteries', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Effects of Suggestive Components of Therapeutical Interventions on the Diameter of Coronary Arteries', 'orgStudyIdInfo': {'id': 'SUGOKO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Sodium chloride', 'description': 'Control arm "A": Hidden intracoronary infusion of 5ml sodium chloride', 'interventionNames': ['Behavioral: Verbal suggestions']}, {'type': 'EXPERIMENTAL', 'label': 'Sodium chloride and verbal suggestions', 'description': 'Experimental arm "A": Open intracoronary infusion of 5ml sodium chloride plus the suggestion of a vasodilatory effect on coronary vessels', 'interventionNames': ['Behavioral: Verbal suggestions']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nitroglycerin', 'description': 'Control arm "B": Hidden intracoronary infusion of 0.01mg nitroglycerin in 5 ml sodium chloride', 'interventionNames': ['Behavioral: Verbal suggestions']}, {'type': 'EXPERIMENTAL', 'label': 'Nitroglycerin and verbal suggestions', 'description': 'Control arm "B": Open intracoronary infusion of 0.01 mg nitroglycerin in 5 ml sodium chloride plus the suggestion of a vasodilatory effect on cardiac vessels', 'interventionNames': ['Behavioral: Verbal suggestions']}], 'interventions': [{'name': 'Verbal suggestions', 'type': 'BEHAVIORAL', 'description': 'Verbal suggestions of a vasodilatory effect on cardiac vessels', 'armGroupLabels': ['Nitroglycerin', 'Nitroglycerin and verbal suggestions', 'Sodium chloride', 'Sodium chloride and verbal suggestions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'Munich', 'country': 'Germany', 'facility': 'Department of Psychosomatic Medicine, Technische Universität München', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Joram Ronel, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Technical University of Munich'}, {'name': 'Karin Meißner, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ludwig-Maximilians-Universität München'}, {'name': 'Julinda Mehilli, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Deutsches Herzzentrum München'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, {'name': 'German Heart Center', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr. Joram Ronel, Dr. Karin Meissner', 'oldOrganization': 'Technische Universität München'}}}}