Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-01-29 @ 9:46 AM
Study NCT ID:
NCT00205166
Status:
COMPLETED
Last Update Posted:
2012-10-29
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Caffeine Affect the Sensitivity of Adenosine Perfusion Scans?
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': 'D002110', 'term': 'Caffeine'}], 'ancestors': [{'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-25', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2012-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'This protocol has a specific aim of determining whether prior caffeine administration affects the sensitivity and specificity of adenosine perfusion scintigraphy for detection of impaired coronary vascular reserve.', 'timeFrame': 'Assessment is made at the time of research adenosine perfusion scintigraphy'}], 'secondaryOutcomes': [{'measure': 'determination of caffeine levels in patients instructed to hold caffeine prior to adenosine imaging', 'timeFrame': 'Assess at time of lab sample results obtained'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['adenosine tracer scans', 'coronary artery disease', 'caffeine'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'We are studying the affect of caffeine on the sensitivity of detecting coronary artery disease (blockages in the blood flow to the heart) with adenosine tracer scans. Adenosine is a drug used routinely in patients to relax heart blood vessels in order to assess for the presence of coronary artery disease. Often, if patients have had caffeine, the adenosine scan is not used because of the belief that caffeine may reduce the ability to detect coronary artery disease. We would like to test whether caffeine affects our ability to detect coronary artery disease with adenosine tracer scanning. We will perform an imaging study of the heart with adenosine after you have received caffeine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have already completed rest/stress 99mTc sestamibi or 99mTc tetrofosmin imaging will be given a form describing this protocol and asked to volunteer for the additional scan\n\nExclusion Criteria:\n\n* history of asthma, bronchospastic COPD, or renal failure'}, 'identificationModule': {'nctId': 'NCT00205166', 'briefTitle': 'Does Caffeine Affect the Sensitivity of Adenosine Perfusion Scans?', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Does Caffeine Affect the Sensitivity of Adenosine Perfusion Scans?', 'orgStudyIdInfo': {'id': '1999-109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Caffeine 400 mg PO 1 hour before adenosine infusion', 'interventionNames': ['Procedure: Cardiac SPECT imaging Rest and Stress', 'Drug: Caffeine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Caffeine 200 mg po one hour before adenosine infusion', 'interventionNames': ['Procedure: Cardiac SPECT imaging Rest and Stress', 'Drug: Caffeine']}], 'interventions': [{'name': 'Cardiac SPECT imaging Rest and Stress', 'type': 'PROCEDURE', 'description': 'adenosine perfusion scintigraphy', 'armGroupLabels': ['1', '2']}, {'name': 'Caffeine', 'type': 'DRUG', 'description': 'Caffeine 400 mg po', 'armGroupLabels': ['1']}, {'name': 'Caffeine', 'type': 'DRUG', 'description': 'Caffeine 200 mg po', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Charles K Stone, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univeristy of Wisconsin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'Astellas Pharma US, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}