Ignite Creation Date:
2025-12-24 @ 4:17 PM
Ignite Modification Date:
2025-12-25 @ 2:14 PM
Study NCT ID:
NCT00166166
Status:
TERMINATED
Last Update Posted:
2018-08-15
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Endothelial Hyperpolarization in Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019789', 'term': 'Tetraethylammonium'}, {'id': 'D019323', 'term': 'omega-N-Methylarginine'}, {'id': 'D001920', 'term': 'Bradykinin'}, {'id': 'D009599', 'term': 'Nitroprusside'}, {'id': 'D000109', 'term': 'Acetylcholine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D015725', 'term': 'Fluconazole'}], 'ancestors': [{'id': 'D013757', 'term': 'Tetraethylammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009861', 'term': 'Onium Compounds'}, {'id': 'D001120', 'term': 'Arginine'}, {'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}, {'id': 'D007705', 'term': 'Kinins'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D005292', 'term': 'Ferricyanides'}, {'id': 'D003486', 'term': 'Cyanides'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005290', 'term': 'Ferric Compounds'}, {'id': 'D058085', 'term': 'Iron Compounds'}, {'id': 'D006856', 'term': 'Hydrogen Cyanide'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aquyyum@emory.edu', 'phone': '404-727-3655', 'title': 'Dr. Arshed Quyyumi', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Findings are limited to the forearm microcirculations, thus other vascular beds including conductance arteries warrant further investigation. Nevertheless, it is known that the contribution of EDHF is less in conductance vessels than in microvessels.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Healthy Controls', 'description': 'Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine', 'otherNumAtRisk': 103, 'otherNumAffected': 0, 'seriousNumAtRisk': 103, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Risk Factors', 'description': 'Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine', 'otherNumAtRisk': 71, 'otherNumAffected': 0, 'seriousNumAtRisk': 71, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change in Forearm Blood Flow (FBF) After Tetraethylammonium (TEA) Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls', 'description': 'Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and Tetraethylammonium (TEA).'}, {'id': 'OG001', 'title': 'Risk Factors', 'description': 'Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and Tetraethylammonium (TEA)'}], 'classes': [{'categories': [{'measurements': [{'value': '-18', 'spread': '16', 'groupId': 'OG000'}, {'value': '-24', 'spread': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 5 minutes', 'description': 'Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph at rest and after administration of tetraethylammonium (TEA). Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference from baseline FBF and after TEA administration.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 62 of the original 174 subjects were treated for this portion of the study.'}, {'type': 'PRIMARY', 'title': 'Percent Change in Forearm Blood Flow (FBF) After Administration of L-NG-monomethyl Arginine (L-NMMA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls', 'description': 'Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and L-NG-monomethyl Arginine (L-NMMA)'}, {'id': 'OG001', 'title': 'Risk Factors', 'description': 'Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and L-NG-monomethyl Arginine (L-NMMA)'}], 'classes': [{'categories': [{'measurements': [{'value': '-29', 'spread': '17', 'groupId': 'OG000'}, {'value': '-23', 'spread': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 5 minutes', 'description': 'Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after administration of L-NG-monomethyl Arginine (L-NMMA). Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference in FBF from baseline and after L-NMMA administration.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 62 of the original 174 subjects were treated for this portion of the study.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Forearm Blood Flow (FBF) After Administration of L-NG-monomethyl Arginine (L-NMMA) and Tetraethylammonium (TEA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls', 'description': 'Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and L-NG-monomethyl Arginine (L-NMMA)'}, {'id': 'OG001', 'title': 'Risk Factors', 'description': 'Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and L-NG-monomethyl Arginine (L-NMMA)'}], 'classes': [{'categories': [{'measurements': [{'value': '-38', 'spread': '17', 'groupId': 'OG000'}, {'value': '-39', 'spread': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 minutes, 10 minutes', 'description': 'Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after administration of L-NG-monomethyl Arginine (L-NMMA) and Tetraethylammonium (TEA). Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference in FBF from after L-NMMA administration and after TEA administration.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 62 of the original 174 subjects were treated for this portion of the study.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Forearm Blood Flow (FBF) After Fluconazole Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls', 'description': 'Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and fluconazole.'}, {'id': 'OG001', 'title': 'Risk Factors', 'description': 'Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and fluconazole'}], 'classes': [{'categories': [{'measurements': [{'value': '-13', 'spread': '16', 'groupId': 'OG000'}, {'value': '-17', 'spread': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 5 minutes', 'description': 'Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph at rest and after administration of fluconazole. Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference from baseline FBF and after fluconazole administration.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 33 of the original 174 subjects were treated for this portion of the study.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Forearm Blood Flow (FBF) After L-NG-monomethyl Arginine (L-NMMA) and Fluconazole Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls', 'description': 'Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of L-NG-monomethyl Arginine (L-NMMA), and fluconazole'}, {'id': 'OG001', 'title': 'Risk Factors', 'description': 'Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of L-NG-monomethyl Arginine (L-NMMA) and fluconazole'}], 'classes': [{'categories': [{'measurements': [{'value': '-26', 'spread': '22', 'groupId': 'OG000'}, {'value': '-26', 'spread': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 minutes, 10 minutes', 'description': 'Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after L-NMMA administration and administration of fluconazole. Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference in FBF after L-NMMA administration and then fluconazole administration.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 15 of the original 174 subjects were treated for this portion of the study.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Forearm Blood Flow (FBF) After Fluconazole and Tetraethylammonium (TEA) Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls', 'description': 'Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of fluconazole and Tetraethylammonium (TEA)'}], 'classes': [{'categories': [{'measurements': [{'value': '-22', 'spread': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 minutes, 10 minutes', 'description': 'Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after administration of fluconazole and Tetraethylammonium (TEA) administration. Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference from FBF after fluconazole administration and after Tetraethylammonium (TEA) administration.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 19 of the original 174 subjects were treated for this portion of the study.'}, {'type': 'SECONDARY', 'title': 'Forearm Blood Flow (FBF) After Sodium Nitroprusside Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls', 'description': 'Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of sodium nitroprusside'}, {'id': 'OG001', 'title': 'Risk Factors', 'description': 'Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of sodium nitroprusside'}], 'classes': [{'categories': [{'measurements': [{'value': '10.4', 'spread': '4', 'groupId': 'OG000'}, {'value': '10.9', 'spread': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 minutes', 'description': 'Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after administration of sodium nitroprusside. Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed.', 'unitOfMeasure': 'mL min^-1 * 100 mL^-1', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 80 of the original 174 subjects were treated for this portion of the study.'}, {'type': 'SECONDARY', 'title': 'Change in Tissue Plasminogen Activator (t-PA) Release', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls', 'description': 'Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of bradykinin'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'spread': '0.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 30 minutes', 'description': 'Individual net t-PA release at each time point were calculated by the following formula: net release = (Cv-CA) x {FBF x \\[101-hematocrit/100\\]}, where Cv and CA represent the concentration of t-PA in the brachial vein and artery, respectively. Change is the difference of t-PA at baseline and t-PA after bradykinin 400 ng/min', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 33 of the original 174 subjects were treated for this portion of the study.'}, {'type': 'SECONDARY', 'title': 'Change in Tissue Plasminogen Activator (t-PA) Release After Tetraethylammonium (TEA) and Bradykinin Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls', 'description': 'Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of bradykinin and Tetraethylammonium (TEA)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes, 60 minutes', 'description': 'Individual net t-PA release at each time point were calculated by the following formula: net release = (Cv-CA) x {FBF x \\[101-hematocrit/100\\]}, where Cv and CA represent the concentration of t-PA in the brachial vein and artery, respectively. Change is the difference of t-PA after Tetraethylammonium (TEA) and t-PA after bradykinin 400 ng/min', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 18 of the original 174 subjects were treated for this portion of the study.'}, {'type': 'SECONDARY', 'title': 'Change in Tissue Plasminogen Activator (t-PA) Release After Fluconazole and Bradykinin Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls', 'description': 'Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of bradykinin and fluconazole'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'spread': '1.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes, 60 minutes', 'description': 'Individual net t-PA release at each time point were calculated by the following formula: net release = (Cv-CA) x {FBF x \\[101-hematocrit/100\\]}, where Cv and CA represent the concentration of t-PA in the brachial vein and artery, respectively. Change is the difference of t-PA after fluconazole and t-PA after bradykinin 400 ng/min', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 11 of the original 174 subjects were treated for this portion of the study.'}, {'type': 'SECONDARY', 'title': 'Change in Tissue Plasminogen Activator (t-PA) Release After Fluconazole, Tetraethylammonium (TEA), and Bradykinin Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls', 'description': 'Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of bradykinin, fluconazole and tetraethylammonium (TEA)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '0.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 minutes, 90 minutes', 'description': 'Individual net t-PA release at each time point were calculated by the following formula: net release = (Cv-CA) x {FBF x \\[101-hematocrit/100\\]}, where Cv and CA represent the concentration of t-PA in the brachial vein and artery, respectively. Change is the difference of t-PA after fluconazole and tetraethylammonium (TEA) and t-PA after bradykinin 400 ng/min', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 10 of the original 174 subjects were treated for this portion of the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Controls', 'description': 'Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine'}, {'id': 'FG001', 'title': 'Risk Factors', 'description': 'Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Controls', 'description': 'Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine'}, {'id': 'BG001', 'title': 'Risk Factors', 'description': 'Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34', 'spread': '11', 'groupId': 'BG000'}, {'value': '46', 'spread': '12', 'groupId': 'BG001'}, {'value': '40', 'spread': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline characteristics represent subjects that completed the study.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174}}, 'statusModule': {'whyStopped': 'Limited clinical staff', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-17', 'studyFirstSubmitDate': '2005-09-13', 'resultsFirstSubmitDate': '2015-05-08', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-05-12', 'studyFirstPostDateStruct': {'date': '2005-09-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in Forearm Blood Flow (FBF) After Tetraethylammonium (TEA) Administration', 'timeFrame': 'Baseline, 5 minutes', 'description': 'Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph at rest and after administration of tetraethylammonium (TEA). Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference from baseline FBF and after TEA administration.'}, {'measure': 'Percent Change in Forearm Blood Flow (FBF) After Administration of L-NG-monomethyl Arginine (L-NMMA)', 'timeFrame': 'Baseline, 5 minutes', 'description': 'Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after administration of L-NG-monomethyl Arginine (L-NMMA). Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference in FBF from baseline and after L-NMMA administration.'}], 'secondaryOutcomes': [{'measure': 'Percent Change in Forearm Blood Flow (FBF) After Administration of L-NG-monomethyl Arginine (L-NMMA) and Tetraethylammonium (TEA)', 'timeFrame': '5 minutes, 10 minutes', 'description': 'Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after administration of L-NG-monomethyl Arginine (L-NMMA) and Tetraethylammonium (TEA). Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference in FBF from after L-NMMA administration and after TEA administration.'}, {'measure': 'Percent Change in Forearm Blood Flow (FBF) After Fluconazole Administration', 'timeFrame': 'Baseline, 5 minutes', 'description': 'Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph at rest and after administration of fluconazole. Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference from baseline FBF and after fluconazole administration.'}, {'measure': 'Percent Change in Forearm Blood Flow (FBF) After L-NG-monomethyl Arginine (L-NMMA) and Fluconazole Administration', 'timeFrame': '5 minutes, 10 minutes', 'description': 'Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after L-NMMA administration and administration of fluconazole. Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference in FBF after L-NMMA administration and then fluconazole administration.'}, {'measure': 'Percent Change in Forearm Blood Flow (FBF) After Fluconazole and Tetraethylammonium (TEA) Administration', 'timeFrame': '5 minutes, 10 minutes', 'description': 'Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after administration of fluconazole and Tetraethylammonium (TEA) administration. Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference from FBF after fluconazole administration and after Tetraethylammonium (TEA) administration.'}, {'measure': 'Forearm Blood Flow (FBF) After Sodium Nitroprusside Administration', 'timeFrame': '5 minutes', 'description': 'Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after administration of sodium nitroprusside. Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed.'}, {'measure': 'Change in Tissue Plasminogen Activator (t-PA) Release', 'timeFrame': 'Baseline, 30 minutes', 'description': 'Individual net t-PA release at each time point were calculated by the following formula: net release = (Cv-CA) x {FBF x \\[101-hematocrit/100\\]}, where Cv and CA represent the concentration of t-PA in the brachial vein and artery, respectively. Change is the difference of t-PA at baseline and t-PA after bradykinin 400 ng/min'}, {'measure': 'Change in Tissue Plasminogen Activator (t-PA) Release After Tetraethylammonium (TEA) and Bradykinin Administration', 'timeFrame': '30 minutes, 60 minutes', 'description': 'Individual net t-PA release at each time point were calculated by the following formula: net release = (Cv-CA) x {FBF x \\[101-hematocrit/100\\]}, where Cv and CA represent the concentration of t-PA in the brachial vein and artery, respectively. Change is the difference of t-PA after Tetraethylammonium (TEA) and t-PA after bradykinin 400 ng/min'}, {'measure': 'Change in Tissue Plasminogen Activator (t-PA) Release After Fluconazole and Bradykinin Administration', 'timeFrame': '30 minutes, 60 minutes', 'description': 'Individual net t-PA release at each time point were calculated by the following formula: net release = (Cv-CA) x {FBF x \\[101-hematocrit/100\\]}, where Cv and CA represent the concentration of t-PA in the brachial vein and artery, respectively. Change is the difference of t-PA after fluconazole and t-PA after bradykinin 400 ng/min'}, {'measure': 'Change in Tissue Plasminogen Activator (t-PA) Release After Fluconazole, Tetraethylammonium (TEA), and Bradykinin Administration', 'timeFrame': '60 minutes, 90 minutes', 'description': 'Individual net t-PA release at each time point were calculated by the following formula: net release = (Cv-CA) x {FBF x \\[101-hematocrit/100\\]}, where Cv and CA represent the concentration of t-PA in the brachial vein and artery, respectively. Change is the difference of t-PA after fluconazole and tetraethylammonium (TEA) and t-PA after bradykinin 400 ng/min'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hyperlipidaemia', 'EDHF', 'FMD'], 'conditions': ['Hyperlipidemia']}, 'referencesModule': {'references': [{'pmid': '21555712', 'type': 'RESULT', 'citation': 'Ozkor MA, Murrow JR, Rahman AM, Kavtaradze N, Lin J, Manatunga A, Quyyumi AA. Endothelium-derived hyperpolarizing factor determines resting and stimulated forearm vasodilator tone in health and in disease. Circulation. 2011 May 24;123(20):2244-53. doi: 10.1161/CIRCULATIONAHA.110.990317. Epub 2011 May 9.'}, {'pmid': '25648989', 'type': 'DERIVED', 'citation': 'Ozkor MA, Hayek SS, Rahman AM, Murrow JR, Kavtaradze N, Lin J, Manatunga A, Quyyumi AA. Contribution of endothelium-derived hyperpolarizing factor to exercise-induced vasodilation in health and hypercholesterolemia. Vasc Med. 2015 Feb;20(1):14-22. doi: 10.1177/1358863X14565374. Epub 2015 Feb 3.'}, {'pmid': '24925526', 'type': 'DERIVED', 'citation': 'Rahman AM, Murrow JR, Ozkor MA, Kavtaradze N, Lin J, De Staercke C, Hooper WC, Manatunga A, Hayek S, Quyyumi AA. Endothelium-derived hyperpolarizing factor mediates bradykinin-stimulated tissue plasminogen activator release in humans. J Vasc Res. 2014;51(3):200-8. doi: 10.1159/000362666. Epub 2014 Jun 4.'}, {'pmid': '24675657', 'type': 'DERIVED', 'citation': 'Ozkor MA, Rahman AM, Murrow JR, Kavtaradze N, Lin J, Manatunga A, Hayek S, Quyyumi AA. Differences in vascular nitric oxide and endothelium-derived hyperpolarizing factor bioavailability in blacks and whites. Arterioscler Thromb Vasc Biol. 2014 Jun;34(6):1320-7. doi: 10.1161/ATVBAHA.113.303136. Epub 2014 Mar 27.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to elucidate the role Endothelium-Derived Hyperpolarizing Factor (EDHF) plays in dilating blood vessels and whether it differs between healthy people and those with high cholesterol. A second purpose of the study is to determine the identity of EDHF.', 'detailedDescription': "The vascular endothelium synthesizes at least four potent vasodilator substances: nitric oxide (NO), prostacyclin, carbon monoxide and endothelium-derived hyperpolarizing factor (EDHF) that contribute to vasodilator tone, and to inhibition of platelet activation and inflammation. EDHF release is stimulated by receptor-dependent agonists such as acetylcholine and bradykinin (BK), and leads to hyperpolarization of the underlying smooth muscle cells presumably by opening Ca2+-activated K+ channels. Indirect pharmacological evidence suggests that EDHF is a cytochrome P450-derived arachidonic acid metabolite, presumably an epoxide. Although the pivotal role of NO to conduit vessel dilation in response to acute increases in shear stress is well known, its' contribution to dilation with sustained increases in flow are minimal, and may be due to EDHF release."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hyperlipidemic (LDL \\> 140)\n* Healthy Volunteer\n\nExclusion Criteria:\n\n* Pregnancy\n* Diabetes mellitus\n* Cardiovascular Disease\n* Hypertension\n* Use of any regular medications\n* Renal insufficiency\n* Smoking (current or within the past 5 years)\n* Bleeding disorder'}, 'identificationModule': {'nctId': 'NCT00166166', 'briefTitle': 'Endothelial Hyperpolarization in Humans', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Physiology and Pathologic Role of Endothelium-Derived Hyperpolarizing Factor in Humans', 'orgStudyIdInfo': {'id': 'IRB00021886'}, 'secondaryIdInfos': [{'id': '1R01HL079115-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01HL079115-01', 'type': 'NIH'}, {'id': '0605-2002', 'type': 'OTHER', 'domain': 'Other'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Controls', 'description': 'Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine', 'interventionNames': ['Drug: Tetraethylammonium (TEA)', 'Drug: L-NG-monomethyl Arginine (L-NMMA)', 'Drug: Bradykinin', 'Drug: Sodium nitroprusside', 'Drug: Acetylcholine', 'Drug: Saline', 'Drug: Fluconazole']}, {'type': 'EXPERIMENTAL', 'label': 'Risk Factors', 'description': 'Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine', 'interventionNames': ['Drug: Tetraethylammonium (TEA)', 'Drug: L-NG-monomethyl Arginine (L-NMMA)', 'Drug: Bradykinin', 'Drug: Sodium nitroprusside', 'Drug: Acetylcholine', 'Drug: Saline', 'Drug: Fluconazole']}], 'interventions': [{'name': 'Tetraethylammonium (TEA)', 'type': 'DRUG', 'description': '5 minute intra-arterial infusion of Tetraethylammonium at 1 mg/min', 'armGroupLabels': ['Healthy Controls', 'Risk Factors']}, {'name': 'L-NG-monomethyl Arginine (L-NMMA)', 'type': 'DRUG', 'otherNames': ['Methylarginine'], 'description': '5 minute intra-arterial infusion of L-NMMA 8 μmol/min', 'armGroupLabels': ['Healthy Controls', 'Risk Factors']}, {'name': 'Bradykinin', 'type': 'DRUG', 'description': 'Intra-arterial infusion of bradykinin at 100, 200, and 400 ng/min. Each dose will be given for 5 minutes.', 'armGroupLabels': ['Healthy Controls', 'Risk Factors']}, {'name': 'Sodium nitroprusside', 'type': 'DRUG', 'otherNames': ['Nitropress'], 'description': 'Intra-arterial infusion of sodium nitroprusside at 1.6 and 3.2 mg/min. Each dose will be given for 5 minutes.', 'armGroupLabels': ['Healthy Controls', 'Risk Factors']}, {'name': 'Acetylcholine', 'type': 'DRUG', 'description': 'Intra-arterial infusion of acetylcholine at 7.5, 15 and 30 μg/min. Each dose will be given for 5 minutes.', 'armGroupLabels': ['Healthy Controls', 'Risk Factors']}, {'name': 'Saline', 'type': 'DRUG', 'description': '5 minute intra-arterial infusion of 0.9% saline at 2.5ml/min', 'armGroupLabels': ['Healthy Controls', 'Risk Factors']}, {'name': 'Fluconazole', 'type': 'DRUG', 'otherNames': ['Diflucan'], 'description': '5 minute intra-arterial infusion of fluconazole at 0.4 mg/L/min', 'armGroupLabels': ['Healthy Controls', 'Risk Factors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University School of Medicine', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Arshed A Quyyumi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University School of Medicine, Division of Cardiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Arshed A. Quyyumi', 'investigatorAffiliation': 'Emory University'}}}}