Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2025-12-29 @ 5:43 PM
Study NCT ID:
NCT00271492
Status:
COMPLETED
Last Update Posted:
2010-04-30
First Post:
2005-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation of Endothelial Function and Early Coronary Artery Disease in Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077868', 'term': 'Atrasentan'}], 'ancestors': [{'id': 'D052117', 'term': 'Benzodioxoles'}, {'id': 'D004149', 'term': 'Dioxoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-04-28', 'studyFirstSubmitDate': '2005-12-29', 'studyFirstSubmitQcDate': '2005-12-29', 'lastUpdatePostDateStruct': {'date': '2010-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To find out what effects (good and bad) the medication Atrasentan has on the heart', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Endothelial Dysfunction']}, 'referencesModule': {'references': [{'pmid': '20733096', 'type': 'DERIVED', 'citation': 'Reriani M, Raichlin E, Prasad A, Mathew V, Pumper GM, Nelson RE, Lennon R, Rihal C, Lerman LO, Lerman A. Long-term administration of endothelin receptor antagonist improves coronary endothelial function in patients with early atherosclerosis. Circulation. 2010 Sep 7;122(10):958-66. doi: 10.1161/CIRCULATIONAHA.110.967406. Epub 2010 Aug 23.'}]}, 'descriptionModule': {'briefSummary': 'Qualifying patients who are scheduled for angiogram with endothelial function testing are approached to participate in this protocol (consent form reviewed with patient). Those who are willing to participate will have additional measurements taken during their angiogram as part of this protocol. Patients who are diagnosed with Endothelial Dysfunction as a result of a clinically indicated angiogram will be eligible to participate in a 6 month medication trial (Atrasentan vs. placebo - randomized, blinded trial). Patients are monitored closely during the 6 month trial via phone calls and blood testing for assessment. At the end of the 6 months they return to Mayo for a repeat angiogram to assess endothelial function for any changes or improvements.', 'detailedDescription': 'Aim I: To determine the activity of the endogenous endothelin system in the coronary circulation in humans with coronary endothelial dysfunction and atherosclerosis risk factors. Aim II: To assess the potential of chronic endothelin receptor antagonists to improve preexisting coronary endothelial dysfunction and myocardial perfusion in humans and Aim III: To assess the effect of chronic endothelin receptor antagonism on the endogenous nitric oxide system in association with oxidative stress in humans with early coronary disease risk factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years and \\< 85 years\n* Male or female\n\nExclusion criteria:\n\n* Left dominant circulation\n* Heart failure with EF \\<40%\n* Unstable angina\n* MI or angioplasty of the LAD or circumflex with 6 months prior to entry into the study\n* Use of radiographic contrast agent within 12 hours of entry into the study\n* Use of investigational agents within one month of entry into the study\n* Patients who require treatment with positive inotropic agents other than digoxin during the study\n* Patients with cerebrovascular accident within 6 months prior to entry into the study\n* Significant endocrine, hepatic, renal disorders; local or systemic infectious disease within 4 weeks prior to entry into study\n* Pregnancy or lactation\n* Mental instability\n* Federal Medical Center patients'}, 'identificationModule': {'nctId': 'NCT00271492', 'briefTitle': 'Correlation of Endothelial Function and Early Coronary Artery Disease in Humans', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Endothelin in the Coronary Circulation in Early Atherosclerosis in Humans', 'orgStudyIdInfo': {'id': '48-99'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'I', 'description': 'Qualifying patients took Atrasentan, 1 pill per day for 6 months, to determine if it had a favorable affect on patients who took it over those who were randomized to placebo.', 'interventionNames': ['Drug: Atrasentan']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'placebo group to be compared to the actual medication', 'interventionNames': ['Drug: atrasentan']}], 'interventions': [{'name': 'Atrasentan', 'type': 'DRUG', 'otherNames': ['Xinlay'], 'description': '1 10mg capsule to be taken daily for 6 month study period.', 'armGroupLabels': ['I']}, {'name': 'Atrasentan', 'type': 'DRUG', 'otherNames': ['Xinlay'], 'description': '1 10mg capsule per day for the 6 month study period.', 'armGroupLabels': ['I']}, {'name': 'atrasentan', 'type': 'DRUG', 'otherNames': ['Xinlay'], 'description': 'One 10 mg capsule per day for 6 month study period', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Amir Lerman, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Amir Lerman, M.D.', 'oldOrganization': 'Mayo Clinic'}}}}