Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-30 @ 5:04 PM
Study NCT ID:
NCT00808535
Status:
UNKNOWN
Last Update Posted:
2009-02-09
First Post:
2008-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Magnetic Resonance Imaging for Detecting Endothelial Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2010-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-02-06', 'studyFirstSubmitDate': '2008-12-15', 'studyFirstSubmitQcDate': '2008-12-15', 'lastUpdatePostDateStruct': {'date': '2009-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Endothelial dysfunction', 'Cardiac Perfusion MRI', 'Vasomotor Stress', 'Cold Pressor Test', 'Adenosine Stress'], 'conditions': ['Endothelial Dysfunction', 'Myocardial Perfusion Abnormalities', 'Cardiac MRI Perfusion With Vasomotor Stress', 'Diabetes']}, 'descriptionModule': {'briefSummary': 'The goal of this research study is to demonstrate that Cardiac Perfusion MRI with Vasomotor Stress may serve as a non-invasive and less risky imaging technique for detecting non-obstructive perfusion deficits and/or abnormalities in myocardial blood flow (MBF) in patients with endothelial dysfunction.\n\nThis is a controlled study, which will enroll approximately 60 subjects (30 diabetics and 30 non-diabetics to serve as healthy controls), and will include male and non-pregnant females, between the ages 18-50 years.\n\nAll eligible participants will sign an informed consent and will complete a Lifestyle Questionnaire. They will undergo blood work which includes:\n\n* 2-hour Oral Glucose Tolerance Test and Fasting Labs for Glucose, Insulin, C-Peptide, HbA1c, Creatinine, and Lipid Panel.\n* Urine Albumin to Creatinine ratio for microalbuminuria.\n* Serum inflammatory markers: E-selectin, homocysteine, ADMA, VCAM, IL-6, TNFalpha, hs-CRP and PAI-1.\n\nAfter blood work, all participants will undergo cardiac MR perfusion imaging procedure with Cold Pressor Test and Adenosine Stress Test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Diagnosed diabetics (less than 5 years) without documented coronary artery disease recruited from UCLA Ambulatory clinics.\n\nHealthy controls from general population.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 to 50 years\n* Should be able to sign an informed consent and HIPAA Agreement\n* 30 healthy, non-diabetic individuals\n* 30 diabetic individuals without documented coronary artery disease\n* Diagnosed diabetics less than 5 years\n* HbA1c less than 8.0\n\nExclusion Criteria:\n\n* Children under 18 years and adults above 50 years\n* Type 1 DM\n* Lactating and Pregnant females\n* BMI less than 35\n* Contraindication to MRI such as pacemaker, defibrillator implants, etc.\n* Allergy to MR (paramagnetic) contrast\n* History of Angina, MI, or documented Coronary Artery Disease\n* Previous history of CHF, CABG, Angioplasty and Stenting\n* History of Valvular Heart Disease and Congenital Heart Disease\n* History of Peripheral Vascular Disease\n* History of Cardiac Arrythmias and anti-coagulation therapy\n* History of Cerebro-vascular accidents or TIA\n* History of active diabetic retinopathy and nephropathy\n* Uncontrolled hypertension (systolic \\> 170 and diastolic \\>100 mm Hg\n* End Stage Renal Disease and patients on dialysis\n* HbA1c of 8.0\n* Creatinine greater than 1.7 mg/dl\n* History of active gastrointestinal bleeding\n* History of IV drug use\n* Chronic or current steroid treatment\n* Growth hormone treatment'}, 'identificationModule': {'nctId': 'NCT00808535', 'briefTitle': 'Cardiac Magnetic Resonance Imaging for Detecting Endothelial Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'A Pilot Study of Cardiac Magnetic Resonance Imaging For Detection of Myocardial Perfusion Abnormalities in Endothelial Dysfunction', 'orgStudyIdInfo': {'id': 'CMRI_Perfusion Study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'diabetics', 'interventionNames': ['Procedure: Cardiac Perfusion MRI w Vasomotor Stress']}, {'label': 'healthy controls', 'interventionNames': ['Procedure: Cardiac Perfusion MRI w Vasomotor Stress']}], 'interventions': [{'name': 'Cardiac Perfusion MRI w Vasomotor Stress', 'type': 'PROCEDURE', 'description': 'All participants will undergo Cardiac Perfusion MRI with Vasomotor Stress. Vasomotor Stress will include both Cold Pressor Test and Adenosine Stress Test.', 'armGroupLabels': ['diabetics', 'healthy controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91324', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Wanda C Marfori, MD', 'role': 'CONTACT', 'email': 'wmarfori@mednet.ucla.edu', 'phone': '310-206-2531'}, {'name': 'Stefan Ruehm, MD', 'role': 'CONTACT', 'email': 'sruehm@mednet.ucla.edu', 'phone': '3108250958'}, {'name': 'Stefan Ruehm, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jonathan Goldin, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mayil Krishnam, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christine Darwin, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'UCLA Radiological Sciences', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Stefan Ruehm, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bracco Diagnostics, Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Stefan Ruehm, MD', 'oldOrganization': 'UCLA'}}}}