Cardiac Magnetic Resonance Imaging for Detecting Endothelial Dysfunction
NCT ID: NCT00808535
Last Updated: 2009-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2009-02-28
2010-03-31
Brief Summary
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This 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.
All eligible participants will sign an informed consent and will complete a Lifestyle Questionnaire. They will undergo blood work which includes:
* 2-hour Oral Glucose Tolerance Test and Fasting Labs for Glucose, Insulin, C-Peptide, HbA1c, Creatinine, and Lipid Panel.
* Urine Albumin to Creatinine ratio for microalbuminuria.
* Serum inflammatory markers: E-selectin, homocysteine, ADMA, VCAM, IL-6, TNFalpha, hs-CRP and PAI-1.
After blood work, all participants will undergo cardiac MR perfusion imaging procedure with Cold Pressor Test and Adenosine Stress Test.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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diabetics
Cardiac Perfusion MRI w Vasomotor Stress
All participants will undergo Cardiac Perfusion MRI with Vasomotor Stress. Vasomotor Stress will include both Cold Pressor Test and Adenosine Stress Test.
healthy controls
Cardiac Perfusion MRI w Vasomotor Stress
All participants will undergo Cardiac Perfusion MRI with Vasomotor Stress. Vasomotor Stress will include both Cold Pressor Test and Adenosine Stress Test.
Interventions
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Cardiac Perfusion MRI w Vasomotor Stress
All participants will undergo Cardiac Perfusion MRI with Vasomotor Stress. Vasomotor Stress will include both Cold Pressor Test and Adenosine Stress Test.
Eligibility Criteria
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Inclusion Criteria
* Should be able to sign an informed consent and HIPAA Agreement
* 30 healthy, non-diabetic individuals
* 30 diabetic individuals without documented coronary artery disease
* Diagnosed diabetics less than 5 years
* HbA1c less than 8.0
Exclusion Criteria
* Type 1 DM
* Lactating and Pregnant females
* BMI less than 35
* Contraindication to MRI such as pacemaker, defibrillator implants, etc.
* Allergy to MR (paramagnetic) contrast
* History of Angina, MI, or documented Coronary Artery Disease
* Previous history of CHF, CABG, Angioplasty and Stenting
* History of Valvular Heart Disease and Congenital Heart Disease
* History of Peripheral Vascular Disease
* History of Cardiac Arrythmias and anti-coagulation therapy
* History of Cerebro-vascular accidents or TIA
* History of active diabetic retinopathy and nephropathy
* Uncontrolled hypertension (systolic \> 170 and diastolic \>100 mm Hg
* End Stage Renal Disease and patients on dialysis
* HbA1c of 8.0
* Creatinine greater than 1.7 mg/dl
* History of active gastrointestinal bleeding
* History of IV drug use
* Chronic or current steroid treatment
* Growth hormone treatment
18 Years
50 Years
ALL
Yes
Sponsors
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Bracco Diagnostics, Inc
INDUSTRY
University of California, Los Angeles
OTHER
Responsible Party
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UCLA
Principal Investigators
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Stefan Ruehm, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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UCLA Radiological Sciences
Los Angeles, California, United States
Countries
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Facility Contacts
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Other Identifiers
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CMRI_Perfusion Study
Identifier Type: -
Identifier Source: org_study_id
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