Cardiac Magnetic Resonance Imaging for Detecting Endothelial Dysfunction
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of California, Los Angeles.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
University of California, Los Angeles
Collaborator:
Bracco Diagnostics, Inc
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00808535
First received: December 15, 2008
Last updated: February 6, 2009
Last verified: February 2009
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Purpose
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.
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.
| Condition | Intervention |
|---|---|
|
Endothelial Dysfunction Myocardial Perfusion Abnormalities Cardiac MRI Perfusion With Vasomotor Stress Diabetes |
Procedure: Cardiac Perfusion MRI w Vasomotor Stress |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | A Pilot Study of Cardiac Magnetic Resonance Imaging For Detection of Myocardial Perfusion Abnormalities in Endothelial Dysfunction |
Resource links provided by NLM:
Further study details as provided by University of California, Los Angeles:
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| diabetics |
Procedure: 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 |
Procedure: 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| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Population
Diagnosed diabetics (less than 5 years) without documented coronary artery disease recruited from UCLA Ambulatory clinics.
Healthy controls from general population.
Criteria
Inclusion Criteria:
- Age 18 to 50 years
- 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:
- Children under 18 years and adults above 50 years
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00808535
Locations
| United States, California | |
| UCLA Radiological Sciences | Not yet recruiting |
| Los Angeles, California, United States, 91324 | |
| Contact: Wanda C Marfori, MD 310-206-2531 wmarfori@mednet.ucla.edu | |
| Contact: Stefan Ruehm, MD 3108250958 sruehm@mednet.ucla.edu | |
| Principal Investigator: Stefan Ruehm, MD | |
| Sub-Investigator: Jonathan Goldin, MD, PhD | |
| Sub-Investigator: Mayil Krishnam, MD | |
| Sub-Investigator: Christine Darwin, MD | |
Sponsors and Collaborators
University of California, Los Angeles
Bracco Diagnostics, Inc
Investigators
| Principal Investigator: | Stefan Ruehm, MD | University of California, Los Angeles |
More Information
No publications provided
| Responsible Party: | Stefan Ruehm, MD, UCLA |
| ClinicalTrials.gov Identifier: | NCT00808535 History of Changes |
| Other Study ID Numbers: | CMRI_Perfusion Study |
| Study First Received: | December 15, 2008 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Los Angeles:
|
Endothelial dysfunction Cardiac Perfusion MRI Vasomotor Stress Cold Pressor Test Adenosine Stress |
Additional relevant MeSH terms:
|
Congenital Abnormalities |
ClinicalTrials.gov processed this record on June 18, 2013