Clinical trial NCT00808535: Cardiac Magnetic Resonance Imaging for Detecting Endothelial Dysfunction
Official title: A Pilot Study of Cardiac Magnetic Resonance Imaging For Detection of Myocardial Perfusion Abnormalities in Endothelial Dysfunction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endothelial Dysfunction
Myocardial Perfusion Abnormalities
Cardiac MRI Perfusion With Vasomotor Stress
Diabetes
Keywords: Endothelial dysfunction
Cardiac Perfusion MRI
Vasomotor Stress
Cold Pressor Test
Adenosine Stress
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Bracco Diagnostics, Inc
First posted: 2008-12-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Radiological Sciences
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Stefan Ruehm, MD
role: PRINCIPAL_INVESTIGATOR
References: