Cardiac Magnetic Resonance Imaging for Detecting Endothelial Dysfunction

Diabetes Clinical Trial

Official title:

A Pilot Study of Cardiac Magnetic Resonance Imaging For Detection of Myocardial Perfusion Abnormalities in Endothelial Dysfunction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00808535
• Other study ID #: CMRI_Perfusion Study
• Status: Not yet recruiting
• Phase: N/A
• First received: December 15, 2008
• Last updated: February 6, 2009
• Start date: February 2009
• Est. completion date: March 2010

Study information

• Verified date: February 2009
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac MRI Perfusion With Vasomotor Stress
• Congenital Abnormalities
• Diabetes
• Endothelial Dysfunction
• Myocardial Perfusion Abnormalities

Intervention

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.

Locations

Country	Name	City	State
United States	UCLA Radiological Sciences	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Bracco Diagnostics, Inc

Country where clinical trial is conducted

United States,