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Cardiac Magnetic Resonance Imaging for Detecting Endothelial Dysfunction

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00808535
Enrollment
60
Registered
2008-12-16
Start date
2009-02-28
Completion date
2010-03-31
Last updated
2009-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac MRI Perfusion With Vasomotor Stress, Diabetes, Endothelial Dysfunction, Myocardial Perfusion Abnormalities

Keywords

Endothelial dysfunction, Cardiac Perfusion MRI, Vasomotor Stress, Cold Pressor Test, Adenosine Stress

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.

Interventions

PROCEDURECardiac 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.

Sponsors

Bracco Diagnostics, Inc
CollaboratorINDUSTRY
University of California, Los Angeles
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026