Cardiac Magnetic Resonance Imaging for Detecting Endothel... | NCT00808535

Studies
Cardiac Magnetic Resonance Imaging for Detecting Endothelial Dysfunction

NCT00808535

Sponsor

University of California, Los Angeles

Status

Unknown status

Last Update Posted

Feb 9, 2009Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

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

Interventions

Cardiac Perfusion MRI w Vasomotor Stress

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Feb 2010Estimated

Completion Date

Mar 2010Estimated

First Submitted Date

Dec 15, 2008

First Submission Date that Met QC Criteria

Dec 15, 2008

First Posted Date

Dec 16, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2009

Last Update Posted Date

Feb 9, 2009Estimated

Name	Class
Bracco Diagnostics, Inc	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
diabetics			Procedure: Cardiac Perfusion MRI w Vasomotor Stress
healthy controls			Procedure: Cardiac Perfusion MRI w Vasomotor Stress

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiac Perfusion MRI w Vasomotor Stress	Procedure	All participants will undergo Cardiac Perfusion MRI with Vasomotor Stress. Vasomotor Stress will include both Cold Pressor Test and Adenosine Stress Test.

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Diagnosed diabetics (less than 5 years) without documented coronary artery disease recruited from UCLA Ambulatory clinics.

Healthy controls from general population.

Sampling Method

Probability Sample

Name	Affiliation	Role
Stefan Ruehm, MD	University of California, Los Angeles	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
UCLA Radiological Sciences		Los Angeles	California	91324	United States

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

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Browse Branches

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