Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-29 @ 9:51 AM
Study NCT ID:
NCT01068535
Status:
UNKNOWN
Last Update Posted:
2012-09-14
First Post:
2010-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Vascular Wall Changes by Magnetic Resonance Imaging (MRI) in Metabolic Syndrome Versus Metabolically Normal Pre-Menopausal Women: A Pilot Study
Sponsor:
University of Washington
Organization:
Study Overview
Official Title:
Early Vascular Wall Changes by MRI in Metabolic Syndrome vs. Metabolically Normal Pre-Menopausal Women: A Pilot Study
Status:
UNKNOWN
Status Verified Date:
2012-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the vascular permeability of blood vessel walls (of the carotid artery) in pre-menopausal women who have metabolic syndrome (syndrome of having at least 3/5 following features- increased abdominal fat, low good cholesterol (HDL-C), elevated fasting blood fats (triglycerides), elevated blood pressure, an elevated fasting glucose) versus those women who are normal weight and with normal cholesterol, blood fats, blood pressure, and blood sugar. We are using a novel technology to measure vascular permeability known as dynamic contrast enhancement magnetic resonance imaging (DCE-MRI). The primary variable is ktrans ratio which is a mathematically derived quantity obtained from DCE-MRI. We are trying to identify novel markers of early atherosclerosis in young women.
Detailed Description:
This study involves a phone screen \& 2 study visits:
* Screening visit, which includes a quick finger stick cholesterol, glucose, triglycerides test (cholestech) to determine qualification, waist measurement, weight. Results are provided regardless of qualification. If the volunteer qualifies, a full blood draw (approximately 45cc or 3 Tablespoons) will occur. A snack is provided once blood is drawn. Additional study visit procedures include a medical history questionnaire including menstrual history, height \& weight measurement, vital signs, and waist \& hip measurements. This study lasts up to 90 minutes.
* MRI visit (to occur within a week of screening visit) occurs once serum pregnancy \& creatinine results are received \& only if approved to continue by P.I. (e.g. negative serum pregnancy and eGFR\>60). An IV catheter is placed in the antecubital vein to administer an injection of (gadolinium) contrast medium. A coil is placed on each side of the subject's neck while laying flat on a bench, with her upper body inside the MRI scanner. The entire MRI procedure takes approximately 60 minutes.
* Screening visit, which includes a quick finger stick cholesterol, glucose, triglycerides test (cholestech) to determine qualification, waist measurement, weight. Results are provided regardless of qualification. If the volunteer qualifies, a full blood draw (approximately 45cc or 3 Tablespoons) will occur. A snack is provided once blood is drawn. Additional study visit procedures include a medical history questionnaire including menstrual history, height \& weight measurement, vital signs, and waist \& hip measurements. This study lasts up to 90 minutes.
* MRI visit (to occur within a week of screening visit) occurs once serum pregnancy \& creatinine results are received \& only if approved to continue by P.I. (e.g. negative serum pregnancy and eGFR\>60). An IV catheter is placed in the antecubital vein to administer an injection of (gadolinium) contrast medium. A coil is placed on each side of the subject's neck while laying flat on a bench, with her upper body inside the MRI scanner. The entire MRI procedure takes approximately 60 minutes.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: