Endothelial Function Assessed With BOLD-MRI

NCT00575120 | Completed DMC

• 2 other identifiers: E-21003Protocol #21003
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the applicability of a new SSFP-based BOLD sensitive MRI sequence in evaluating endothelial function. Endothelial function will be tested in a setting of reactive hyperemia in the forearm. In a setting of ischemia-reperfusion, the effect of transient endothelial function impairment will be tested. Comparison with endothelial function assessment by brachial ultrasound (FMD) and finger tip plethysmography (PAT) will be incorporated. Hypothesis: BOLD-MRI is a feasible tool to assess endothelial function in the human forearm during reactive hyperemia. There is significant correlation to established flow-mediated dilation (FMD).

Conditions

Endothelial Function

Keywords

Endothelial Function, MRI, Vascular Biology

Outcome Measures

Primary Outcomes (1)

• BOLD-MRI signal-intensity

  75 min

Secondary Outcomes (1)

• FMD PAT

  75 min

Study Arms (2)

A

NO INTERVENTION

Endothelial Function of forearm assessed by FMD, PAT, BOLD-MRI before 15 min. ischemia reperfusion of forearm

B

ACTIVE COMPARATOR

Endothelial Function of forearm assessed by FMD, PAT, BOLD-MRI after 15 min. ischemia reperfusion

Other: ischemia reperfusion

Interventions

ischemia reperfusion OTHER

reperfusion after a 15 min. lasting cuff induced arm ischemia

Also known as: CMR imaging study

B

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed written consent
• male gender
• age \> 18 years
• fasting for 4 hours prior to the study and especially no coffee

You may not qualify if:

• Contraindications for MRI
• female gender
• known cardiovascular disease including: CHD, congestive heart failure, peripheral vascular disease
• known cardiovascular risk factors : smoking, diabetes mellitus, hypertension, hyperlipidemia
• Current vasoactive medication : Beta-blockers, Ca-Antagonists, ACE-Inhibitors, ARB, Phosphodiesterase inhibitors
• concomitant serious medical condition
• unreliability as a volunteer or inability or unwillingness to complete the study and the second day of examination

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Stephenson CMR Centre at Foothills Medical Centre, University of Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

Study Officials

• Matthias Friedrich, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adunct Research Associate Professor

Study Record Dates

• First Submitted: December 10, 2007
• First Posted: December 18, 2007
• Study Start: September 1, 2007
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 4, 2011

Record last verified: 2011-10

Locations

CA (1)