Full Text View
Tabular View
No Study Results Posted
Related Studies
Endothelial Function Assessed With BOLD-MRI (EFBOLD-MRI)
This study is currently recruiting participants.
Verified by University of Calgary, February 2009
First Received: December 10, 2007   Last Updated: February 13, 2009   History of Changes
Sponsored by: University of Calgary
Information provided by: University of Calgary
ClinicalTrials.gov Identifier: NCT00575120
  Purpose

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).


Condition Intervention
Endothelial Function
Other: ischemia reperfusion

Study Type: Interventional
Study Design: Diagnostic, Open Label, Uncontrolled, Single Group Assignment
Official Title: Assessment of Endothelial Function Using Blood Oxygen Level-Dependent MRI (BOLD-MRI)

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • BOLD-MRI signal-intensity [ Time Frame: 75 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FMD PAT [ Time Frame: 75 min ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: September 2007
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
reperfusion after a 15 min. lasting cuff induced arm ischemia

Detailed Description:

This is a single center study on healthy volunteers. The subjects will be seen by the study coordinator in the SCMRC to obtain written informed consent and to assess the co-variable data (vitals, medication, history, contraindications for MRI). The study nurse will schedule two visits for endothelial function assessment that are at least one but not more than three weeks apart. Both visits are to be at the same time of day. The initial volunteer will be assigned an endothelial function assessment with MRI first followed by FMD in the endothelial function lab. Subsequent volunteers will alternate assignment to FMD or MRI first to rule out pre-conditioning effects. Simultaneous to FMD assessment, plethysmographic pulse volume will be evaluated with finger probes on the index finger of each hand. Subjects will be studied in a temperature-controlled room with minimal background distraction and in a fasting state for the previous 4 hours. Subjects will also refrain from ingesting caffeine or nicotine in these preceding 4 hours. Each study day volunteers will undergo two endothelial function assessments. The first baseline assessment takes place after a 10 minute accommodation period. The volunteer is then subjected to a 15 minute upper arm tourniquet. The second assessment takes place 15 minutes after the release of the tourniquet. This so called 'ischemia reperfusion' is known to markedly impair endothelial function for approximately one hour without affecting the early bloodflow responses to reactive hyperemia. This effect is reversible and will help to determine the actual endothelial component of measured BOLD signal changes.

One day: 2 CMR studies without contrast agent to assess endothelial function during reactive hyperemia. Each will last 15 minutes. A 15 minutes upper arm occlusion with a pressure cuff in between the 2 measurements will be applied. Another day: 2 FMD studies with ultrasound to assess endothelial function during reactive hyperemia. Each will take 15 minutes. Simultaneously a PAT hyperemic index will be measured. A 15 minutes upper arm occlusion with a pressure cuff in between the 2 measurements will be applied. Blood work (fasting glucose, creatinine, lipids, hsCRP), performed by Calgary Labs Services (CLS).

The effect of the reperfusion ischemia will be tested by individually comparing the BOLD signal change (BC) at baseline with BC after reperfusion ischemia. Since these are paired, related data a Wilcoxon rank sum test will be performed and a p value < 0.05 will be regarded as significant. The same will be done for the FMD and PAT index before and after reperfusion ischemia. FMD as the most accepted technique and will be considered as gold standard and a linear regression analysis of FMD with MBC and TBC will be performed. r2-value will be calculated and a value of > 0.25 will be considered as reasonable of > 0.5 as good correlation. If the correlation does not appear linear a Spearman's correlation test will be done. The correlations between PAT index and FMD and PAT index and TBC will also be assessed with linear regression analysis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

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

Exclusion criteria

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00575120

Contacts
Contact: Lynne Fisk (403) 944-1781 lynne.fisk@calgaryhealthregion.ca

Locations
Canada, Alberta
Stephenson CMR Centre at Foothills Medical Centre, University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Lynne Fisk     (403) 944-1781     lynne.fisk@calgaryhealthregion.ca    
Principal Investigator: Matthias Friedrich, MD            
Sub-Investigator: Oliver Strohm, MD            
Sub-Investigator: Matthias Voehringer, MD            
Sub-Investigator: Jordin Green, PhD            
Sub-Investigator: Yichun Sun, PhD            
Sponsors and Collaborators
University of Calgary
Investigators
Principal Investigator: Matthias Friedrich, MD University of Calgary
  More Information

No publications provided

Responsible Party: University of Calgary ( Matthias Friedrich, MD, Director of Stephenson CMR Centre )
Study ID Numbers: E-21003, Protocol #21003
Study First Received: December 10, 2007
Last Updated: February 13, 2009
ClinicalTrials.gov Identifier: NCT00575120     History of Changes
Health Authority: Canada: Health Canada

Keywords provided by University of Calgary:
Endothelial Function, MRI, Vascular Biology

ClinicalTrials.gov processed this record on September 11, 2009