Endothelial FunctionEFBOLD-MRINCT00575120
Endothelial Function Assessed With BOLD-MRI
A study testing ischemia reperfusion in people with Endothelial Function, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Endothelial Function
- What is being tested?
- ischemia reperfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2007to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed written consent
- male gender
- age > 18 years
- fasting for 4 hours prior to the study and especially no coffee
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Stephenson CMR Centre at Foothills Medical Centre, University of Calgary
Calgary, Alberta, T2N 2T9
About this study
Official title: Assessment of Endothelial Function Using Blood Oxygen Level-Dependent MRI (BOLD-MRI)
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).
Read the 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.
- Conditions
- Endothelial Function
- Being tested
- ischemia reperfusion
- Keywords
- Endothelial Function, MRI, Vascular Biology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ischemia reperfusionOther
Also called CMR imaging study
reperfusion after a 15 min. lasting cuff induced arm ischemia
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: ischemia reperfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD-MRI signal-intensity
Measured: 75 min
Secondary outcomes (1)
FMD PAT
Measured: 75 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startSep 2007
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial FunctionStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oliver Strohm, University of Calgary
- Investigators
- Matthias Friedrich, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575120
- Sponsor's protocol ID
- E-21003
- Other IDs
- Protocol #21003
- Acronym
- EFBOLD-MRI
- Status last verified
- Oct 2011
- First submitted
- 10 Dec 2007
- Last updated
- 4 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Endothelial Function Using Blood Oxygen Level-Dependent MRI (BOLD-MRI)
- ClinicalTrials.gov ID
- NCT00575120
- Acronym / sponsor ID
- EFBOLD-MRI / E-21003
- Conditions
- Endothelial Function
- Keywords
- Endothelial Function, MRI, Vascular Biology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 18 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | No intervention | –Endothelial Function of forearm assessed by FMD, PAT, BOLD-MRI before 15 min. ischemia reperfusion of forearm |
| B | Active comparator | Other: ischemia reperfusionEndothelial Function of forearm assessed by FMD, PAT, BOLD-MRI after 15 min. ischemia reperfusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed written consent
- male gender
- age > 18 years
- fasting for 4 hours prior to the study and especially no coffee
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ischemia reperfusionAlso: CMR imaging studyreperfusion after a 15 min. lasting cuff induced arm ischemia | Other | B |
Primary outcome
BOLD-MRI signal-intensity
Time frame: 75 min
1 secondary outcome
FMD PAT
Time frame: 75 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Friedrich, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ischemia reperfusion in people with Endothelial Function, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD-MRI signal-intensity (time frame: 75 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2011.