Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06555211
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Cardio and Renovascular Effects of Isometric Exercise in the Healthy Human Measured by PETCT and MRI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Cardio and Renovascular Effects of Static Muscle Work in the Healthy Human - Measured With Finapres and Positron Emission Tomography PET Using 15-oxygen Labeled Water as Tracer Compared to Magnetic Resonance MR
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized crossover study aims to validate measurements of renal perfusion in healthy males with PETCT using 15-oxygen labeled water as tracer against the validated multiparametric MRI technique
The study will determine
Total renal blood flow and regional renal perfusion at baseline rest and during isometric muscle exercise of the upper arm using PETCT with 15-oxygen labeled water as a tracer and MRI
The coefficient of variation of renal blood flow and regional renal perfusion measurements at baseline and during isometric muscle exercise of the upper arm using PETCT with 15-oxygen labeled water as a tracer and MRI
Regional renal oxygenation and oxygen extraction at baseline and during isometric muscle exercise of the upper arm using MRI
The coefficient of variation on regional renal oxygenation and oxygen extraction measurements at baseline and during isometric muscle exercise of the upper arm using MRI
The study will determine
Total renal blood flow and regional renal perfusion at baseline rest and during isometric muscle exercise of the upper arm using PETCT with 15-oxygen labeled water as a tracer and MRI
The coefficient of variation of renal blood flow and regional renal perfusion measurements at baseline and during isometric muscle exercise of the upper arm using PETCT with 15-oxygen labeled water as a tracer and MRI
Regional renal oxygenation and oxygen extraction at baseline and during isometric muscle exercise of the upper arm using MRI
The coefficient of variation on regional renal oxygenation and oxygen extraction measurements at baseline and during isometric muscle exercise of the upper arm using MRI
Detailed Description:
Measuring tissue perfusion with PETCT using 15-oxygen labeled water is routinely used as a non-invasive tool to examine cerebral and myocardial perfusion With a 100 tissue extraction 15-oxygen labeled water is gold standard
The aim of the present study is to validate renal perfusion measurements with PETCT using 15-oxygen labeled water as tracer against the validated multiparametric MRI technique
Once validated the imaging technique will be beneficial in examining vascular damage in the kidneys caused by different renal diseases
This is a randomized crossover study where each participant will participate in 1 study day
Ten healthy male participants in the age group 20-60 years are screened and randomized and expected to complete the present study Informed consent is obtained before the screening meeting
All participants consume a controlled diet with fixed salt intake corresponding to a daily intake of 50-70 mmol 2 mmolkg sodium for 4 days before the experiment On the fourth day 24-hour urine collection will be performed Throughout the 4 day period water intake will be ad libitum and physical activity will not be allowed
Each participant will undergo both PETCT and MRI separated by around 15 hour
Total renal blood flow and regional renal perfusion are measured repeatedly altogether 5 times with both PETCT and MRI Renal oxygenation and oxygen extraction are measured repeatedly 5 times as well using MRI The 5 measurements consist of 2 at baseline rest 2 during isometric exercise handgrip and 1 during recovery rest
Isometric muscle exercise is conducted by squeezing a handgrip coupled to a dynamometer This increases sympathetic nervous activity leading to preglomerular vasoconstriction
The aim of the present study is to validate renal perfusion measurements with PETCT using 15-oxygen labeled water as tracer against the validated multiparametric MRI technique
Once validated the imaging technique will be beneficial in examining vascular damage in the kidneys caused by different renal diseases
This is a randomized crossover study where each participant will participate in 1 study day
Ten healthy male participants in the age group 20-60 years are screened and randomized and expected to complete the present study Informed consent is obtained before the screening meeting
All participants consume a controlled diet with fixed salt intake corresponding to a daily intake of 50-70 mmol 2 mmolkg sodium for 4 days before the experiment On the fourth day 24-hour urine collection will be performed Throughout the 4 day period water intake will be ad libitum and physical activity will not be allowed
Each participant will undergo both PETCT and MRI separated by around 15 hour
Total renal blood flow and regional renal perfusion are measured repeatedly altogether 5 times with both PETCT and MRI Renal oxygenation and oxygen extraction are measured repeatedly 5 times as well using MRI The 5 measurements consist of 2 at baseline rest 2 during isometric exercise handgrip and 1 during recovery rest
Isometric muscle exercise is conducted by squeezing a handgrip coupled to a dynamometer This increases sympathetic nervous activity leading to preglomerular vasoconstriction
Study Oversight
Has Oversight DMC:
None
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?:
None