Ignite Creation Date:
2024-05-06 @ 2:28 AM
Last Modification Date:
2024-10-26 @ 11:19 AM
Study NCT ID:
NCT02054494
Status:
UNKNOWN
Last Update Posted:
2015-12-11
First Post:
2014-01-31
Brief Title:
T1 Mapping in HIV Patients With High and Low CD4 Cell Counts
Sponsor:
University Hospital Bonn
Organization:
University Hospital Bonn
Study Overview
Official Title:
Myocardial T1-mapping and T1-derived Extracellular Volume Fraction ECV in HIV-infection Patients With Chronic High and Low CD4 Counts and in a Healthy Control Group
Status:
UNKNOWN
Status Verified Date:
2015-12
Last Known Status:
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:
HIV-infection is associated with an increased risk for cardiovascular disease Especially patients with low CD4 counts have a higher incidence of structural heart disease Myocardial T1 relaxation time as well as T1-derived extracellular volume fraction are relatively new methods for non-invasive myocardial tissue characterization including diffuse myocardial fibrosis
In our study HIV-patients with high and low CD4 counts are examined on a 3T MRI scanner Ingenia 3T Philips Medical Best Netherlands Scanning protocol includes common SSFP sequences STIR imaging and LGE Late gadolinium enhancement All HIV patients are treated in the HIV outpatient clinic of the hospitals Internal Medicine department and have an unremarkable history of cardiac disease Patients are recruited from all over Germany In order to obtain reference values a subgroup of healthy age-matched controls is included in this study
Aim of this study is to show differences in T1- and ECV-values in the investigated subgroups In addition we also want to create cut-off values for healthy and affected myocardium in asymptomatic HIV-infected patients This study could show whether myocardial T1 mapping is a potential screening parameter for beginning heart disease as part of an HIV-infection and whether an application in routine diagnostic is reasonable
In our study HIV-patients with high and low CD4 counts are examined on a 3T MRI scanner Ingenia 3T Philips Medical Best Netherlands Scanning protocol includes common SSFP sequences STIR imaging and LGE Late gadolinium enhancement All HIV patients are treated in the HIV outpatient clinic of the hospitals Internal Medicine department and have an unremarkable history of cardiac disease Patients are recruited from all over Germany In order to obtain reference values a subgroup of healthy age-matched controls is included in this study
Aim of this study is to show differences in T1- and ECV-values in the investigated subgroups In addition we also want to create cut-off values for healthy and affected myocardium in asymptomatic HIV-infected patients This study could show whether myocardial T1 mapping is a potential screening parameter for beginning heart disease as part of an HIV-infection and whether an application in routine diagnostic is reasonable
Detailed Description:
None
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