T1 Mapping in HIV Patients With High and Low CD4+ Cell Counts
NCT ID: NCT02054494
Last Updated: 2015-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2013-07-31
2015-12-31
Brief Summary
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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 hospital's 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
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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HIV patients with high CD4+ cell counts
HIV Infection, Chronic high CD4+ cell counts (\>500 /μl), No known cardiac disease
No interventions assigned to this group
HIV patients with low CD4+ cell counts
HIV Infection, Chronic low CD4+ cell counts (\<200 /μl), No known cardiac disease
No interventions assigned to this group
Control Group
No known cardiac disease.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* no known cardiac disease
* no cardiovascular risk factors
Exclusion Criteria
* chronic kidney disease
18 Years
ALL
Yes
Sponsors
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University Hospital, Bonn
OTHER
Responsible Party
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Claas P. Naehle
PD Dr. med.
Principal Investigators
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Claas P Naehle, MD
Role: PRINCIPAL_INVESTIGATOR
University of Bonn, Dept. of Radiology, Sigmund-Freud-Str. 25, 53127 Bonn, Germany
Locations
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University of Bonn, Dept. of Radiology
Bonn, North Rhine-Westphalia, Germany
Countries
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Central Contacts
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Facility Contacts
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Claas P Naehle, MD
Role: primary
Julian A Luetkens, MD
Role: backup
Other Identifiers
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038/13
Identifier Type: -
Identifier Source: org_study_id