T1 Mapping in HIV Patients With High and Low CD4+ Cell Counts

N/AUnknownNCT02054494

University Hospital, Bonn100 enrolled

Overview

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 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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Heart Diseases HIV

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * chronic HIV infection * no known cardiac disease * no cardiovascular risk factors Exclusion Criteria: * contraindications to MRI (e.g. metal implants) * chronic kidney disease

Outcomes

Primary Outcomes

Native T1 Relaxation Times

T1 relaxation times will be directly obtained form the T1 maps through ROI analysis. T1 maps will be analyzed using a segmental approach. T1 relaxation times are given in \[ms\].

Time frame: Measurement will be performed within 2 weeks after MRI scan

Secondary Outcomes

Extracellular volume fraction (ECV)

Hematocrit corrected ECV will be calculated using pre- and post-contrast T1 values for myocardium and blood pool using following formula: ECV= (1⁄T1 "myocardium post contrast"-1⁄T1 "myocadium pre contrast")/(1⁄T1 "blood post contrast"-1⁄ T1 "blood pre contrast") x (1-hematocrit). ECV is given in percentage.