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

University Hospital Bonn (UKB)

Status: Unknown

Conditions: HIV; Heart Diseases

Study type: Observational

Funder types: Other

Identifiers

NCT02054494

038/13

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 3 patient groups

HIV patients with high CD4+ cell counts

Description:

HIV Infection, Chronic high CD4+ cell counts (\>500 /μl), No known cardiac disease

HIV patients with low CD4+ cell counts

Description:

HIV Infection, Chronic low CD4+ cell counts (\<200 /μl), No known cardiac disease

Control Group

Description:

No known cardiac disease.