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

HIV Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02054494
• Other study ID #: 038/13
• Status: Recruiting
• Phase: N/A
• First received: January 31, 2014
• Last updated: December 9, 2015
• Start date: July 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: University Hospital, Bonn
• Contact: Julian A Luetkens, MD
• Phone: +4928828714414
• Email: quatio[@]web.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Diseases
• HIV

Locations

Country	Name	City	State
Germany	University of Bonn, Dept. of Radiology	Bonn	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardiac function and aortic distensibility	Cardiac function (left ventricular endsystolic volume (LV-ESV), left ventricular enddiastolic volume (LV-EDV), and left ventricular ejection fraction (LV-EF)) will be determined offline using a dedicated software (ViewForum, Philips Healthcare, Best, The Netherlands). LV-ESV and LV-EDV will be quantified manually by tracing the endocardial borders. LV-EF is given in percentage. LV-ESV and LV-EDV are given in [ml].; Aortic Distensibility will be calculated as: Distensibility(10^-3 mmHg^-1 )=(Amax-Amin)/Amin x (Sys-Dias),where Amax and Amin represent the maximal and minimal cross-sectional area of the aorta on cine CMR images, and Sys and Dias represent the systolic and diastolic blood pressures (in millimetres of mercury), respectively.	Measurement will be performed within 2 weeks after MRI scan	No
Primary	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].	Measurement will be performed within 2 weeks after MRI scan	No
Secondary	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.	Measurement will be performed within 2 weeks after MRI scan	No