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

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

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 Overview

• Status: Unknown
• Conditions: Heart Diseases; HIV

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Bonn, NRW, Germany, 53127
      • Recruiting
      • University of Bonn, Dept. of Radiology
      • Contact: Claas P Naehle, MD; Email: cp@naehle.net
      • Contact: Julian A Luetkens, MD; Email: quatio@web.de
      • Principal Investigator: Claas P Naehle, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV patients are recruted from the HIV outpatients clinic of our hospital.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
HIV patients with high CD4+ cell counts; HIV Infection, Chronic high CD4+ cell counts (>500 /μl), No known cardiac disease
HIV patients with low CD4+ cell counts; HIV Infection, Chronic low CD4+ cell counts (<200 /μl), No known cardiac disease
Control Group; No known cardiac disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Bonn
• Investigators: Principal Investigator: Claas P Naehle, MD, University of Bonn, Dept. of Radiology, Sigmund-Freud-Str. 25, 53127 Bonn, Germany

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: January 31, 2014
• First Submitted That Met QC Criteria: February 3, 2014
• First Posted (Estimate): February 4, 2014

Study Record Updates

• Last Update Posted (Estimate): December 11, 2015
• Last Update Submitted That Met QC Criteria: December 9, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: 038/13