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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University Hospital, Bonn
Sponsor:
Information provided by (Responsible Party):
Claas P. Naehle, University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT02054494
First received: January 31, 2014
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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.


Condition
Heart Diseases
HIV

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:
  • Native T1 Relaxation Times [ Time Frame: Measurement will be performed within 2 weeks after MRI scan ] [ Designated as safety issue: No ]
    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].


Secondary Outcome Measures:
  • Extracellular volume fraction (ECV) [ Time Frame: Measurement will be performed within 2 weeks after MRI scan ] [ Designated as safety issue: No ]

    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.



Other Outcome Measures:
  • Cardiac function and aortic distensibility [ Time Frame: Measurement will be performed within 2 weeks after MRI scan ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 100
Study Start Date: July 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02054494

Contacts
Contact: Julian A Luetkens, MD +4928828714414 quatio@web.de
Contact: Claas P Naehle, MD cp@naehle.net

Locations
Germany
University of Bonn, Dept. of Radiology Recruiting
Bonn, NRW, Germany, 53127
Contact: Claas P Naehle, MD       cp@naehle.net   
Contact: Julian A Luetkens, MD       quatio@web.de   
Principal Investigator: Claas P Naehle, MD         
Sponsors and Collaborators
University Hospital, Bonn
Investigators
Principal Investigator: Claas P Naehle, MD University of Bonn, Dept. of Radiology, Sigmund-Freud-Str. 25, 53127 Bonn, Germany
  More Information

No publications provided

Responsible Party: Claas P. Naehle, PD Dr. med., University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT02054494     History of Changes
Other Study ID Numbers: 038/13
Study First Received: January 31, 2014
Last Updated: February 3, 2014
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014