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

NCT02054494 | Unknown

• 1 other identifier: 038/13
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Diseases; HIV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Extracellular volume fraction (ECV)

  Measurement will be performed within 2 weeks after MRI scan

Other Outcomes (1)

• Cardiac function and aortic distensibility

  Measurement will be performed within 2 weeks after MRI scan

Study Arms (3)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• chronic HIV infection
• no known cardiac disease
• no cardiovascular risk factors

You may not qualify if:

• contraindications to MRI (e.g. metal implants)
• chronic kidney disease

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

University of Bonn, Dept. of Radiology

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Claas P Naehle, MD

  University of Bonn, Dept. of Radiology, Sigmund-Freud-Str. 25, 53127 Bonn, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julian A Luetkens, MD

CONTACT

+4928828714414; quatio@web.de

Claas P Naehle, MD

CONTACT

cp@naehle.net

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: February 4, 2014
• Study Start: July 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 11, 2015

Record last verified: 2015-12

Locations

DE (1)