Heart DiseasesNCT02054494
T1 Mapping in HIV Patients With High and Low CD4+ Cell Counts
An observational study of Heart Diseases and HIV, run by University Hospital, Bonn at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Diseases, HIV
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2013to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: HIV patients are recruted from the HIV outpatients clinic of our hospital.
Who may be able to join
- chronic HIV infection
- no known cardiac disease
- no cardiovascular risk factors
Who cannot join
- contraindications to MRI (e.g. metal implants)
- chronic kidney disease
Trial locations and contacts
1 site in 1 country.
Claas P Naehle, MD contact
Germany1 site, 1 recruiting
- Recruiting
University of Bonn, Dept. of Radiology
Bonn, North Rhine-Westphalia, 53127
Claas P Naehle, MD, cp@naehle.net
Julian A Luetkens, MD, quatio@web.de
About this study
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
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
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: Measurement will be performed within 2 weeks after MRI scan
Secondary outcomes (1)
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.
Measured: Measurement will be performed within 2 weeks after MRI scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startJul 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claas P. Naehle, University Hospital, Bonn
- Investigators
- Claas P Naehle, MD, Principal investigator, University of Bonn, Dept. of Radiology, Sigmund-Freud-Str. 25, 53127 Bonn, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054494
- Sponsor's protocol ID
- 038/13
- Status last verified
- Dec 2015
- First submitted
- 31 Jan 2014
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02054494
- Acronym / sponsor ID
- 038/13
- Conditions
- Heart Diseases, HIV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 4 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HIV patients are recruted from the HIV outpatients clinic of our hospital.
Key inclusion criteria (3 listed)
- chronic HIV infection
- no known cardiac disease
- no cardiovascular risk factors
Key exclusion criteria (2 listed)
- contraindications to MRI (e.g. metal implants)
- chronic kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Native T1 Relaxation Times
Time frame: Measurement will be performed within 2 weeks after MRI scan
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].
1 secondary outcome
Extracellular volume fraction (ECV)
Time frame: Measurement will be performed within 2 weeks after MRI scan
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claas P Naehle, MD contact
Claas P Naehle, MD principal investigator
University of Bonn, Dept. of Radiology, Sigmund-Freud-Str. 25, 53127 Bonn, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Diseases and HIV, run by University Hospital, Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julian A Luetkens, MD (+4928828714414, quatio@web.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Native T1 Relaxation Times (time frame: Measurement will be performed within 2 weeks after MRI scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2015.