HIVNCT01089114
Cardiovascular Radiologic and Metabolic Assessment in HIV: An Investigation of Pathophysiology
An observational study of HIV and Cardiovascular Disease, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Background: Antiretroviral therapy has increased the lifespan of people with human immunodeficiency virus (HIV), but recent research suggests that people with HIV also have an increased risk of developing cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- HIV, Cardiovascular Disease
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2010to 7 Aug 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or greater
- Documented HIV infection
- Willingness to have stored samples
- Age 18 years or greater
- Willingness to have stored samples
Who cannot join
- Subject is deemed unable to comply with requirements of study participation.
- Subjects with contraindication to MRI scanning. These contraindications include but are not limited to the following devices or conditions:
- Implanted cardiac pacemaker or defibrillator
- Cochlear implants
- Ocular foreign body (e.g. metal shavings)
- Embedded shrapnel fragments
Show all 37Show fewer
- Central nervous system aneurysm clips
- Implanted neural stimulator
- Medical infusion pumps
- Any implanted device that is incompatible with MRI.
- Subjects requiring sedation for MRI studies.
- Subjects with a condition precluding entry into scanner and acquisition of scans (e.g. morbid obesity, claustrophobia, back pain, motion disorders).
- Women who are lactating, pregnant, or actively seeking to become pregnant.
- History of severe allergic reaction to gadolinium contrast agents despite the use of premedication with an anti-histaminic and cortisone.
- Estimated glomerular filtration rate (eGFR) <60 cc/min/1.73m(2).
- Creatinine value >3.0 mg/dl
- For Coronary CTA with Iodine-Based Contrast:
- Contraindication to the use of CT contrast agents:
- Creatinine value >1.4 mg/dl or eGFR <60 cc/min/1.73m(2).
- History of multiple myeloma
- Use of metformin-containing products less than 24 hrs prior to contrast administration
- History of significant allergic reaction to CT contrast agents
- Subjects with contraindication precluding the use of beta blockers necessary to perform the coronary CTA. These include:
- Clinically significant asthma
- Active bronchospasm
- Moderate or severe chronic obstructive pulmonary disease (COPD)
- 2nd or 3rd degree AV block
- Decompensated cardiac failure
- Allergy to beta blockers
- Systolic blood pressure <100 mm Hg
- Guidelines for use of beta blocker is outlined in Appendix 1.
- Participants who are eligible for MRI but who are not eligible for cardiac CT scan will be allowed to participate in the non-CT portion of the study.
- Healthy Control Criteria:
- All of the exclusion criteria for HIV-infected participants listed above apply to healthy controls. In addition, the following exclusion criteria will also be applied to healthy controls:
- Clinically significant, systemic illness (serious infections or significant cardiac, pulmonary, hepatic, or other organ dysfunction) which in the judgment of the investigators would compromise the patient s ability to tolerate this study.
- History of or current known cardiovascular disease.
- HIV infection.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Background:
- Antiretroviral therapy has increased the lifespan of people with human immunodeficiency virus (HIV), but recent research suggests that people with HIV also have an increased risk of developing cardiovascular disease. To better understand the prevalence and effects of heart disease in people with HIV, researchers are interested in comparing heart imaging and metabolism studies to see if there are differences between HIV-positive and HIV-negative people.
Read more
Objectives:
- To study metabolism and heart function in people with HIV compared with healthy HIV-negative volunteers.
Eligibility:
- Individuals at least 18 years of age who either have been diagnosed with HIV or are healthy HIV-negative volunteers.
Design:
- Participants will be evaluated with a physical exam, detailed medical history, and routine blood and urine tests including HIV testing.
- Participants will have the following imaging scans:
- Cardiac magnetic resonance imaging (MRI) to study the health of the heart and blood vessels
- Magnetic resonance spectroscopy (MRS) of the heart, liver, and skeletal muscle
- Cardiac computerized tomography (CT) scan to measure calcium levels in the heart and nearby arteries
- Dual-energy x-ray absorptiometry (DEXA) scan to measure body fat and muscle mass.
- Stable isotope infusion to evaluate how the body processes fat (which will require an overnight stay before the test)
- Participants will also have blood tests, an echocardiogram, and an electrocardiogram to evaluate heart function.
Read the detailed description
HIV is now a chronic infection as patients with access to antiretroviral therapy have significantly improved life expectancies. Patients with HIV also have an increased risk of cardiovascular disease. Thus, cardiovascular disease is an important potential co-morbidity for patients living with HIV. The current proposal will perform a detailed cardiovascular assessment using state-of-the-art imaging techniques to evaluate intramyocardial lipid as well as coronary artery disease and myocardial function in a cohort of 100 HIV infected patients and 30 healthy volunteers as controls. This is an early exploratory cross-sectional study designed to both assess the burden of disease and apply novel techniques in this unique population.
- Conditions
- HIV, Cardiovascular Disease
- Keywords
- Cardiac Imaging, MR Spectroscopy, HIV, Lipid Metabolism, HIV Infection, Cardiovascular Disease, HIV Infections
- Medical subject headings
- Cardiovascular Diseases, HIV Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Intramyocardial triglyceride
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2010 (estimated)
- Study start8 Mar 2010
- Study completion7 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Time perspective
- Other
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Colleen M Hadigan, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089114
- Sponsor's protocol ID
- 100080
- Other IDs
- 10-I-0080
- Status last verified
- 7 Aug 2015
- First submitted
- 17 Mar 2010
- Last updated
- 14 Feb 2018
- Results posted
- No
Publications
DAD Study Group; Friis-Moller N, Reiss P, Sabin CA, Weber R, Monforte Ad, El-Sadr W, Thiebaut R, De Wit S, Kirk O, Fontas E, Law MG, Phillips A, Lundgren JD. Class of antiretroviral drugs and the risk of myocardial infarction. N Engl J Med. 2007 Apr 26;356(17):1723-35. doi: 10.1056/NEJMoa062744.
PubMed 17460226Triant VA, Lee H, Hadigan C, Grinspoon SK. Increased acute myocardial infarction rates and cardiovascular risk factors among patients with human immunodeficiency virus disease. J Clin Endocrinol Metab. 2007 Jul;92(7):2506-12. doi: 10.1210/jc.2006-2190. Epub 2007 Apr 24.
PubMed 17456578Hsue PY, Hunt PW, Ho JE, Farah HH, Schnell A, Hoh R, Martin JN, Deeks SG, Bolger AF. Impact of HIV infection on diastolic function and left ventricular mass. Circ Heart Fail. 2010 Jan;3(1):132-9. doi: 10.1161/CIRCHEARTFAILURE.109.854943. Epub 2009 Nov 20.
PubMed 19933410
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Radiologic and Metabolic Assessment in HIV: An Investigation of Pathophysiology
- ClinicalTrials.gov ID
- NCT01089114
- Acronym / sponsor ID
- 100080
- Conditions
- HIV, Cardiovascular Disease
- Keywords
- Cardiac Imaging, MR Spectroscopy, HIV, Lipid Metabolism, HIV Infection, Cardiovascular Disease, HIV Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 8 Mar 2010
- Study completion
- 7 Aug 2015
- First posted
- 18 Mar 2010 (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.
Background:
- Antiretroviral therapy has increased the lifespan of people with human immunodeficiency virus (HIV), but recent research suggests that people with HIV also have an increased risk of developing cardiovascular disease. To better understand the prevalence and effects of heart disease in people with HIV, researchers are interested in comparing heart imaging and metabolism studies to see if there are differences between HIV-positive and HIV-negative people.
Objectives:
- To study metabolism and heart function in people with HIV compared with healthy HIV-negative volunteers.
Eligibility:
- Individuals at least 18 years of age who either have been diagnosed with HIV or are healthy HIV-negative volunteers.
Design:
- Participants will be evaluated with a physical exam, detailed medical history, and routine blood and urine tests including HIV testing.
- Participants will have the following imaging scans:
- Cardiac magnetic resonance imaging (MRI) to study the health of the heart and blood vessels
- Magnetic resonance spectroscopy (MRS) of the heart, liver, and skeletal muscle
- Cardiac computerized tomography (CT) scan to measure calcium levels in the heart and nearby arteries
- Dual-energy x-ray absorptiometry (DEXA) scan to measure body fat and muscle mass.
- Stable isotope infusion to evaluate how the body processes fat (which will require an overnight stay before the test)
- Participants will also have blood tests, an echocardiogram, and an electrocardiogram to evaluate heart function.
Detailed description
HIV is now a chronic infection as patients with access to antiretroviral therapy have significantly improved life expectancies. Patients with HIV also have an increased risk of cardiovascular disease. Thus, cardiovascular disease is an important potential co-morbidity for patients living with HIV. The current proposal will perform a detailed cardiovascular assessment using state-of-the-art imaging techniques to evaluate intramyocardial lipid as well as coronary artery disease and myocardial function in a cohort of 100 HIV infected patients and 30 healthy volunteers as controls. This is an early exploratory cross-sectional study designed to both assess the burden of disease and apply novel techniques in this unique population.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or greater
- Documented HIV infection
- Willingness to have stored samples
- Age 18 years or greater
- Willingness to have stored samples
Key exclusion criteria (37 listed)
- Subject is deemed unable to comply with requirements of study participation.
- Subjects with contraindication to MRI scanning. These contraindications include but are not limited to the following devices or conditions:
- Subjects requiring sedation for MRI studies.
- Subjects with a condition precluding entry into scanner and acquisition of scans (e.g. morbid obesity, claustrophobia, back pain, motion disorders).
- Women who are lactating, pregnant, or actively seeking to become pregnant.
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
Intramyocardial triglyceride
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Background: PubMed 17460226DAD Study Group; Friis-Moller N, Reiss P, Sabin CA, Weber R, Monforte Ad, El-Sadr W, Thiebaut R, De Wit S, Kirk O, Fontas E, Law MG, Phillips A, Lundgren JD. Class of antiretroviral drugs and the risk of myocardial infarction. N Engl J Med. 2007 Apr 26;356(17):1723-35. doi: 10.1056/NEJMoa062744.
- Background: PubMed 17456578Triant VA, Lee H, Hadigan C, Grinspoon SK. Increased acute myocardial infarction rates and cardiovascular risk factors among patients with human immunodeficiency virus disease. J Clin Endocrinol Metab. 2007 Jul;92(7):2506-12. doi: 10.1210/jc.2006-2190. Epub 2007 Apr 24.
- Background: PubMed 19933410Hsue PY, Hunt PW, Ho JE, Farah HH, Schnell A, Hoh R, Martin JN, Deeks SG, Bolger AF. Impact of HIV infection on diastolic function and left ventricular mass. Circ Heart Fail. 2010 Jan;3(1):132-9. doi: 10.1161/CIRCHEARTFAILURE.109.854943. Epub 2009 Nov 20.
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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.
Colleen M Hadigan, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
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 HIV and Cardiovascular Disease, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 5 inclusion and 37 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: finished, as of the sponsor's last update on 14 Feb 2018. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intramyocardial triglyceride. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01089114, which also lists 3 linked publications.
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 14 Feb 2018.