- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01089114
Cardiovascular Radiologic and Metabolic Assessment in HIV: An Investigation of Pathophysiology
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.
Visão geral do estudo
Status
Condições
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
Maryland
-
Bethesda, Maryland, Estados Unidos, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
- HIV-Infected Participants Criteria:
INCLUSION CRITERIA:
- Age 18 years or greater
- Documented HIV infection
- Willingness to have stored samples
EXCLUSION CRITERIA:
- 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
- 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:
INCLUSION CRITERIA:
- Age 18 years or greater
- Willingness to have stored samples
EXCLUSION 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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
---|
Intramyocardial triglyceride
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: Colleen M Hadigan, M.D., National Institute of Allergy and Infectious Diseases (NIAID)
Publicações e links úteis
Publicações Gerais
- Triant 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.
- Hsue 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.
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 100080
- 10-I-0080
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Doença cardiovascular
-
Mayo ClinicInscrevendo-se por conviteRisco Cardiovascular | Prevenção CardiovascularEstados Unidos
-
University of DelawareRecrutamentoFator de Risco Cardiovascular | Saúde cardiovascularEstados Unidos
-
Oregon Health and Science UniversityConcluídoDoença cardiovascular | Fatores de Risco CardiovascularEstados Unidos
-
Medical College of WisconsinAtivo, não recrutandoDoenças cardiovasculares | Fator de Risco Cardiovascular | Saúde cardiovascularEstados Unidos
-
Hospital Mutua de TerrassaConcluídoDoença cardiovascular | Fator de Risco CardiovascularEspanha
-
University of FloridaUniversity of Alabama at Birmingham; Brown UniversityConcluídoDoença cardiovascular | Influência Psicossocial na Doença CardiovascularEstados Unidos
-
Medical College of WisconsinConcluídoDoenças cardiovasculares | Fatores de Risco Cardiovascular | Saúde cardiovascular | Impacto do CantoEstados Unidos
-
Centre Hospitalier Universitaire DijonRescindidoPacientes de alto risco cardiovascular | Pacientes de Baixo Risco CardiovascularFrança
-
Shanghai 10th People's HospitalDesconhecidoPressão arterial | Fator de Risco Cardiovascular | Mortalidade geral | Mortalidade Cardiovascular | Eventos cardiovasculares | Danos em órgãos alvoChina
-
Methodist Health SystemConcluído