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Technical Development of Cardiovascular Magnetic Resonance Imaging

29 de março de 2021 atualizado por: National Heart, Lung, and Blood Institute (NHLBI)

This study will explore new ways of using magnetic resonance imaging (MRI) to evaluate the heart and blood vessels of patients with cardiovascular disease, including better detection of myocardial infarction (heart attack) and blockage of heart and leg arteries.

Patients 18 years of age and older with cardiovascular disease may be eligible for this study.

All participants will have magnetic resonance imaging of the heart. MRI uses a magnetic field and radio waves to show structural and chemical changes in tissues. For the procedure, the patient lies on a table surrounded by a metal cylinder (the scanner). A 'gadolinium contrast' material may be injected into the patient s vein during part of the study to brighten the images. Patients wear earplugs during the scan to muffle loud knocking sounds caused by the electrical switching of the magnetic fields. They will be asked to hold their breath intermittently for 5 to 20 seconds during the scan. They will be monitored with an electrocardiogram (EKG) during the procedure and will be in contact by intercom at all times with the person performing the scan. Patients can request to stop the study and come out of the scanner at any time. The procedure may last from 30 to 90 minutes. An echocardiogram a test that uses sound waves to produce pictures of the heart and blood vessels-may be done to confirm the MRI findings. In addition, patients may undergo one or more of the following optional studies:

  • Dobutamine stress MRI - This test uses dobutamine-a medicine that simulates exercise by increasing heart rate and heart function-to detect blockages in the coronary arteries (vessels that supply oxygen and nutrients to the heart) and locate areas of the heart that are permanently damaged, perhaps by a previous heart attack. For this test, MRI pictures of the heart are taken before, during and after administration of dobutamine. Gadolinium may be injected during part of the study to brighten the images. An EKG will be used to monitor the heart during the procedure.
  • Vasodilator MRI - The procedure and objectives of this test are the same as those described for dobutamine stress MRI, except that this study uses dipyridamole or adenosine. These drugs dilate blood vessels, causing increased blood flow to the heart.
  • Plethysmography MRI - This test determines the presence and severity of narrowing in arteries that supply blood to the leg. Blockage of these vessels often causes pain while walking. This study will compare plethysmography MRI with venous occlusion plethysmography, an older method of measuring blood flow in the legs. For venous occlusion plethysmography, a large blood pressure cuff is placed around the upper leg and a strain gauge (thin elastic band) is placed around the calf. The pressure cuff is inflated very tightly for 5 minutes to block blood flow to the leg, and another pressure cuff over the ankle is also inflated. When the large cuff is deflated, blood rushes to the leg, a smaller cuff is inflated to a low pressure, and the strain gauge measures the maximum blood flow to the leg for 1 or 2 more minutes. This procedure is done once or twice outside the MRI scanner and once or twice inside the scanner. The scans are performed as described above for the dobutamine and vasodilator studies. The strain gauge is not used for plethysmography MRI the MRI pictures are used to measure flow.

Visão geral do estudo

Descrição detalhada

The purpose of this protocol is to allow development and testing of new MRI techniques suitable for evaluating patients with cardiovascular disease. Since such technical development work often depends on preliminary studies in healthy volunteers, the protocol also recruits healthy subjects. This protocol will provide the framework for technical development scans in patients with cardiovascular disease.

Tipo de estudo

Observacional

Inscrição (Real)

8781

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Maryland
      • Bethesda, Maryland, Estados Unidos, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike
      • Bethesda, Maryland, Estados Unidos, 20814
        • Suburban Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 100 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Patients with cardiovascular diseases and healthy subjects 18 years of age or older were recruited within this protocol. The exclusion criteria were developed from standard clinical practice but were more restrictive to err on the side of safety. Recruitment was via referral from local physicians. In addition, advertisements were placed in the "Washington Post". Finally, the protocol was listed on the NIH websites.

A patient could participate in any combination of these tests/procedures. Clinical judgment was used to determine the number of tests/procedures suitable for a given patient. Specifically, the responsible physician avoided prolonging tests/procedures in patients in accordance with the patient's clinical status.

Descrição

-INCLUSION CRITERIA:

  1. Inclusion Criteria for All Arms of the Protocol:

    • Subjects 18 years of age or older
    • Written informed consent

    EXCLUSION CRITERIA:

  2. Exclusion Criteria for All Arms of the Protocol:

    • Patients with a contraindication to MRI scanning will be excluded. These contraindications include patients with the following devices:

      • Central nervous system aneurysm clips;
      • Implanted neural stimulator;
      • Implanted cardiac pacemaker or defibrillator;
      • Cochlear implant;
      • Ocular foreign body (e.g. metal shavings);
      • Implanted Insulin pump;
      • Metal shrapnel or bullet.
  3. In addition, the following patient groups will be excluded:

    • Pregnant women (Patients who are uncertain as to whether they are pregnant will be required to have a screening urine or blood pregnancy test)
    • Patients with active symptoms of myocardial ischemia occurring despite maximally tolerated doses of oral antianginal therapy and intravenous nitroglycerin
  4. Furthermore, the following patient groups will be excluded from studies involving the administration of MRI contrast agents:

    • lactating women unless they are willing to discard breast milk for 24 hours after receiving gadolinium
    • renal disease (estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73 m(2) body surface area)

    The eGFR will be used to estimate renal function if reported by the laboratory, or as reported by NIH Clinical Center or Suburban Hospital or other clinically certified laboratories. Otherwise, estimated glomerular filtration rate (eGFR) can be based on the Modification of Diet in Renal Disease (MDRD) study equation (see below) in subjects with stable renal function. This formula is not applicable to patients with acute renal insufficiency:

    eGFR (ml/min/1.73 m(2)) equal to 175 times (serum creatinine)-1.154 times (age)-0.203 times 0.742 (if the subject is female) times1.212 (if the subject is black)

  5. Additional Exclusion Criteria for Dobutamine, or Vasodilator Stress MRI:

    • Myocardial infarction within 48 hours
    • Uncontrolled congestive heart failure
    • Severe hypertension (SBP greater than 200, DBP greater than 110) (exclusion only for dobutamine and bicycle)
    • Atrial fibrillation. This exclusion only applies to Dobutamine stress.
    • Frequent PVC s (more than 1 every 10 heart beats or non-sustained ventricular tachycardia (greater than 4 beat runs) or ongoing sustained ventricular tachycardia. This exclusion only applies to Dobutamine and Bicycle stress
    • Patients with narrow angle glaucoma and known or suspected prostatic obstruction will not receive atropine
  6. Additional Exclusion Criteria for PET/MR perfusion scans

    • Pregnant patients
    • Patients that are breast feeding

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
Participants with cardiovascular diseases
Patients may receive an intravenous injection of gadobutrol (Gadavist) not to exceed 0.2 mmol/kg of Gd per bolus injection and per examination.
Investigational or research MRI coils may be used in the protocol. The coils are noninvasive devices external to the body. The coils act as antennae to receive small radiofrequency signals out of the body. Coils of the type we use are used daily in clinical MRI practice.
Healthy Participants
Patients may receive an intravenous injection of gadobutrol (Gadavist) not to exceed 0.2 mmol/kg of Gd per bolus injection and per examination.
Investigational or research MRI coils may be used in the protocol. The coils are noninvasive devices external to the body. The coils act as antennae to receive small radiofrequency signals out of the body. Coils of the type we use are used daily in clinical MRI practice.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
examine the rate of major cardiovascular events (MACE) defined as cardiac death, non- fatal myocardial infarction, cerebrovascular / transient ischemic attack, and revascularization in patients undergoing stress or rest cardiac MRI
Prazo: Ongoing
examine the rate of major cardiovascular events (MACE) defined as cardiac death, non- fatal myocardial infarction, cerebrovascular / transient ischemic attack, and revascularization in patients undergoing stress or rest cardiac MRI and to relate these events to the extent of ischemia and infarction seen on the MRI exams
Ongoing

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Arlene Sirajuddin, M.D., National Heart, Lung, and Blood Institute (NHLBI)

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

26 de novembro de 2001

Conclusão Primária (Real)

5 de abril de 2018

Conclusão do estudo (Real)

19 de novembro de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

27 de novembro de 2001

Enviado pela primeira vez que atendeu aos critérios de CQ

27 de novembro de 2001

Primeira postagem (Estimativa)

28 de novembro de 2001

Atualizações de registro de estudo

Última Atualização Postada (Real)

30 de março de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de março de 2021

Última verificação

22 de dezembro de 2020

Mais Informações

Termos relacionados a este estudo

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Sim

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