A Study to Evaluate the Impact of Menopause on Cardiac Stiffness Acquired with Magnetic Resonance Elastography

Overview

Información sobre este estudio

The purpose of this study is to evaluate the effects of menopause transition on myocardial stiffness in healthy female subjects without a history of heart disease who are expected to be close to the average age of menopause transition (~51 years), in the 48-53 year age range. All eligible subjects will undergo two study visits that will include a cardiac MRI/MRE exam, echocardiography imaging and blood test.

The purpose of this aim is to characterize the relationship between the serum estradiol level and myocardial stiffness changes in young women (<46) on estradiol replacement therapy after bilateral oophorectomy.  Subjects will be recruited from the ongoing “Impact of Individualized Estrogen Therapy on Cardiovascular Disease Risk Parameters in Young Women after Bilateral Oophorectomy: A Randomized Controlled Trial” study.  These subjects will undergo two cardiac MRI/MRE exams one with-in +/- three weeks of their bilateral oophorectomy surgery and with-in +/- three weeks of their 12 month follow-up appointment.

 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

Aim 1

  • Healthy, normal subjects around the approximate age of menopause (~ 51).
  • In the 40-60 year age range without known cardiac conditions.
  • Without symptoms referable to the heart, namely chest pain or shortness of breath. 

Aim 2

  • Subjects from the ongoing “Impact of Individualized Estrogen Therapy on Cardiovascular Disease Risk Parameters in Young Women after Bilateral Oophorectomy: A Randomized Controlled Trial” study.  
  • Subjects in this cohort will be between 21 and 45 years of age, at the onset of the study.
  • Willingness to return for follow up exam +/- 3 weeks of 12 month post-operative follow-up appointment.
  • These subjects will undergo two cardiac MRI/MRE exams one with-in +/- three weeks of their bilateral oophorectomy surgery and with-in +/- three weeks of their 12 month follow-up appointment.

Exclusion Criteria: 

  • Known cardiac conditions, symptoms referable to the heart; namely, chest pain or shortness of breath. 
  • For Magnetic Resonance Imaging (MRI) participants:
    • Absolute contraindications to MRI including pacemaker, AICD device, cochlear implant, VP shunt, aneurysm clip, deep brain stimulator, or severe claustrophobia;
    • Body weight over 500 pounds (or 226 kilograms), and chest/waist/hip circumference over 160 cm, due to MRI system limit (70-cm bore, < 400 lbs.).

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Arvin Forghanian-Arani, Ph.D.

Cerrado; inscripción por invitación

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El estudio no está abierto para todos los que cumplen con los criterios de elegibilidad, sino solamente para las personas que el equipo del estudio ha invitado a participar.

Contact information:

Kathy Brown

(507) 538-1321

brown.kathy@mayo.edu

More information

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CLS-20516785

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