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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Arvin Forghanian-Arani, Ph.D.	Closed-enrolling by invitation What is this? (?) "Close" Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.	Contact information: Kathy Brown (507) 538-1321 brown.kathy@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Arvin Forghanian-Arani, Ph.D.

Closed-enrolling by invitation

Contact information:

Kathy Brown

(507) 538-1321

brown.kathy@mayo.edu

More information

Publications

Publications are currently not available

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