Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Cedars-Sinai Medical Center
- Study ID
- NCT00573339
- Status
- Recruiting
Conditions
- Healthy
Eligibility Criteria
- Sex
- FEMALE
- Age
- 35 Years - 65 Years
- Healthy Volunteers
- Accepted
Interventions
- Cardiac MRI — OTHERup to 3 Cardiac MRI scans per participant in 1-4 months
Study Details
The purpose of this research is to understand how to apply cardiac magnetic resonance imaging (CMR) to women with small artery heart disease by looking at the CMRs of women without heart disease. The investigators will study 40 women with no heart disease to learn more about the usefulness of CMR. Women suffer more than men from this disorder of the small vessels compared to the large vessels. This results in delays in diagnosis, missed opportunities for treatment, and likely contributes to the increased death rate from heart disease in women compared to men. Current testing for small vessel disease is invasive and not performed routinely and women are often not initiated on appropriate lifesaving treatment. New imaging and noninvasive technology exists that may improve this situation. Imaging techniques such as cardiac magnetic resonance imaging (CMR) can now show the inner layers of the heart where the small vessel abnormality and myocardial ischemia exist. These techniques, while promising, have not been tested to determine if they can be used to diagnose and treat the small vessel coronary heart disease condition. They also have not been studied extensively in women without heart disease. Gadolinium, the contrast agent that will be given Intravenously to all study participants during the cardiac MRI procedure, is contraindicated to patients with renal impairment. Even though it will only be given once to each of our patients, the investigators still wanted to establish the fact that these study participants have "normal" or good renal functioning by doing BUN and Creatinine blood tests prior to the administration of this contrast agent to their system. By adding these lab tests, the investigators will be more cautious to the well-being and safety of the study participants. The investigators will be recruiting women aged 35-65 years with no known heart disease or heart disease risk factors like high blood pressure or high cholesterol. Participants will discuss the cardiac magnetic resonance procedure with a research doctor and if they agree, will fill out questionnaires related to their health, have blood draw and then undergo the CMR procedure. This can be completed in 1 or 2 visits. No follow up is needed.
Key Dates
- Start date
- May 31, 2007
- Status verified
- Aug 2023
- Primary completion
- Dec 31, 2030
- Completion
- Dec 31, 2030
Study Design
- Enrollment
- 20 participants (estimated)
Arms
- Arm: Normal Controls
Primary Outcome Measure
Cardiac MRI [ Time Frame: at study visit ]
Central Contacts
- Nicole Tovar310-248-6960
- BS WHC, MS310-423-9666
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cedars-Sinai Women's Heart Center | Los Angeles | California | 90048 | C. Noel Bairey Merz, MD (PRINCIPAL_INVESTIGATOR) |
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