Actively Recruiting

Age: 35Years - 65Years
FEMALE
Healthy Volunteers
NCT00573339

Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing

Led by Cedars-Sinai Medical Center · Updated on 2023-09-01

20

Participants Needed

1

Research Sites

1230 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing

Who Can Participate

Age: 35Years - 65Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 35 to 65 years
  • No signs or symptoms of myocardial ischemia such as chest pain or abnormal stress testing
  • No cardiac risk factors by Framingham/NCEP criteria, age and BMI matched to Cardiac Syndrome X population
  • Normal exercise stress test
Not Eligible

You will not qualify if you...

  • Contraindications to cardiac MRI such as metal devices in chest, claustrophobia, or known angioedema
  • Contraindications to Adenosine or Lexiscan including heart block, sinus node disease, severe COPD/asthma, or low blood pressure (<90 mmHg)
  • Contraindications to Dobutamine including severe hypertension (≥220/120 mmHg), unstable angina, significant aortic valve stenosis, complex arrhythmias, hypertrophic obstructive cardiomyopathy, myocarditis, endocarditis, pericarditis, or uncontrolled heart failure
  • Contraindication to Gadolinium contrast including renal impairment
  • Any renal disease
  • Pregnant or lactating women
  • Inability to perform exercise due to orthopedic limitations
  • Allergy to animal dander

AI-Screening

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Trial Site Locations

Total: 1 location

1

Cedars-Sinai Women's Heart Center

Los Angeles, California, United States, 90048

Actively Recruiting

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Research Team

N

Nicole Tovar

CONTACT

B

BS WHC, MS

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing | DecenTrialz