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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00573339
Recruitment Status : Recruiting
First Posted : December 14, 2007
Last Update Posted : November 21, 2017
Information provided by (Responsible Party):
Noel Bairey Merz, Cedars-Sinai Medical Center

December 13, 2007
December 14, 2007
November 21, 2017
May 2007
December 2018   (Final data collection date for primary outcome measure)
Cardiac MRI [ Time Frame: at study visit ]
Not Provided
Complete list of historical versions of study NCT00573339 on Archive Site
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Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing
Cardiac Magnetic Resonance Imaging Normal Reference Control Group Testing - Ancillary Study to Coronary Endothelial Function and Microvascular Disease in Women

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.

The women will be consented and enrolled. They will:

  1. fill out baseline demographic and health history questionnaires;
  2. have an exercise treadmill test (ETT) To rule out any underlying ischemic heart disease;
  3. undergo rest-stress CMR testing (up to 3 scans);
  4. peripheral arterial tonometry; and
  5. have blood drawn for hematocrit, blood urea nitrogen (BUN),creatinine, and research protein quantitation with mass spectrometry and enzyme-linked immunosorbent assay (ELISA) for sensitive quantitation of cardiovascular biomarkers.
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   None Retained
BUN and Creatinine blood tests
Non-Probability Sample
Healthy women
Other: Cardiac MRI
up to 3 Cardiac MRI scans per participant in 1-4 months
Normal Controls
Intervention: Other: Cardiac MRI
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2018
December 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Women without signs and symptoms of myocardial ischemia (chest pain, abnormal stress testing, abnormal noninvasive testing).
  2. No cardiac risk factors by Framingham/NCEP criteria, age and BMI matched to the Cardiac Syndrome X population, and a normal exercise stress test.

Exclusion Criteria:

  1. Contraindications to CMR testing (metal devices in chest, claustrophobia, known angioedema).
  2. Contraindication to Adenosine or Lexiscan (regadenoson) including heart block (second and third degree) and sinus node disease, significant COPD/asthma, or systemic hypotension (<90 mmHg).
  3. Contraindication to Dobutamine including severe systemic hypertension (≥ 220/120 mmHg), unstable angina, significant aortic valve stenosis, complex cardiac arrhythmia including uncontrolled atrial fibrillation, hypertrophic obstructive cardiomyopathy, myocarditis, endocarditis, pericarditis, or uncontrolled congestive heart failure.
  4. Contraindication to Gadolinium (renal impairment).
  5. Any renal disease.
  6. Pregnant and lactating women.
  7. Inability to perform exercise, eg. orthopedic limitations.
  8. Allergy to animal dander.
Sexes Eligible for Study: Female
35 Years to 65 Years   (Adult)
Contact: Ying Mou, PhD 310-248-7669
Contact: Sophie Yoo, MS 424-315-4306
United States
IRB# 11753
Not Provided
Plan to Share IPD: Yes
Noel Bairey Merz, Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
Not Provided
Principal Investigator: C. Noel Bairey Merz, MD Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
November 2017