Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 35 - 65 |
| Updated: | 12/19/2018 |
| Start Date: | May 2007 |
| End Date: | December 2019 |
| Contact: | Ying Mou, PhD |
| Email: | ying.mou@cshs.org |
| Phone: | 310-248-7669 |
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.
(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.
6. measure central arterial stiffness by noninvasive pulse wave analysis (PWA) using
SphygmoCor (done up to 3 times-once at each MRI visit).
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.
6. measure central arterial stiffness by noninvasive pulse wave analysis (PWA) using
SphygmoCor (done up to 3 times-once at each MRI visit).
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.
We found this trial at
1
site
Los Angeles, California 90048
Principal Investigator: C. Noel Bairey Merz, MD
Phone: 310-248-7669
Click here to add this to my saved trials
