Using cardiac MRI to study healthy women for heart disease insights
Cardiac Magnetic Resonance Imaging Normal Reference Control Group Testing - Ancillary Study to Coronary Endothelial Function and Microvascular Disease in Women
Cedars-Sinai Medical Center · NCT00573339
This study is testing how cardiac MRI can help us learn more about heart health in healthy women to improve diagnosis and treatment for women with small artery heart disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 35 Years to 65 Years |
| Sex | Female |
| Sponsor | Cedars-Sinai Medical Center (other) |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT00573339 on ClinicalTrials.gov |
What this trial studies
This research aims to apply cardiac magnetic resonance imaging (CMR) to women without heart disease to establish a normal reference control group. The study will enroll 40 healthy women who will undergo various assessments, including exercise treadmill tests and CMR scans, to gather data on cardiovascular health. By comparing these results to those of women with small artery heart disease, the study seeks to enhance understanding of CMR's utility in diagnosing and treating this condition. The findings may lead to improved noninvasive diagnostic techniques for women suffering from small vessel heart disease.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy women without any signs or symptoms of heart disease.
Not a fit: Patients with existing heart disease or those who do not meet the inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better diagnostic methods for small artery heart disease in women, potentially improving treatment outcomes.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using advanced imaging techniques for cardiovascular assessment.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Los Angeles, California
- Cedars-Sinai Women's Heart Center — Los Angeles, California, United States (RECRUITING)
Study contacts
- Principal investigator: C. Noel Bairey Merz, MD — Cedars-Sinai Medical Center
- Study coordinator: Nicole Tovar
- Email: nicole.tovar@cshs.org
- Phone: 310-248-6960
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Healthy, Cardiac, MRI, normal controls