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

NCT00573339 | Recruiting

• 1 other identifier: IRB# 11753
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Healthy

Keywords

Cardiac; MRI; normal controls

Outcome Measures

Primary Outcomes (1)

• Cardiac MRI

  at study visit

Study Arms (1)

Normal Controls

Other: Cardiac MRI

Interventions

Cardiac MRI OTHER

up to 3 Cardiac MRI scans per participant in 1-4 months

Normal Controls

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy women

You may qualify if:

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

You may not qualify if:

• Contraindications to CMR testing (metal devices in chest, claustrophobia, known angioedema).
• 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).
• 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.
• Contraindication to Gadolinium (renal impairment).
• Any renal disease.
• Pregnant and lactating women.
• Inability to perform exercise, eg. orthopedic limitations.
• Allergy to animal dander.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Women's Heart Center

Los Angeles, California, 90048, United States

RECRUITING

Biospecimen

Retention: NONE RETAINED

BUN and Creatinine blood tests

Study Officials

• C. Noel Bairey Merz, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Tovar

CONTACT

310-248-6960; nicole.tovar@cshs.org

BS WHC, MS

CONTACT

310-423-9666; bswhc.research@cshs.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 13, 2007
• First Posted: December 14, 2007
• Study Start: May 1, 2007
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)