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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Noel Bairey Merz, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT00573339
First received: December 13, 2007
Last updated: May 1, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Healthy
Other: Cardiac MRI

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiac Magnetic Resonance Imaging Normal Reference Control Group Testing - Ancillary Study to Coronary Endothelial Function and Microvascular Disease in Women

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Cardiac MRI [ Time Frame: at study visit ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

BUN and Creatinine blood tests


Estimated Enrollment: 20
Study Start Date: May 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Normal Controls Other: Cardiac MRI
up to 3 CMRI scans per participant in 1-4 months

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy women

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 including asthma, heart block (second and third degree) and sinus node disease, significant COPD/asthma.
  3. Contraindication to Gadolinium (renal impairment).
  4. Any renal disease.
  5. Pregnant and lactating women.
  6. Inability to perform exercise, eg. orthopedic limitations.
  7. Allergy to animal dander.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00573339

Locations
United States, California
Cedars-Sinai Women's Heart Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: C. Noel Bairey Merz, MD Cedars-Sinai Medical Center
  More Information

No publications provided

Responsible Party: Noel Bairey Merz, Director, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00573339     History of Changes
Other Study ID Numbers: IRB# 11753, 11753
Study First Received: December 13, 2007
Last Updated: May 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Cardiac
MRI
normal controls

ClinicalTrials.gov processed this record on October 19, 2014