HealthyNCT00573339
Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing
An observational study of Healthy, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cardiac MRI
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy women
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Women's Heart Center
Los Angeles, California, 90048
Nicole Tovar, 310-248-6960, nicole.tovar@cshs.org
BS WHC, MS, 310-423-9666, bswhc.research@cshs.org
About this study
Official title: 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.
Read more
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.
Read the detailed description
The women will be consented and enrolled. They will:
- fill out baseline demographic and health history questionnaires;
- have an exercise treadmill test (ETT) To rule out any underlying ischemic heart disease;
- undergo rest-stress CMR testing (up to 3 scans);
- peripheral arterial tonometry; and
- 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.
- measure central arterial stiffness by noninvasive pulse wave analysis (PWA) using SphygmoCor (done up to 3 times-once at each MRI visit).
- Conditions
- Healthy
- Being tested
- Cardiac MRI
- Keywords
- Cardiac, MRI, normal controls
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRIOther
up to 3 Cardiac MRI scans per participant in 1-4 months
| Study group | Role | What they receive |
|---|---|---|
| Normal Controls | Not described Receives: Other: Cardiac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac MRI
Measured: at study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2007 (estimated)
- Study startMay 2007
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noel Bairey Merz, Cedars-Sinai Medical Center
- Investigators
- C. Noel Bairey Merz, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573339
- Sponsor's protocol ID
- IRB# 11753
- Status last verified
- Aug 2023
- First submitted
- 13 Dec 2007
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Magnetic Resonance Imaging Normal Reference Control Group Testing - Ancillary Study to Coronary Endothelial Function and Microvascular Disease in Women
- ClinicalTrials.gov ID
- NCT00573339
- Acronym / sponsor ID
- IRB# 11753
- Conditions
- Healthy
- Keywords
- Cardiac, MRI, normal controls
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 14 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The women will be consented and enrolled. They will:
- fill out baseline demographic and health history questionnaires;
- have an exercise treadmill test (ETT) To rule out any underlying ischemic heart disease;
- undergo rest-stress CMR testing (up to 3 scans);
- peripheral arterial tonometry; and
- 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.
- measure central arterial stiffness by noninvasive pulse wave analysis (PWA) using SphygmoCor (done up to 3 times-once at each MRI visit).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal Controls | – | Other: Cardiac MRI |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy women
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac MRIup to 3 Cardiac MRI scans per participant in 1-4 months | Other | Normal Controls |
Primary outcome
Cardiac MRI
Time frame: at study visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
C. Noel Bairey Merz, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Tovar (310-248-6960, nicole.tovar@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac MRI (time frame: at study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023; AzTrials last refreshed its copy on 26 Oct 2026.