Contrast- Enhanced Whole-Heart Coronary MRA at 3.0T (Tesla)
Information source: Cedars-Sinai Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease
Intervention: Image Quality (Other); Diagnostic Accuracy (Other)
Phase: Phase 1
Status: Recruiting
Sponsored by: Cedars-Sinai Medical Center Official(s) and/or principal investigator(s): Debiao Li, PhD, Principal Investigator, Affiliation: Cedars-Sinai Medical Center
Overall contact: Debiao Li, PhD, Phone: 310 423-7743, Email: debiao.li@cshs.org
Summary
Investigators at the Biomedical Imaging Research Institute (BIRI) at Cedars-Sinai Medical
Center have developed a Magnetic Resonance Imaging (MRI) method for imaging coronary
arteries using slow-infusion, contrast-enhanced data acquisition. This method allows faster
data acquisition and better spatial resolution.
Specific aims of this study are to:
1. compare coronary artery imaging with and without contrast media on both healthy
subjects and patients;
2. assess the accuracy of coronary MRI in detecting coronary artery disease as compared to
conventional x-ray angiography
Researchers hypothesize that contrast-enhanced MRI will improve the delineation of coronary
arteries over non-contrast-enhanced MRI and that optimized, contrast-enhanced coronary MRI
technique will accurately detect coronary artery disease (CAD) as compared to conventional
x-ray angiography.
Clinical Details
Official title: Contrast- Enhanced Whole-Heart Coronary Magnetic Resonance Angiography (MRA) at 3.0T
Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: Diagnostic performance of 3.0-T contrast-enhanced whole-heart coronary MRA in patients with suspected coronary artery disease (CAD)
Detailed description:
This is a study to compare image quality between contrast and non-contrast cardiac MR and to
evaluate the diagnostic accuracy of a cardiac MRI procedure in a patient population that
includes both healthy volunteers and a study group of patients with known CAD who are
scheduled for clinical coronary angiography within one month of signing informed consent.
Both groups are eligible for a combination of imaging tests. Subjects may receive either a
non-contrast MRI or a contrast-enhanced MRI depending upon their kidney function and study
focus. Also based upon the focus of the study at the time of the scan and to improve image
quality, a beta-blocker to lessen motion artifact in patients with higher heart rates may
be administered or patients may be asked to undergo a stress test for comparison. This is a
one-day research procedure. Studies are acquired from the approved Institutional Review
Board #25881 Cedars-Sinai Biomedical Imaging Research Registry.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion:
- All subjects must be enrolled in the IRB approved Cedars-Sinai Biomedical Imaging
Research Registry where data is collected for this analysis study.
- Male or female ≥ 18years of age
- Healthy Group -No known CAD
- CAD Group-Scheduled for clinical invasive coronary artery x-ray angiography within
one month of study participation
Exclusion:
- MR imaging is contraindicated in persons with mechanically, magnetically, or
electrically activated implants, such as cardiac pacemakers, neurostimulators, and
infusion pumps.
- Persons with ferromagnetic implants and ferromagnetic foreign bodies, such as
intracranial, aneurysm clips, shrapnel and intraocular metal chips as these could
become dislodged.
- Patients who are pregnant, nursing are implanted with intrauterine devices (IUD's)
- Persons who are in atrial fibrillation at the time of the MR scan as this could
result in poor image quality due to interference with electrocardiographic gating
necessary for image acquisition.
- Persons unable to tolerate MRI imaging secondary to an inability to lie supine or
severe claustrophobia.
- Patient with renal failure (GFR< 45)
- Allergy to animal dander or animal-instigated asthma
- Specific to Ablavar: Baseline ECG measurements and concomitant medications will be
checked on subjects who are chosen to participate in the Ablavar study, based upon
study needs. If the ECG measurements and/or medications indicate that the subject is
at high risk for arrhythmia, the subject will be excluded from the Ablavar study, but
can participate in the OptiMark/MultiHance contrast study or non-contrast study.
- Specific to beta-blocker administration: no contraindication to beta blockers. If the
subject is found to have a contraindication to beta-blockers or declines the
administration of beta-blockers the subject will be excluded from the beta-blocker
portion but can still participate in a non-contrast or contrast-enhanced scan without
beta-blocker administration.
- Specific to Regadenoson: no contraindication to regadenoson administration. If the
subject is found to have a contraindication to regadenoson the subject will be
excluded from the regadenoson portion but can still participate in a non-contrast or
contrast-enhanced scan without regadenoson stress testing.
- Specific to Adenosine: no contraindication to adenosine administration. If the subject
is found to have a contraindication to adenosine the subject will be excluded from
the adenosine portion but can still participate in a non-contrast or
contrast-enhanced scan without adenosine stress testing.
Locations and Contacts
Debiao Li, PhD, Phone: 310 423-7743, Email: debiao.li@cshs.org
Cedars-Sinai Medical Center, Los Angeles, California 90048, United States; Recruiting Debiao Li, PhD, Principal Investigator
Additional Information
Starting date: April 2011
Last updated: March 19, 2014
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