Coronary Artery DiseasePhase 1NCT02092428
Contrast- Enhanced Whole-Heart Coronary MRA at 3.0T (Tesla)
A Phase 1 study testing Image Quality and Diagnostic Accuracy in people with Coronary Artery Disease, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Image Quality and Diagnostic Accuracy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 333 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to 1 Mar 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Contrast- Enhanced Whole-Heart Coronary Magnetic Resonance Angiography (MRA) at 3.0T
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:
Read more
- compare coronary artery imaging with and without contrast media on both healthy subjects and patients;
- 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Image Quality, Diagnostic Accuracy
- Keywords
- Coronary Magnetic Resonance Imaging, CAD, Coronary Magnetic Resonance Angiography, MRA, 3 Tesla MRI
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image QualityOther
Also called MRI with contrast, contrast-enhance MRI, non-contrast MRI, gadolinium-based contrast
The following procedures may be conducted as part of this study:
- Coronary MRI scan with no contrast
- Coronary MRI scan enhanced with a gadolinium-based contrast agent (Optimark, MultiHance, Ablavar) administered intravenously at a total dose of up to 0.2 mmol/kg
- MRI scan with an oral beta blocker (metoprolol)
- Cardiac Stress Test MRI scan with a pharmacologic stress drug; either adenosine (dosage depends on the subject's weight and is set at 140mcg/kg/min) or regadenoson (0.4mg/5ml bolus)
Determination of study drugs will be made depending upon study focus, subjects' health conditions, blood pressure, heart rate and concomitant medications. Both groups are eligible for all combinations of interventions.
Diagnostic AccuracyOther
Also called conventional x-ray angiography., contrast-enhanced MRI, non-contrast MRI, gadolinium-based contrast
Both groups are eligible for all combinations of interventions. This arm will also include collection of conventional x-ray angiography.
| Study group | Role | What they receive |
|---|---|---|
| Image Quality | Experimental | Healthy volunteers and patients will undergo non-contrast MRI or contrast-enhanced MRI to compare image quality between contrast and non-contrast scans. Receives: Other: Image Quality |
| Diagnostic Accuracy | Experimental | Healthy volunteers and patients will undergo non-contrast MRI or contrast-enhanced MRI to assess the diagnostic accuracy of coronary MRI in detecting CAD as compared to conventional x-ray angiography Receives: Other: Diagnostic Accuracy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of 3.0-T contrast-enhanced whole-heart coronary MRA in patients with suspected coronary artery disease (CAD)
sensitivity and specificity
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startApr 2011
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Principal investigator, Debiao Li, PhD, Cedars-Sinai Medical Center
- Investigators
- Debiao Li, PhD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092428
- Sponsor's protocol ID
- 23311
- Other IDs
- 5R01EB002623-07
- Status last verified
- Mar 2018
- First submitted
- 4 Mar 2014
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast- Enhanced Whole-Heart Coronary Magnetic Resonance Angiography (MRA) at 3.0T
- ClinicalTrials.gov ID
- NCT02092428
- Acronym / sponsor ID
- 23311
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Magnetic Resonance Imaging, CAD, Coronary Magnetic Resonance Angiography, MRA, 3 Tesla MRI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- Apr 2011 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 20 Mar 2014 (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.
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:
- compare coronary artery imaging with and without contrast media on both healthy subjects and patients;
- 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Image Quality | Experimental | Other: Image QualityHealthy volunteers and patients will undergo non-contrast MRI or contrast-enhanced MRI to compare image quality between contrast and non-contrast scans. |
| Diagnostic Accuracy | Experimental | Other: Diagnostic AccuracyHealthy volunteers and patients will undergo non-contrast MRI or contrast-enhanced MRI to assess the diagnostic accuracy of coronary MRI in detecting CAD as compared to conventional x-ray angiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| Image QualityAlso: MRI with contrast, contrast-enhance MRI, non-contrast MRI, gadolinium-based contrastThe following procedures may be conducted as part of this study: * Coronary MRI scan with no contrast * Coronary MRI scan enhanced with a gadolinium-based contrast agent (Optimark, MultiHance, Ablavar) administered intravenously at a total dose of up to 0.2 mmol/kg * MRI scan with an oral beta blocker (metoprolol) * Cardiac Stress Test MRI scan with a pharmacologic stress drug; either adenosine (dosage depends on the subject's weight and is set at 140mcg/kg/min) or regadenoson (0.4mg/5ml bolus) Determination of study drugs will be made depending upon study focus, subjects' health conditions, blood pressure, heart rate and concomitant medications. Both groups are eligible for all combinations of interventions. | Other | Image Quality |
| Diagnostic AccuracyAlso: conventional x-ray angiography., contrast-enhanced MRI, non-contrast MRI, gadolinium-based contrastBoth groups are eligible for all combinations of interventions. This arm will also include collection of conventional x-ray angiography. | Other | Diagnostic Accuracy |
Primary outcome
Diagnostic performance of 3.0-T contrast-enhanced whole-heart coronary MRA in patients with suspected coronary artery disease (CAD)
Time frame: one day
sensitivity and specificity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
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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. This study is not recruiting at the moment.
Debiao Li, PhD 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?
A Phase 1 study testing Image Quality and Diagnostic Accuracy in people with Coronary Artery Disease, 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 4 inclusion and 11 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: finished, as of the sponsor's last update on 23 Mar 2018. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of 3.0-T contrast-enhanced whole-heart coronary MRA in patients with suspected coronary artery disease (CAD) (time frame: one day). 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 23 Mar 2018.