Coronary Artery DiseaseNCT01986868
Identification of Adverse Plaque Characteristics by Coronary MR Angiography
A study testing Coronary MR Angiography (CMRA) in people with Coronary Artery Disease, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
This is a pilot study to determine whether coronary magnetic resonance angiography(CMRA)can identify adverse plaque characteristics (buildup of fat, cholesterol, calcium, and other substances found in the blood) seen on coronary computed tomography angiography(CCTA) and evaluate whether there is a relationship between… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Coronary MR Angiography (CMRA)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to 24 Jan 2018
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Ability to comprehend and sign informed consent
- Presence of a non-calcified or mixed plaque without high-grade stenosis in the left main or a proximal coronary artery segment AND at least one APC present in this plaque by CCTA (defined as LAP with <30 Hounsfield units or PR with ≥10% increase in the maximal vessel diameter within the plaque as compared to a proximal reference segment as previously described10).
Who cannot join
- High-grade stenosis (≥50% stenosis of the left main artery or ≥70% stenosis of another proximal coronary segment);
- Coronary artery stent in the segment with the reference plaque
- Possible pregnancy
- Glomerular filtration rate <45 ml/min
- More than 90 days between CCTA and CMRA study
- Any significant arrhythmia (e.g. atrial fibrillation, frequent ectopy)
Show all 14Show fewer
- Significant asthma
- History of 2nd or 3rd degree heart block
- Allergy or known intolerance to beta-blockers
- Use of phosphodiesterase inhibitor (e.g. Viagra) within the last 48 hours
- Rapid heart rate (heart rate ≥90 beats/minute)
- Severe aortic stenosis (Aortic valve area <1.0 cm2 or mean gradient >30 mmHg)
- Systolic blood pressure <100 mmHg
- Other contraindication to MRI, including metallic implants (valve replacement, pacemaker, implantable cardiac defibrillator, metallic spine material), intracranial clips, metallic fragments in eyes, and claustrophobia
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: Identification of Adverse Plaque Characteristics by Coronary Magnetic Resonance Angiography
This is a pilot study to determine whether coronary magnetic resonance angiography(CMRA)can identify adverse plaque characteristics (buildup of fat, cholesterol, calcium, and other substances found in the blood) seen on coronary computed tomography angiography(CCTA) and evaluate whether there is a relationship between the adverse plaque characteristics and the presence of coronary artery wall inflammation.
Read the detailed description
This pilot study will examine 20 stable patients who have undergone a clinically-indicated coronary computed tomography angiography (CCTA) for suspected Coronary Artery Disease. They will be invited to undergo a research coronary Magnetic Resonance Imaging scan with contrast(CMRA). Based upon the subject's heart rate, a beta blocker may be administered as its use has been shown to be effective in producing better images as it widens the arteries.
Researchers will use newly developed non-invasive coronary MRA techniques to compare information shown on the research CMRA with the clinical CCTA. While CCTA has been demonstrated to be able to provide data on adverse plaque characteristics (APC's), the ability of CMRA to evaluate these features is not established.
- Conditions
- Coronary Artery Disease
- Being tested
- Coronary MR Angiography (CMRA)
- Keywords
- Coronary Magnetic Resonance Angiography, CMRA, MRI with contrast, MultiHance, Optimark, Gadolinium-based contrast, MRA, MR angiography
- 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.
Coronary MR Angiography (CMRA)Other
Also called MRI with contrast, MultiHance, Optimark, Gadolinium-based contrast
Stable patients who have undergone a clinically indicated CCTA study for suspected Coronary Artery Disease will undergo a research CMRA with contrast (Multihance or Optimark)total dose of up to 0.2 mmol/kg IV. Possible administration of oral beta-blocker (metoprolol)intravenous doses of 5mg IV metoprolol may be given every 2 minutes up to a maximal dose of 15 mg IV.
| Study group | Role | What they receive |
|---|---|---|
| Coronary MR Angiography (CMRA) | Other | Coronary MR Angiography(CMRA). A gadolinium-based contrast (Optimark or MultiHance) will be administered as well as a beta blocker which will be assigned based upon heart rate. Receives: Other: Coronary MR Angiography (CMRA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse plaque characteristics present on CMRA
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 posted19 Nov 2013 (estimated)
- Study startApr 2012
- Primary completion24 Jan 2018
- Study completion24 Jan 2018
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel S. Berman, Cedars-Sinai Medical Center
- Investigators
- Daniel S Berman, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986868
- Sponsor's protocol ID
- 27850
- Status last verified
- Jan 2021
- First submitted
- 12 Nov 2013
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Adverse Plaque Characteristics by Coronary Magnetic Resonance Angiography
- ClinicalTrials.gov ID
- NCT01986868
- Acronym / sponsor ID
- 27850
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Magnetic Resonance Angiography, CMRA, MRI with contrast, MultiHance, Optimark, Gadolinium-based contrast, MRA, MR angiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Apr 2012 (actual)
- Primary completion
- 24 Jan 2018 (actual)
- Study completion
- 24 Jan 2018 (actual)
- First posted
- 19 Nov 2013 (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.
This is a pilot study to determine whether coronary magnetic resonance angiography(CMRA)can identify adverse plaque characteristics (buildup of fat, cholesterol, calcium, and other substances found in the blood) seen on coronary computed tomography angiography(CCTA) and evaluate whether there is a relationship between the adverse plaque characteristics and the presence of coronary artery wall inflammation.
Detailed description
This pilot study will examine 20 stable patients who have undergone a clinically-indicated coronary computed tomography angiography (CCTA) for suspected Coronary Artery Disease. They will be invited to undergo a research coronary Magnetic Resonance Imaging scan with contrast(CMRA). Based upon the subject's heart rate, a beta blocker may be administered as its use has been shown to be effective in producing better images as it widens the arteries.
Researchers will use newly developed non-invasive coronary MRA techniques to compare information shown on the research CMRA with the clinical CCTA. While CCTA has been demonstrated to be able to provide data on adverse plaque characteristics (APC's), the ability of CMRA to evaluate these features is not established.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary MR Angiography (CMRA) | Other | Other: Coronary MR Angiography (CMRA)Coronary MR Angiography(CMRA). A gadolinium-based contrast (Optimark or MultiHance) will be administered as well as a beta blocker which will be assigned based upon heart rate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- Ability to comprehend and sign informed consent
- Presence of a non-calcified or mixed plaque without high-grade stenosis in the left main or a proximal coronary artery segment AND at least one APC present in this plaque by CCTA (defined as LAP with <30 Hounsfield units or PR with ≥10% increase in the maximal vessel diameter within the plaque as compared to a proximal reference segment as previously described10).
Key exclusion criteria (14 listed)
- High-grade stenosis (≥50% stenosis of the left main artery or ≥70% stenosis of another proximal coronary segment);
- Coronary artery stent in the segment with the reference plaque
- Possible pregnancy
- Glomerular filtration rate <45 ml/min
- More than 90 days between CCTA and CMRA study
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 |
|---|---|---|
| Coronary MR Angiography (CMRA)Also: MRI with contrast, MultiHance, Optimark, Gadolinium-based contrastStable patients who have undergone a clinically indicated CCTA study for suspected Coronary Artery Disease will undergo a research CMRA with contrast (Multihance or Optimark)total dose of up to 0.2 mmol/kg IV. Possible administration of oral beta-blocker (metoprolol)intravenous doses of 5mg IV metoprolol may be given every 2 minutes up to a maximal dose of 15 mg IV. | Other | Coronary MR Angiography (CMRA) |
Primary outcome
Adverse plaque characteristics present on CMRA
Time frame: one day
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 27 Jan 2021.
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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.
Daniel S Berman, 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?
A study testing Coronary MR Angiography (CMRA) 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 3 inclusion and 14 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 27 Jan 2021. 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?
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?
Adverse plaque characteristics present on CMRA (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 27 Jan 2021.