Coronary DiseaseHawaiiNCT01284270
Lipid Rich Necrotic Core Lesion Detected by Cardiac Magnetic Resonance Imaging (CMR)
A study testing Cardiac MRI in people with Coronary Disease, run by Piedmont Healthcare.
Trial summary
The purpose of this study is to evaluate whether some features of plaques in coronary arteries predispose the heart muscle to injuries during angioplasty in patients with a narrowing in at least one of the arteries that may need a stent placed during a heart catheterization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Cardiac MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jan 2013
- 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 to 90 years
- Patients with known obstrucive coronary arterial disease for PCI in a native coronary artery
- Ability and willingness to consent and Authorization for use of personal health information (PHI)
- Ability and willingness to the required follow up procedures
Who cannot join
- An acute myocardial infarction in the vascular territory of interest.
- History of percutaneous coronary intervention in the major epicardial vessel of interest
- Lesion characteristics that preclude IVUS
- The presence of delayed enhancement in the territory of the study vessel on baseline CMR
- Patients with current history of cardiomyopathy which is known to cause enhancement on CMR study
- Patients who are considered hemodynamically unstable based on clinical assessment by the physician
Show all 26Show fewer
- Patients with Class IV congestive heart failure at time of enrollment
- Patients with poorly controlled hypertension with SBP >/= 210mmhg and/or DBP >/=140 hypertension unable to be treated, at time of enrollment
- GFR</=30 pre-procedure per institutional standards
- Patients with any known co-morbid conditions that is limiting their life expectancy to < 1year
- A known contraindication to Adenosine, including but not limited to:
- Moderate to severe hyperactive airway disease such as asthma and severe COPD
- Second or third degree AV block
- Known sinus node disease, such as sick sinus syndrome or symptomatic bradycardia
- Known hypersensitivity to Adenosine
- A known contraindication to MRI
- Electronically, magnetically, and mechanically activated implants
- Ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators, and cardiac pacemakers
- Metallic splinters/fragments in sensitive tissues including the eye, brain, spinal cord etc…
- Ferromagnetic haemostatic clips in the central nervous system
- A known contraindication to Gadolinium
- Patients with history of allergic reactions to gadolinium based contrast
- Patients with glomerular filtration rate (GFR) </= 30ml/min
- Inability or unwillingness to consent and Authorization for use of PHI
- Patients who are unwilling or unable to follow up
- Known pregnancy
About this study
Official title: High Amount of Lipid Rich Necrotic Core Lesion Identified by Pre-interventional Intravascular Ultrasound (IVUS) is Associated With High Rate of Delayed Hyper-enhancement as Detected by Contrast-enhanced Cardiac Magnetic Resonance Imaging
The purpose of this study is to evaluate whether some features of plaques in coronary arteries predispose the heart muscle to injuries during angioplasty in patients with a narrowing in at least one of the arteries that may need a stent placed during a heart catheterization. Participants undergo a cardiovascular magnetic resonance imaging (MRI) study before the heart catheterization to look for scarring in the heart muscle. During the heart catheterization, participants undergo an intravascular ultrasound (IVUS) exam to look at the make-up of the plaques before the stent placement and the investigators will measure the pressures in the arteries to look at how severe the blockage is. Within 30 days after the heart catheterization, participants will have a second MRI done to look for any new scar in the heart muscle.
- Conditions
- Coronary Disease
- Being tested
- Cardiac MRI
- Keywords
- Cardiac MRI, Plaque
- Medical subject headings
- Coronary Disease, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRIOther
Cardiac MRI
| Study group | Role | What they receive |
|---|---|---|
| All Patients | Other | All patients undergo the same study procedures Receives: Other: Cardiac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the occurrence of new areas of infarction (heart attack) in the heart muscle supplied by the vessel that was treated.
Measured: 6 months
Secondary outcomes (1)
Evaluate the occurrence of new areas of infarction (heart attack) in the heart muscle supplied by any of the 3 major blood vessels of the heart
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2013 (estimated)
Why it stopped: Study not to be initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piedmont Healthcare
- Sponsor type
- University, hospital or other
- Collaborators
- Volcano Corporation, GE Healthcare, Siemens Medical Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284270
- Sponsor's protocol ID
- Hawaii
- Acronym
- Hawaii
- Status last verified
- Jun 2011
- First submitted
- 21 Jan 2011
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Amount of Lipid Rich Necrotic Core Lesion Identified by Pre-interventional Intravascular Ultrasound (IVUS) is Associated With High Rate of Delayed Hyper-enhancement as Detected by Contrast-enhanced Cardiac Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT01284270
- Acronym / sponsor ID
- Hawaii / Hawaii
- Conditions
- Coronary Disease
- Keywords
- Cardiac MRI, Plaque
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not to be initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Piedmont HealthcareUniversity, hospital or other
- Collaborators
- Volcano Corporation, GE Healthcare, Siemens Medical Solutions
- Study start
- Jan 2011
- Primary completion
- Jan 2013 (estimated)
- First posted
- 26 Jan 2011 (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 study is to evaluate whether some features of plaques in coronary arteries predispose the heart muscle to injuries during angioplasty in patients with a narrowing in at least one of the arteries that may need a stent placed during a heart catheterization. Participants undergo a cardiovascular magnetic resonance imaging (MRI) study before the heart catheterization to look for scarring in the heart muscle. During the heart catheterization, participants undergo an intravascular ultrasound (IVUS) exam to look at the make-up of the plaques before the stent placement and the investigators will measure the pressures in the arteries to look at how severe the blockage is. Within 30 days after the heart catheterization, participants will have a second MRI done to look for any new scar in the heart muscle.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Patients | Other | Other: Cardiac MRIAll patients undergo the same study procedures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 90 years
- Patients with known obstrucive coronary arterial disease for PCI in a native coronary artery
- Ability and willingness to consent and Authorization for use of personal health information (PHI)
- Ability and willingness to the required follow up procedures
Key exclusion criteria (26 listed)
- An acute myocardial infarction in the vascular territory of interest.
- History of percutaneous coronary intervention in the major epicardial vessel of interest
- Lesion characteristics that preclude IVUS
- The presence of delayed enhancement in the territory of the study vessel on baseline CMR
- Patients with current history of cardiomyopathy which is known to cause enhancement on CMR 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 |
|---|---|---|
| Cardiac MRICardiac MRI | Other | All Patients |
Primary outcome
Evaluate the occurrence of new areas of infarction (heart attack) in the heart muscle supplied by the vessel that was treated.
Time frame: 6 months
1 secondary outcome
Evaluate the occurrence of new areas of infarction (heart attack) in the heart muscle supplied by any of the 3 major blood vessels of the heart
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac MRI in people with Coronary Disease, run by Piedmont Healthcare.
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 26 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: withdrawn, as of the sponsor's last update on 5 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Evaluate the occurrence of new areas of infarction (heart attack) in the heart muscle supplied by the vessel that was treated. (time frame: 6 months). 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 5 Sep 2013.