Lipid Rich Necrotic Core Lesion Detected by Cardiac Magnetic Resonance Imaging (CMR) (NCT01284270) | Clinical Trial Compass
WithdrawnNot Applicable
Lipid Rich Necrotic Core Lesion Detected by Cardiac Magnetic Resonance Imaging (CMR)
Stopped: Study not to be initiated
0Started 2011-01
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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 kn…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate the occurrence of new areas of infarction (heart attack) in the heart muscle supplied by the vessel that was treated.