Lipid Rich Necrotic Core Lesion Detected by Cardiac Magnetic Resonance Imaging (CMR)

NCT01284270 | Withdrawn

• 1 other identifier: Hawaii
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Coronary Disease

Keywords

Cardiac MRI; Plaque

Outcome Measures

Primary Outcomes (1)

• Evaluate the occurrence of new areas of infarction (heart attack) in the heart muscle supplied by the vessel that was treated.

  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

  6 months

Study Arms (1)

All Patients

OTHER

All patients undergo the same study procedures

Other: Cardiac MRI

Interventions

Cardiac MRI OTHER

Cardiac MRI

All Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Piedmont Healthcare: lead
• Volcano Corporation: collaborator
• GE Healthcare: collaborator
• Siemens Medical Solutions: collaborator

MeSH Terms

Conditions

Coronary Disease; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 21, 2011
• First Posted: January 26, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2013
• Last Updated: September 5, 2013

Record last verified: 2011-06