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Clinical Trials/NCT01284270
NCT01284270
Withdrawn
Not Applicable

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

Piedmont Healthcare0 sitesJanuary 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Disease
Sponsor
Piedmont Healthcare
Primary Endpoint
Evaluate the occurrence of new areas of infarction (heart attack) in the heart muscle supplied by the vessel that was treated.
Status
Withdrawn
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
January 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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)

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