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

September 4, 2013 updated by: Piedmont Healthcare

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: All Patients
All patients undergo the same study procedures
Other: Cardiac MRI
Cardiac MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Piedmont Healthcare

Collaborators

GE Healthcare
Siemens Medical Solutions
Volcano Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

January 1, 2013

Study Registration Dates

First Submitted

January 21, 2011

First Submitted That Met QC Criteria

January 25, 2011

First Posted (Estimate)

January 26, 2011

Study Record Updates

Last Update Posted (Estimate)

September 5, 2013

Last Update Submitted That Met QC Criteria

September 4, 2013

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAWAII

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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