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

This study has been withdrawn prior to enrollment.
(Study not to be initiated)
Sponsor:
Collaborators:
Volcano Corporation
GE Healthcare
Siemens Medical Solutions
Information provided by:
Piedmont Healthcare
ClinicalTrials.gov Identifier:
NCT01284270
First received: January 21, 2011
Last updated: September 4, 2013
Last verified: June 2011
  Purpose

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.


Condition Intervention
Coronary Disease
Other: Cardiac MRI

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Piedmont Healthcare:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2011
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
All Patients
All patients undergo the same study procedures
Other: Cardiac MRI
Cardiac MRI

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Szilard Voros, MD, Piedmont Heart Institute
ClinicalTrials.gov Identifier: NCT01284270     History of Changes
Other Study ID Numbers: Hawaii
Study First Received: January 21, 2011
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Piedmont Healthcare:
Cardiac MRI
Plaque

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on October 19, 2014