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

Coronary Disease Clinical Trial

— Hawaii  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01284270
• Other study ID #: Hawaii
• Status: Withdrawn
• Phase: N/A
• First received: January 21, 2011
• Last updated: September 4, 2013
• Start date: January 2011

Study information

• Verified date: June 2011
• Source: Piedmont Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Intervention

Other:
• Cardiac MRI
Cardiac MRI

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Piedmont Healthcare	GE Healthcare, Siemens Medical Solutions, Volcano Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the occurrence of new areas of infarction (heart attack) in the heart muscle supplied by the vessel that was treated.		6 months	No
Secondary	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	No