Comprehensive Evaluation of Ischemic Heart Disease Using MRI
|ClinicalTrials.gov Identifier: NCT01234870|
Recruitment Status : Completed
First Posted : November 4, 2010
Results First Posted : September 26, 2014
Last Update Posted : September 26, 2014
|Condition or disease||Intervention/treatment||Phase|
|Heart Disease, Ischemic Atherosclerosis, Coronary||Drug: Gadolinium Drug: Adenosine||Phase 2 Phase 3|
Coronary heart disease is the leading cause of death and disability in the US, accounting for about one-third of all deaths in subjects over age 35.
With the development of newer Magnetic Resonance Imaging (MRI) techniques, such as faster pulse sequences and parallel imaging, cardiac MRI has become a routine tool for the evaluation and detection of myocardial ischemic disease. First pass myocardial perfusion (FPMP) using MRI is increasingly being used to assess ischemic heart disease. MRI offers the advantages of spatial resolution sufficient to differentiate between subendocardial and subepicardial perfusion; shorter examination time and also lack of ionizing radiation. Left ventricle cine gradient echo imaging can be used to assess regional ventricular function. Left ventricular myocardial viability can also be easily assessed at the same time in order to determine the amount of viable left ventricular myocardium and the percentage of irreversibly scarred myocardium by delayed enhanced images. Viability imaging is usually added to the perfusion protocol to increase specificity by allowing detection of fixed perfusion defects, which represent scar. The ultimate cardiac MRI protocol would be to combine both of these imaging strategies with a reliable and accurate coronary Magnetic Resonance Angiography(MRA) technique, such that obstructive coronary artery disease could be evaluated comprehensively at the same time. If all of these techniques can be combined together in a single study, it may be feasible to finally achieve a "one stop shop" for cardiac Magnetic Resonance Imaging.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comprehensive Evaluation of Ischemic Heart Disease Using MRI|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Experimental: Ischemic heart disease patients
Patients with suspected ischemic heart disease prospectively recruited for first pass myocardial perfusion MRI. All subject to receive Gadolinium infusion of 0.075 mmol/kg at rate of 4 ml/sec. Adenosine administered at a rate of 0.14 mg/kg/min for a duration of 4 minutes to induce stress.
Other Name: Magnevist, Bayer HealthCare PharmaceuticalsDrug: Adenosine
- Magnetic Resonance Image Quality Rating [ Time Frame: Cross sectional study; magnetic resonance images were obtained on all patients using two different acquisition methods. ]The purpose of the study is to assess the incremental value of diagnostic performance using a fully-automated, motion-corrected (MC) first pass myocardial perfusion image acquisition protocol compared to images obtained under a non-corrected, breath-hold, shallow-breathing first pass myocardial perfusion image acquisition protocol in patients with suspected ischemic heart disease. The MR images resulting from two different image acquisition techniques, including Non-Corrected Breath-Hold Shallow-Breathing and Motion-Corrected, were assessed independently by two radiologists (average of 7 years of experience in reading cardiac MRI) using the American Heart Association modified 16 segment model and were evaluated using a four point Likert scale (1 = poor, 2 = fair, 3 = good, and 4 = excellent) for image quality
- Number of Participants With Adverse Events to Demonstrate Feasibility of a Comprehensive Cardiac Magnetic Resonance Imaging Protocol [ Time Frame: 14 days ]Adverse events relating to administration of adenosine during a coronary heart disease comprehensive cardiac MRI study.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01234870
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||James C Carr, MD||Northwestern University|