Comprehensive Evaluation of Ischemic Heart Disease Using MRI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01234870
Recruitment Status : Completed
First Posted : November 4, 2010
Results First Posted : September 26, 2014
Last Update Posted : September 26, 2014
Astellas Pharma US, Inc.
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Information provided by (Responsible Party):
James Carr, Northwestern University

Brief Summary:
The purpose of the study is to assess the diagnostic performance of fully automated motion corrected (MC) first pass myocardial perfusion MRI, compared to the original non-corrected first pass myocardial perfusion images in a cohort of patients with suspected ischemic heart disease, using coronary angiography as the reference standard. It is expected that this improved comprehensive protocol for cardiac MRI be accurate at detecting significant coronary artery disease and may obviate the need for other more expensive and invasive diagnostic tests currently used.

Condition or disease Intervention/treatment Phase
Heart Disease, Ischemic Atherosclerosis, Coronary Drug: Gadolinium Drug: Adenosine Phase 2 Phase 3

Detailed Description:

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)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

Drug Information available for: Adenosine
U.S. FDA Resources

Arm Intervention/treatment
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.
Drug: Gadolinium
Other Name: Magnevist, Bayer HealthCare Pharmaceuticals
Drug: Adenosine

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Under an Institutional Committee on Human Research board approved protocol 80 patients with a suspected myocardial ischemic disease recruited from the cardiac cath laboratory will be recruited in this prospective study. Volunteers will be recruited for the purpose of protocol development and will not be included in analysis. All subjects will be screened for glomerular filtration rate (GFR) within 24 hours before the exam. All patients must have a GFR > 30 mL/min/1.73m2 to be part of the study.

All subjects will be selected following the Nephrogenic Systemic Fibrosis (NSF) guidelines. All dialysis patients or end-stage renal disease patients with a creatinine clearance of < 30 mL/min will not be selected for the study to avoid NSF. Patients with GFR < 60 ml/min but >30 ml/min will receive a reduced dose of Gadolinium contrast (0.1 ml/kg).

Exclusion Criteria:

  1. Age <18 years;
  2. Known contraindication to MR imaging (such as pacemaker placement, magnetic implants, etc);
  3. Claustrophobia;
  4. Inability to perform an adequate breath-hold for imaging,
  5. Inability to provide informed consent;
  6. all subjects will be will be screened for GFR within 24 hours before the exam and subjects presenting with GFR < 30 ml/min will be excluded;
  7. Pregnant and lactating women;
  8. Patients with hypersensitivity to gadolinium contrast agents, metoprolol, adenosine, or nitroglycerin;
  9. Contra indication for Adenosine

    1. 2nd- or 3rd-degree atrioventricular block (except in patients with a functioning artificial pacemaker)
    2. Sinus node disease (except in patients with a functioning artificial


    3. Unstable angina
    4. Acute myocardial infarction
    5. Known or suspected bronchoconstrictive or bronchospastic lung

      disease (e.g., asthma)

    6. Hypersensitivity to adenosine
    7. Caffeine within 12-24 hours
    8. Theophylline and Dipyridamole products within 24 hours.
  10. Contra indication for Metoprolol

    1. sinus bradycardia
    2. heart block greater than first degree
    3. Cardiac Failure
    4. Bronchospastic Disease
  11. Contra indication for Nitroglycerin

    1. Early myocardial infarction, severe anemia, increased intracranial pressure, and those with a known hypersensitivity to nitroglycerin.

b .Administration of Nitrostat (nitroglycerin tablets, USP) is contraindicated in patients who are using Viagra® since Viagra has been shown to potentiate the hypotensive effects of organic nitrates.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01234870

United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Astellas Pharma US, Inc.
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Principal Investigator: James C Carr, MD Northwestern University

Responsible Party: James Carr, Director of Cardiovascular Imaging, Department of Radiology,Associate Professor of Radiology and Medicine, Northwestern University Feinberg School of Medicine, Northwestern University Identifier: NCT01234870     History of Changes
Other Study ID Numbers: CR1_STU00006013
ASCA-9J02 ( Other Grant/Funding Number: Astellas Pharma Global Development, Inc )
First Posted: November 4, 2010    Key Record Dates
Results First Posted: September 26, 2014
Last Update Posted: September 26, 2014
Last Verified: September 2014

Keywords provided by James Carr, Northwestern University:
Myocardial Perfusion Imaging
Magnetic Resonance Imaging

Additional relevant MeSH terms:
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Coronary Disease
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action