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Stress Testing and Cardiac Magnetic Resonance

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: NCT00871260
Recruitment Status : Unknown
Verified August 2016 by University of Chicago.
Recruitment status was:  Recruiting
First Posted : March 30, 2009
Last Update Posted : August 24, 2016
Astellas Pharma Inc
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
The purpose of this study is to better define the role of a comprehensive stress MRI (which includes myocardial perfusion imaging, optimized coronary imaging, and myocardial scar imaging) in medical practice and in patient health management. Information gathered from the healthy volunteers that participate in this study will be compared to information from the coronary artery disease patients in this study in order to help further our understanding.

Condition or disease Intervention/treatment Phase
Coronary Disease Drug: regadenoson Not Applicable

Detailed Description:

Coronary artery disease is a major cause of morbidity and mortality in the United States. Currently, the presence of physiologically significant coronary disease is most commonly diagnosed using non-invasive imaging tests such as a nuclear stress test or an echo stress test. Unfortunately, nuclear stress tests require the use of ionizing radiation and have a limited spatial resolution. On the other hand, echo stress tests are dependent of adequate imaging windows. Adenosine stress testing combined with cardiac magnetic resonance (CMR) is a rapidly evolving technique for diagnosing significant coronary disease. It does not use ionizing radiation and has excellent image quality. In a recent meta-analysis of 14 studies with a total of 1,183 patients, the sensitivity and specificity of stress CMR for detecting significant coronary disease was 91% and 81%. Additionally, 2 studies have shown that patients with a normal stress CMR study have a <1% risk of having a cardiovascular event during the ensuing year. Another important advantage to stress CMR is the ability to fully quantify myocardial blood flow which may improve the diagnostic accuracy of stress CMR. In addition to perfusion imaging, CMR can directly visualize the coronary arteries, detect extremely small myocardial infarctions, and precisely measure the left ventricular function.

Although adenosine stress CMR is a rapidly maturing test, several important challenges exist. First, many patients find it difficult to tolerate the common side effects of adenosine in the confined space of the MRI scanner. Secondly, many patients under the influence of adenosine and its side effects cannot adequately hold their breath during image acquisition making image interpretation more difficult and quantitative analysis very time consuming. Finally, because adenosine must be continuously infused during a contrast-enhanced stress CMR, 2 separate intravenous (I.V.) catheters are needed. Most of the undesirable effects of adenosine are mediated through the adenosine A(2B) and A(3) receptors; where as, its desired vasodilator effects are mediated through the A(2A) receptor. The FDA recently approved an adenosine A(2A) receptor specific stress testing agent called regadenoson which is administered as a 10 second bolus and has an improved side effect and safety profile when compared to adenosine. With its improved tolerability and ease of use, regadenoson is a more ideal stress testing agent to use with CMR.

The purpose of this study is to determine whether a comprehensive regadenoson stress cardiac magnetic resonance study which includes myocardial perfusion imaging, optimized coronary imaging, and myocardial scar imaging provides incremental prognostic information over a clinical evaluation that includes nuclear stress testing.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 525 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Stress Testing and Cardiac Magnetic Resonance
Study Start Date : April 2009
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Regadenoson

Arm Intervention/treatment
Open Label
Approximately 25 healthy volunteers will be recruited as controls, and approximately 500 patients with suspected coronary artery disease be recruited. Scan will be done with regadenoson contrast.
Drug: regadenoson
Subjects in open label group will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus) as contrast.
Other Name: Lexiscan

Primary Outcome Measures :
  1. Major adverse cardiovascular events such as death, myocardial infarction, unstable angina, congestive heart failure, or cerebral vascular accident. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Relationship between SPECT and CMR results of myocardial perfusion imaging [ Time Frame: 1 year ]
  2. Optimization of coronary imaging using CMR [ Time Frame: 1 year ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Suspected coronary artery disease
  • Symptoms of possible coronary artery disease

Exclusion Criteria:

  • Acute ST-elevation myocardial infarction
  • Second or third degree AV block
  • Severe Renal Disease (GFR <30cc/min or hemodialysis)
  • Contra-indications to MRI (i.e. ICD, pacemaker, aneurysm clip, etc)
  • Hemodynamic instability
  • Inability to provide informed consent
  • Severe claustrophobia
  • Pregnancy
  • Age <18 years

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): NCT00871260

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Contact: Amit Patel, M.D. 773-702-1843

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United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Amit Patel, M.D.    773-702-1843   
Principal Investigator: Amit Patel, M.D.         
Sub-Investigator: Roberto Lang, M.D.         
Sub-Investigator: Victor Mor-Avi, Ph.D.         
Sponsors and Collaborators
University of Chicago
Astellas Pharma Inc
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Principal Investigator: Amit Patel, M.D. University of Chicago


Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Chicago Identifier: NCT00871260    
Other Study ID Numbers: 16570B
First Posted: March 30, 2009    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016
Keywords provided by University of Chicago:
Coronary Disease
Stress Testing
Lexiscan (regadenoson)
Cardiac Magnetic Resonance Imaging
Additional relevant MeSH terms:
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Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Adenosine A2 Receptor Agonists
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs