Stress Testing and Cardiac Magnetic Resonance
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|ClinicalTrials.gov Identifier: NCT00871260|
Recruitment Status : Recruiting
First Posted : March 30, 2009
Last Update Posted : August 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Coronary Disease||Drug: regadenoson||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||525 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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
- Major adverse cardiovascular events such as death, myocardial infarction, unstable angina, congestive heart failure, or cerebral vascular accident. [ Time Frame: 3 years ]
- Relationship between SPECT and CMR results of myocardial perfusion imaging [ Time Frame: 1 year ]
- Optimization of coronary imaging using CMR [ Time Frame: 1 year ]
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 ClinicalTrials.gov identifier (NCT number): NCT00871260
|Contact: Amit Patel, M.D.||firstname.lastname@example.org|
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Amit Patel, M.D. 773-702-1843 email@example.com|
|Principal Investigator: Amit Patel, M.D.|
|Sub-Investigator: Roberto Lang, M.D.|
|Sub-Investigator: Victor Mor-Avi, Ph.D.|
|Principal Investigator:||Amit Patel, M.D.||University of Chicago|