Stress Testing and Cardiac Magnetic Resonance

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by University of Chicago
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00871260
First received: March 24, 2009
Last updated: September 4, 2013
Last verified: July 2012
  Purpose

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 Intervention
Coronary Disease
Drug: regadenoson

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Stress Testing and Cardiac Magnetic Resonance

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Major adverse cardiovascular events such as death, myocardial infarction, unstable angina, congestive heart failure, or cerebral vascular accident. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relationship between SPECT and CMR results of myocardial perfusion imaging [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Optimization of coronary imaging using CMR [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 525
Study Start Date: April 2009
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Open Label
Approximately 25 healthy volunteers will be recruited as controls, and approximately 500 patients with suspected coronary artery disease be recruited.
Drug: regadenoson
Subjects will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus)
Other Name: Lexiscan

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871260

Contacts
Contact: Amit Patel, M.D. 773-702-1843 apatel2@medicine.bsd.uchicago.edu

Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Amit Patel, M.D.    773-702-1843    apatel2@medicine.bsd.uchicago.edu   
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
Investigators
Principal Investigator: Amit Patel, M.D. University of Chicago
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00871260     History of Changes
Other Study ID Numbers: 16570B
Study First Received: March 24, 2009
Last Updated: September 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Chicago:
Coronary Disease
Stress Testing
Lexiscan (regadenoson)
Cardiac Magnetic Resonance Imaging

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Regadenoson
Adenosine A2 Receptor Antagonists
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014