Stress Testing and Cardiac Magnetic Resonance

NCT00871260 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 16570B
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Disease

Keywords

Coronary Disease; Stress Testing; Lexiscan (regadenoson); Cardiac Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiovascular Events

  Major adverse cardiovascular events, such as death, myocardial infarction, unstable angina, congestive heart failure, or cerebral vascular accident.

  3 years

Secondary Outcomes (2)

• Relationship Between SPECT and CMR Results of Myocardial Perfusion Imaging

  1 year

• Optimization of Coronary Imaging Using CMR

  1 year

Study Arms (1)

Open Label

OTHER

Approximately 25 healthy volunteers will be recruited as controls. Scan will be done with regadenoson contrast.

Drug: regadenoson

Interventions

regadenoson DRUG

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.

Also known as: Lexiscan

Open Label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Chicago: lead
• Astellas Pharma Inc: collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (21)

• Hachamovitch R, Berman DS, Shaw LJ, Kiat H, Cohen I, Cabico JA, Friedman J, Diamond GA. Incremental prognostic value of myocardial perfusion single photon emission computed tomography for the prediction of cardiac death: differential stratification for risk of cardiac death and myocardial infarction. Circulation. 1998 Feb 17;97(6):535-43. doi: 10.1161/01.cir.97.6.535.

  PMID: 9494023 BACKGROUND

• McCrohon JA, Lyne JC, Rahman SL, Lorenz CH, Underwood SR, Pennell DJ. Adjunctive role of cardiovascular magnetic resonance in the assessment of patients with inferior attenuation on myocardial perfusion SPECT. J Cardiovasc Magn Reson. 2005;7(2):377-82. doi: 10.1081/jcmr-200053627.

  PMID: 15881517 BACKGROUND

• Nandalur KR, Dwamena BA, Choudhri AF, Nandalur MR, Carlos RC. Diagnostic performance of stress cardiac magnetic resonance imaging in the detection of coronary artery disease: a meta-analysis. J Am Coll Cardiol. 2007 Oct 2;50(14):1343-53. doi: 10.1016/j.jacc.2007.06.030. Epub 2007 Sep 17.

  PMID: 17903634 BACKGROUND

• Jahnke C, Nagel E, Gebker R, Kokocinski T, Kelle S, Manka R, Fleck E, Paetsch I. Prognostic value of cardiac magnetic resonance stress tests: adenosine stress perfusion and dobutamine stress wall motion imaging. Circulation. 2007 Apr 3;115(13):1769-76. doi: 10.1161/CIRCULATIONAHA.106.652016. Epub 2007 Mar 12.

  PMID: 17353441 BACKGROUND

• Ingkanisorn WP, Kwong RY, Bohme NS, Geller NL, Rhoads KL, Dyke CK, Paterson DI, Syed MA, Aletras AH, Arai AE. Prognosis of negative adenosine stress magnetic resonance in patients presenting to an emergency department with chest pain. J Am Coll Cardiol. 2006 Apr 4;47(7):1427-32. doi: 10.1016/j.jacc.2005.11.059. Epub 2006 Mar 20.

  PMID: 16580532 BACKGROUND

• Schwitter J, Wacker CM, van Rossum AC, Lombardi M, Al-Saadi N, Ahlstrom H, Dill T, Larsson HB, Flamm SD, Marquardt M, Johansson L. MR-IMPACT: comparison of perfusion-cardiac magnetic resonance with single-photon emission computed tomography for the detection of coronary artery disease in a multicentre, multivendor, randomized trial. Eur Heart J. 2008 Feb;29(4):480-9. doi: 10.1093/eurheartj/ehm617. Epub 2008 Jan 21.

  PMID: 18208849 BACKGROUND

• Hachamovitch R, Hayes SW, Friedman JD, Cohen I, Berman DS. Comparison of the short-term survival benefit associated with revascularization compared with medical therapy in patients with no prior coronary artery disease undergoing stress myocardial perfusion single photon emission computed tomography. Circulation. 2003 Jun 17;107(23):2900-7. doi: 10.1161/01.CIR.0000072790.23090.41. Epub 2003 May 27.

  PMID: 12771008 BACKGROUND

• Wang L, Jerosch-Herold M, Jacobs DR Jr, Shahar E, Detrano R, Folsom AR; MESA Study Investigators. Coronary artery calcification and myocardial perfusion in asymptomatic adults: the MESA (Multi-Ethnic Study of Atherosclerosis). J Am Coll Cardiol. 2006 Sep 5;48(5):1018-26. doi: 10.1016/j.jacc.2006.04.089. Epub 2006 Aug 17.

  PMID: 16949496 BACKGROUND

• Patel AR, Epstein FH, Kramer CM. Evaluation of the microcirculation: advances in cardiac magnetic resonance perfusion imaging. J Nucl Cardiol. 2008 Sep-Oct;15(5):698-708. doi: 10.1016/j.nuclcard.2008.07.002. No abstract available.

  PMID: 18761273 BACKGROUND

• Sakuma H, Ichikawa Y, Chino S, Hirano T, Makino K, Takeda K. Detection of coronary artery stenosis with whole-heart coronary magnetic resonance angiography. J Am Coll Cardiol. 2006 Nov 21;48(10):1946-50. doi: 10.1016/j.jacc.2006.07.055. Epub 2006 Oct 31.

  PMID: 17112982 BACKGROUND

• Wagner A, Mahrholdt H, Holly TA, Elliott MD, Regenfus M, Parker M, Klocke FJ, Bonow RO, Kim RJ, Judd RM. Contrast-enhanced MRI and routine single photon emission computed tomography (SPECT) perfusion imaging for detection of subendocardial myocardial infarcts: an imaging study. Lancet. 2003 Feb 1;361(9355):374-9. doi: 10.1016/S0140-6736(03)12389-6.

  PMID: 12573373 BACKGROUND

• Bellenger NG, Davies LC, Francis JM, Coats AJ, Pennell DJ. Reduction in sample size for studies of remodeling in heart failure by the use of cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2000;2(4):271-8. doi: 10.3109/10976640009148691.

  PMID: 11545126 BACKGROUND

• Lieu HD, Shryock JC, von Mering GO, Gordi T, Blackburn B, Olmsted AW, Belardinelli L, Kerensky RA. Regadenoson, a selective A2A adenosine receptor agonist, causes dose-dependent increases in coronary blood flow velocity in humans. J Nucl Cardiol. 2007 Jul;14(4):514-20. doi: 10.1016/j.nuclcard.2007.02.016.

  PMID: 17679059 BACKGROUND

• Ding S, Wolff SD, Epstein FH. Improved coverage in dynamic contrast-enhanced cardiac MRI using interleaved gradient-echo EPI. Magn Reson Med. 1998 Apr;39(4):514-9. doi: 10.1002/mrm.1910390403.

  PMID: 9543412 BACKGROUND

• Christian TF, Rettmann DW, Aletras AH, Liao SL, Taylor JL, Balaban RS, Arai AE. Absolute myocardial perfusion in canines measured by using dual-bolus first-pass MR imaging. Radiology. 2004 Sep;232(3):677-84. doi: 10.1148/radiol.2323030573. Epub 2004 Jul 29.

  PMID: 15284436 BACKGROUND

• Mor-Avi V, Akselrod S, David D, Keselbrener L, Bitton Y. Myocardial transit time of the echocardiographic contrast media. Ultrasound Med Biol. 1993;19(8):635-48. doi: 10.1016/0301-5629(93)90070-5.

  PMID: 8134968 BACKGROUND

• Jerosch-Herold M, Wilke N, Stillman AE. Magnetic resonance quantification of the myocardial perfusion reserve with a Fermi function model for constrained deconvolution. Med Phys. 1998 Jan;25(1):73-84. doi: 10.1118/1.598163.

  PMID: 9472829 BACKGROUND

• Spuentrup E, Katoh M, Buecker A, Manning WJ, Schaeffter T, Nguyen TH, Kuhl HP, Stuber M, Botnar RM, Gunther RW. Free-breathing 3D steady-state free precession coronary MR angiography with radial k-space sampling: comparison with cartesian k-space sampling and cartesian gradient-echo coronary MR angiography--pilot study. Radiology. 2004 May;231(2):581-6. doi: 10.1148/radiol.2312030451. Epub 2004 Mar 24.

  PMID: 15044745 BACKGROUND

• Diamond GA, Forrester JS. Analysis of probability as an aid in the clinical diagnosis of coronary-artery disease. N Engl J Med. 1979 Jun 14;300(24):1350-8. doi: 10.1056/NEJM197906143002402.

  PMID: 440357 BACKGROUND

• Kim RJ, Fieno DS, Parrish TB, Harris K, Chen EL, Simonetti O, Bundy J, Finn JP, Klocke FJ, Judd RM. Relationship of MRI delayed contrast enhancement to irreversible injury, infarct age, and contractile function. Circulation. 1999 Nov 9;100(19):1992-2002. doi: 10.1161/01.cir.100.19.1992.

  PMID: 10556226 BACKGROUND

• Bhave NM, Freed BH, Yodwut C, Kolanczyk D, Dill K, Lang RM, Mor-Avi V, Patel AR. Considerations when measuring myocardial perfusion reserve by cardiovascular magnetic resonance using regadenoson. J Cardiovasc Magn Reson. 2012 Dec 28;14(1):89. doi: 10.1186/1532-429X-14-89.

  PMID: 23272658 DERIVED

MeSH Terms

Conditions

Coronary Disease

Interventions

regadenoson

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Limitations and Caveats

This study was conducted in a small number of healthy volunteers. We could not assess whether a rest stress protocol as opposed to a stress-recovery protocol would mask the presence of ischemia due to contrast contamination of stress images. It is possible that postregadenoson recovery imaging either earlier or later would have demonstrated a lesser degree of residual hyperemia. It is unknown whether a relatively modest underestimation of perfusion reserve would have clinical significance.

Results Point of Contact

• Title: Dr. Amit Patel
• Organization: The University of Chicago

apatel2@medicine.bsd.uchicago.edu

773-702-9461

Study Officials

• Amit Patel, M.D.

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2009
• First Posted: March 30, 2009
• Study Start: April 1, 2009
• Primary Completion: June 4, 2014
• Study Completion: June 4, 2014
• Last Updated: July 12, 2021
• Results First Posted: June 29, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)