Multivariable Assessment of Coronary Artery Disease Using Cardiac CT Imaging

NCT00857792 | Completed Results

• 1 other identifier: 15237B
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators goals are:

1. 1.to develop software for quantitative volumetric analysis of myocardial perfusion from MDCT images
2. 2.to test its ability to accurately determine the presence, location, extend and severity of perfusion abnormalities in agreement with conventional diagnostic techniques (ICA and MPI) in patients with normal and abnormal coronary arteries and/or perfusion patterns
3. 3.to test this approach in patients undergoing vasodilator stress tests with MDCT imaging in combination with the new vasodilator stress agent Regadenoson.

Conditions

Coronary Disease

Keywords

Coronary Disease; Cardiac CT Imaging; Stress Testing; Lexiscan (regadenoson)

Outcome Measures

Primary Outcomes (1)

• Ability to Detect Stress-induced Myocardial Perfusion Abnormalities by Analysis of MDCT Images Confirmed by Coronary Angiography and/or SPECT.

  3 months

Study Arms (1)

Open Label

OTHER

Drug: regadenoson

Interventions

regadenoson DRUG

Subjects will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus).

Also known as: Lexiscan

Open Label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• Subjects referred for clinically indicated cardiac CT exams

You may not qualify if:

• Subjects with a history of lung disease
• Pregnant subjects
• Subjects with second or third degree AV block or sinus node dysfunction

Sponsors & Collaborators

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

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (20)

• de Roos A, Kroft LJ, Bax JJ, Geleijns J. Applications of multislice computed tomography in coronary artery disease. J Magn Reson Imaging. 2007 Jul;26(1):14-22. doi: 10.1002/jmri.20971.

  PMID: 17659542 BACKGROUND

• Deetjen AG, Conradi G, Mollmann S, Ekinci O, Weber M, Nef H, Mollmann H, Hamm CW, Dill T. Diagnostic value of the 16-detector row multislice spiral computed tomography for the detection of coronary artery stenosis in comparison to invasive coronary angiography. Clin Cardiol. 2007 Mar;30(3):118-23. doi: 10.1002/clc.20059.

  PMID: 17385719 BACKGROUND

• Schroeder S, Achenbach S, Bengel F, Burgstahler C, Cademartiri F, de Feyter P, George R, Kaufmann P, Kopp AF, Knuuti J, Ropers D, Schuijf J, Tops LF, Bax JJ; Working Group Nuclear Cardiology and Cardiac CT; European Society of Cardiology; European Council of Nuclear Cardiology. Cardiac computed tomography: indications, applications, limitations, and training requirements: report of a Writing Group deployed by the Working Group Nuclear Cardiology and Cardiac CT of the European Society of Cardiology and the European Council of Nuclear Cardiology. Eur Heart J. 2008 Feb;29(4):531-56. doi: 10.1093/eurheartj/ehm544. Epub 2007 Dec 15.

  PMID: 18084017 BACKGROUND

• Leber AW, Knez A, von Ziegler F, Becker A, Nikolaou K, Paul S, Wintersperger B, Reiser M, Becker CR, Steinbeck G, Boekstegers P. Quantification of obstructive and nonobstructive coronary lesions by 64-slice computed tomography: a comparative study with quantitative coronary angiography and intravascular ultrasound. J Am Coll Cardiol. 2005 Jul 5;46(1):147-54. doi: 10.1016/j.jacc.2005.03.071.

  PMID: 15992649 BACKGROUND

• Raff GL, Gallagher MJ, O'Neill WW, Goldstein JA. Diagnostic accuracy of noninvasive coronary angiography using 64-slice spiral computed tomography. J Am Coll Cardiol. 2005 Aug 2;46(3):552-7. doi: 10.1016/j.jacc.2005.05.056.

  PMID: 16053973 BACKGROUND

• Budoff MJ, Rasouli ML, Shavelle DM, Gopal A, Gul KM, Mao SS, Liu SH, McKay CR. Cardiac CT angiography (CTA) and nuclear myocardial perfusion imaging (MPI)-a comparison in detecting significant coronary artery disease. Acad Radiol. 2007 Mar;14(3):252-7. doi: 10.1016/j.acra.2006.11.006.

  PMID: 17307657 BACKGROUND

• Rubinshtein R, Halon DA, Gaspar T, Jaffe R, Karkabi B, Flugelman MY, Kogan A, Shapira R, Peled N, Lewis BS. Usefulness of 64-slice cardiac computed tomographic angiography for diagnosing acute coronary syndromes and predicting clinical outcome in emergency department patients with chest pain of uncertain origin. Circulation. 2007 Apr 3;115(13):1762-8. doi: 10.1161/CIRCULATIONAHA.106.618389. Epub 2007 Mar 19.

  PMID: 17372178 BACKGROUND

• Schuijf JD, Wijns W, Jukema JW, Atsma DE, de Roos A, Lamb HJ, Stokkel MP, Dibbets-Schneider P, Decramer I, De Bondt P, van der Wall EE, Vanhoenacker PK, Bax JJ. Relationship between noninvasive coronary angiography with multi-slice computed tomography and myocardial perfusion imaging. J Am Coll Cardiol. 2006 Dec 19;48(12):2508-14. doi: 10.1016/j.jacc.2006.05.080. Epub 2006 Nov 28.

  PMID: 17174190 BACKGROUND

• Hacker M, Jakobs T, Matthiesen F, Nikolaou K, Becker C, Knez A, Tiling R. Combined functional and morphological imaging consisting of gated myocardial perfusion SPECT and 16-detector multislice spiral CT angiography in the noninvasive evaluation of coronary artery disease: first experiences. Clin Imaging. 2007 Sep-Oct;31(5):313-20. doi: 10.1016/j.clinimag.2007.03.013.

  PMID: 17825738 BACKGROUND

• Cury RC, Nieman K, Shapiro MD, Nasir K, Cury RC, Brady TJ. Comprehensive cardiac CT study: evaluation of coronary arteries, left ventricular function, and myocardial perfusion--is it possible? J Nucl Cardiol. 2007 Apr;14(2):229-43. doi: 10.1016/j.nuclcard.2007.01.035.

  PMID: 17386386 BACKGROUND

• Mahnken AH, Koos R, Katoh M, Wildberger JE, Spuentrup E, Buecker A, Gunther RW, Kuhl HP. Assessment of myocardial viability in reperfused acute myocardial infarction using 16-slice computed tomography in comparison to magnetic resonance imaging. J Am Coll Cardiol. 2005 Jun 21;45(12):2042-7. doi: 10.1016/j.jacc.2005.03.035.

  PMID: 15963407 BACKGROUND

• Nikolaou K, Sanz J, Poon M, Wintersperger BJ, Ohnesorge B, Rius T, Fayad ZA, Reiser MF, Becker CR. Assessment of myocardial perfusion and viability from routine contrast-enhanced 16-detector-row computed tomography of the heart: preliminary results. Eur Radiol. 2005 May;15(5):864-71. doi: 10.1007/s00330-005-2672-6. Epub 2005 Mar 18.

  PMID: 15776243 BACKGROUND

• Gerber BL, Belge B, Legros GJ, Lim P, Poncelet A, Pasquet A, Gisellu G, Coche E, Vanoverschelde JL. Characterization of acute and chronic myocardial infarcts by multidetector computed tomography: comparison with contrast-enhanced magnetic resonance. Circulation. 2006 Feb 14;113(6):823-33. doi: 10.1161/CIRCULATIONAHA.104.529511. Epub 2006 Feb 6.

  PMID: 16461822 BACKGROUND

• Henneman MM, Schuijf JD, Jukema JW, Lamb HJ, de Roos A, Dibbets P, Stokkel MP, van der Wall EE, Bax JJ. Comprehensive cardiac assessment with multislice computed tomography: evaluation of left ventricular function and perfusion in addition to coronary anatomy in patients with previous myocardial infarction. Heart. 2006 Dec;92(12):1779-83. doi: 10.1136/hrt.2006.087874. Epub 2006 Jun 1.

  PMID: 16740917 BACKGROUND

• Nieman K, Cury RC, Ferencik M, Nomura CH, Abbara S, Hoffmann U, Gold HK, Jang IK, Brady TJ. Differentiation of recent and chronic myocardial infarction by cardiac computed tomography. Am J Cardiol. 2006 Aug 1;98(3):303-8. doi: 10.1016/j.amjcard.2006.01.101. Epub 2006 Jun 6.

  PMID: 16860013 BACKGROUND

• Hoffmann U, Millea R, Enzweiler C, Ferencik M, Gulick S, Titus J, Achenbach S, Kwait D, Sosnovik D, Brady TJ. Acute myocardial infarction: contrast-enhanced multi-detector row CT in a porcine model. Radiology. 2004 Jun;231(3):697-701. doi: 10.1148/radiol.2313030132. Epub 2004 Apr 29.

  PMID: 15118118 BACKGROUND

• Lardo AC, Cordeiro MA, Silva C, Amado LC, George RT, Saliaris AP, Schuleri KH, Fernandes VR, Zviman M, Nazarian S, Halperin HR, Wu KC, Hare JM, Lima JA. Contrast-enhanced multidetector computed tomography viability imaging after myocardial infarction: characterization of myocyte death, microvascular obstruction, and chronic scar. Circulation. 2006 Jan 24;113(3):394-404. doi: 10.1161/CIRCULATIONAHA.105.521450.

  PMID: 16432071 BACKGROUND

• George RT, Jerosch-Herold M, Silva C, Kitagawa K, Bluemke DA, Lima JA, Lardo AC. Quantification of myocardial perfusion using dynamic 64-detector computed tomography. Invest Radiol. 2007 Dec;42(12):815-22. doi: 10.1097/RLI.0b013e318124a884.

  PMID: 18007153 BACKGROUND

• Limbruno U, Petronio AS, Amoroso G, Baglini R, Paterni G, Merelli A, Mariotti R, Raffaele De Caterina, Mariani M. The impact of coronary artery disease on the coronary vasomotor response to nonionic contrast media. Circulation. 2000 Feb 8;101(5):491-7. doi: 10.1161/01.cir.101.5.491.

  PMID: 10662745 BACKGROUND

• Corsi C, Lang RM, Veronesi F, Weinert L, Caiani EG, MacEneaney P, Lamberti C, Mor-Avi V. Volumetric quantification of global and regional left ventricular function from real-time three-dimensional echocardiographic images. Circulation. 2005 Aug 23;112(8):1161-70. doi: 10.1161/CIRCULATIONAHA.104.513689. Epub 2005 Aug 15.

  PMID: 16103242 BACKGROUND

MeSH Terms

Conditions

Coronary Disease

Interventions

regadenoson

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Results Point of Contact

• Title: Victor Mor-Avi
• Organization: The University of Chicago Medical Center

vmoravi@bsd.uchicago.edu

773-702-7780

Study Officials

• Victor Mor-Avi, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2009
• First Posted: March 9, 2009
• Study Start: March 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: May 11, 2016
• Results First Posted: December 2, 2014

Record last verified: 2016-05

Locations

US (1)