Multivariable Assessment of Coronary Artery Disease Using Cardiac CT Imaging - Full Text View

Sponsors and Collaborators:	University of Chicago Astellas Pharma Inc
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00857792

Purpose

The investigators goals are:

to develop software for quantitative volumetric analysis of myocardial perfusion from MDCT images
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
to test this approach in patients undergoing vasodilator stress tests with MDCT imaging in combination with the new vasodilator stress agent Regadenoson.

Condition	Intervention
Coronary Disease	Drug: regadenoson

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Multivariable Assessment of Coronary Artery Disease Using Cardiac CT Imaging

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: CVT 3146

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:

Differences in regional myocardial perfusion measured from MDCT images confirmed by coronary angiography and/or SPECT. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	March 2009
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Open Label	Drug: regadenoson Subjects will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus).

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857792

Contacts

Contact: Victor Mor-Avi, PhD	773-702-7780	vmoravi@medicine.bsd.uchicago.edu
Contact: Joseph Lodato, MD	773-834-1556	jlodato@medicine.bsd.uchicago.edu

Locations

United States, Illinois
University of Chicago	Recruiting
Chicago, Illinois, United States, 60637
Contact: Victor Mor-Avi, PhD 773-702-7780 vmoravi@medicine.bsd.uchicago.edu
Contact: Joseph Lodato, MD 773-834-1556 jlodato@medicine.bsd.uchicago.edu
Principal Investigator: Victor Mor-Avi, PhD
Sub-Investigator: Roberto Lang, MD
Sub-Investigator: Joseph Lodato, MD
Sub-Investigator: Nadjia Kachenoura, PhD

Sponsors and Collaborators

University of Chicago

Astellas Pharma Inc

Investigators

Principal Investigator:

Victor Mor-Avi, PhD

University of Chicago

More Information

Publications:

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. Review.

Deetjen AG, Conradi G, Möllmann S, Ekinci O, Weber M, Nef H, Möllmann 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.

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. Epub 2007 Dec 15. Review.

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.

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.

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.

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. Epub 2007 Mar 19.

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. Epub 2006 Nov 28.

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.

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. Review.

Mahnken AH, Koos R, Katoh M, Wildberger JE, Spuentrup E, Buecker A, Günther RW, Kühl 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.

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. Epub 2005 Mar 18.

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. Epub 2006 Feb 6.

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. Epub 2006 Jun 1.

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. Epub 2006 Jun 6.

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. Epub 2004 Apr 29.

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.

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.

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.

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. Epub 2005 Aug 15.

Responsible Party:	University of Chicago ( Victor Mor-Avi, PhD )
Study ID Numbers:	15237B
Study First Received:	March 5, 2009
Last Updated:	March 5, 2009
ClinicalTrials.gov Identifier:	NCT00857792 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Chicago:

Coronary Disease
Cardiac CT Imaging
Stress Testing
Lexiscan (regadenoson)

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Stress
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on September 10, 2009