Stress CT Perfusion in Patients With Chest Pain

NCT01969916 | Completed Results

• 1 other identifier: 15237B-AM005
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Our hypothesis is that quantitative 3D analysis of cardiac CT images obtained during vasodilator stress can accurately identify patients presenting at the emergency department with acute chest pain due to underlying hemodynamically significant coronary stenosis, aid in the identification of individuals most likely to benefit from revascularization, and thus improve the ability to predict patient outcomes. Our goals are:

1. 1.to test the above hypothesis by comparing stress MDCT perfusion data with invasive fractional flow reserve (FFR) data in patients with significant stenosis who undergo ICA;
2. 2.to determine the added value of MDCT perfusion as an adjunct to CTCA for predicting patient outcomes.

Conditions

Coronary Artery Disease

Keywords

Cardiac CT imaging; Myocardial ischemia; Myocardial perfusion; Vasodilator stress testing; Regadenoson

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Detected Stress-induced Perfusion Abnormalities by 3D Analysis of MDCT Images

  Perfusion defect on stress CT images obtained at peak effect of Regadenoson, in the presence of coronary stenosis \>50%.

  At least 1 year

Study Arms (1)

Regadenoson

OTHER

Drug: Regadenoson

Interventions

Regadenoson DRUG

Patients will be given a single dose of Lexiscan (0.4 mg, iv bolus)

Also known as: Lexiscan

Regadenoson

Eligibility Criteria

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

You may qualify if:

• patients with chest pain referred for CT coronary angiography

You may not qualify if:

• allergy to iodine,
• renal dysfunction (creatinine \>1.6 mg/dL)
• chronic obstructive pulmonary disease
• advanced heart block
• or systolic blood pressure \<90 mmHg

Sponsors & Collaborators

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

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Related Publications (12)

• Cerqueira MD, Weissman NJ, Dilsizian V, Jacobs AK, Kaul S, Laskey WK, Pennell DJ, Rumberger JA, Ryan T, Verani MS; American Heart Association Writing Group on Myocardial Segmentation and Registration for Cardiac Imaging. Standardized myocardial segmentation and nomenclature for tomographic imaging of the heart. A statement for healthcare professionals from the Cardiac Imaging Committee of the Council on Clinical Cardiology of the American Heart Association. Circulation. 2002 Jan 29;105(4):539-42. doi: 10.1161/hc0402.102975. No abstract available.

  PMID: 11815441 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

• de Roos A. Myocardial perfusion imaging with multidetector CT: beyond lumenography. Radiology. 2010 Feb;254(2):321-3. doi: 10.1148/radiol.09092106. No abstract available.

  PMID: 20093505 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

• Garcia MJ, Lessick J, Hoffmann MH; CATSCAN Study Investigators. Accuracy of 16-row multidetector computed tomography for the assessment of coronary artery stenosis. JAMA. 2006 Jul 26;296(4):403-11. doi: 10.1001/jama.296.4.403.

  PMID: 16868298 BACKGROUND

• Hulten EA, Bittencourt MS, Ghoshhajra B, Blankstein R. Stress CT perfusion: coupling coronary anatomy with physiology. J Nucl Cardiol. 2012 Jun;19(3):588-600. doi: 10.1007/s12350-012-9546-5.

  PMID: 22456969 BACKGROUND

• Kachenoura N, Veronesi F, Lodato JA, Corsi C, Mehta R, Newby B, Lang RM, Mor-Avi V. Volumetric quantification of myocardial perfusion using analysis of multi-detector computed tomography 3D datasets: comparison with nuclear perfusion imaging. Eur Radiol. 2010 Feb;20(2):337-47. doi: 10.1007/s00330-009-1552-x. Epub 2009 Aug 27.

  PMID: 19711083 BACKGROUND

• Miller JM, Rochitte CE, Dewey M, Arbab-Zadeh A, Niinuma H, Gottlieb I, Paul N, Clouse ME, Shapiro EP, Hoe J, Lardo AC, Bush DE, de Roos A, Cox C, Brinker J, Lima JA. Diagnostic performance of coronary angiography by 64-row CT. N Engl J Med. 2008 Nov 27;359(22):2324-36. doi: 10.1056/NEJMoa0806576.

  PMID: 19038879 BACKGROUND

• Mor-Avi V, Lodato JA, Kachenoura N, Chandra S, Freed BH, Newby B, Lang RM, Patel AR. Quantitative three-dimensional evaluation of myocardial perfusion during regadenoson stress using multidetector computed tomography. J Comput Assist Tomogr. 2012 Jul-Aug;36(4):443-9. doi: 10.1097/RCT.0b013e31825833a3.

  PMID: 22805675 BACKGROUND

• Patel AR, Lodato JA, Chandra S, Kachenoura N, Ahmad H, Freed BH, Newby B, Lang RM, Mor-Avi V. Detection of myocardial perfusion abnormalities using ultra-low radiation dose regadenoson stress multidetector computed tomography. J Cardiovasc Comput Tomogr. 2011 Jul-Aug;5(4):247-54. doi: 10.1016/j.jcct.2011.06.004. Epub 2011 Jun 12.

  PMID: 21723516 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

• Techasith T, Cury RC. Stress myocardial CT perfusion: an update and future perspective. JACC Cardiovasc Imaging. 2011 Aug;4(8):905-16. doi: 10.1016/j.jcmg.2011.04.017.

  PMID: 21835384 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia

Interventions

regadenoson

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Limitations and Caveats

The main limitation of quantitative analysis of myocardial perfusion from CT images is that it is prone to artifacts caused by beam hardening, which mimic perfusion defects.

Results Point of Contact

• Title: Victor Mor-Avi
• Organization: University of Chicago

vmoravi@bsd.uchicago.edu

773-702-7780

Study Officials

• Victor Mor-Avi, Ph.D.

  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: October 21, 2013
• First Posted: October 25, 2013
• Study Start: June 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: February 21, 2021
• Results First Posted: February 18, 2019

Record last verified: 2021-02

Locations

US (1)