Combined Non-invasive Coronary Angiography and Myocardial Perfusion Imaging Using 320 Detector Computed Tomography

Coronary Artery Disease Clinical Trial

— Core320  

Official title:

Multi Center Combined Non-invasive Coronary Angiography and Myocardial Perfusion Imaging Using 320-Detector Computed Tomography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00934037
• Other study ID #: NA_00022661
• Secondary ID: Core320
• Status: Completed
• Phase: Phase 3
• Start date: December 2009
• Est. completion date: September 2017

Study information

• Verified date: August 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the diagnostic accuracy of multi-detector computed tomography using 320 detectors for identifying the combination of coronary artery stenosis ≥ 50% and a corresponding myocardium perfusion defect in a patient with suspected coronary artery disease compared with conventional coronary angiography and single photon emission computed tomography myocardium perfusion imaging.

Description:

The Combined Coronary angiography and myocardial perfusion imaging using 320 detectors computed tomography (CORE-320) was designed as a prospective, multi-center, international, blinded study designed to evaluate the diagnostic accuracy of multi-detector computed tomography using 320 detectors for identifying coronary artery luminal stenosis and corresponding myocardium perfusion defects in patients with suspected coronary artery disease. The primary analysis will be a comparison of the diagnostic capability of the combination of quantitative 320-MDCT angiography and quantitative perfusion imaging to the combination of conventional coronary angiography and SPECT myocardial perfusion imaging at the patient level. A positive patient will be defined as having at least one vessel with a ≥ 50% diameter stenosis defined by quantitative coronary angiography and a corresponding positive SPECT territorial myocardial perfusion defect.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 444
• Est. completion date: September 2017
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

Inclusion Criteria:

• Male or female patients, age 45-85. Women of child bearing potential must demonstrate a negative pregnancy test within 24 hours of the study MDCT.

• Suspected or diagnosed coronary artery disease with a clinical indication for coronary angiography; and planned coronary angiography within the next 60 days.

• Able to understand and willing to sign the Informed Consent Form.

Exclusion Criteria:

• Known allergy to iodinated contrast media.

• History of contrast-induced nephropathy.

• History of multiple myeloma or previous organ transplantation.

• Elevated serum creatinine (> 1.5 mg/dl) OR calculated creatinine clearance of < 60 ml/min (using the Cockcroft-Gault formula.

• Atrial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block (second or third degree heart block).

• Evidence of severe symptomatic heart failure (NYHA Class III or IV); Known or suspected moderate or severe aortic stenosis.

• Previous coronary artery bypass or other cardiac surgery.

• Coronary artery intervention within the last 6 months.

• Known or suspected intolerance or contraindication to beta-blockers including:

• Known allergy to beta-blockers

• History of moderate to severe bronchospastic lung disease (including moderate to severe asthma).

• Severe pulmonary disease (chronic obstructive pulmonary disease).

• Presence of any other history or condition that the investigator feels would be problematic.

• SPECT preformed in non-validated center within 60 days prior to screening.

• SPECT performed within the previous 6 months of screening but > 60 days.

• SPECT studies performed within 60 days of screening that include rest and stress studies performed using 2 day protocols.

• BMI greater than 40

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Arteriosclerosis
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Ischemia
• Myocardial Ischemia
• Vascular Diseases

Intervention

Procedure:
• 320 Volume Detector Computed Tomography
Single Arm Study. All patients undergo Volume (Multidetector) CT.

Other:
• Other: Multidetector Computed Tomography - 320 detectors
Multidetector computed tomography angiography

Locations

Country	Name	City	State
Brazil	Albert Einstein Hospital	Sao Paulo
Brazil	INCOR Heart Institute University-Sao Paulo	Sao Paulo
Canada	Toronto General Hospital	Toronto
Denmark	Rigshospitalet - University of Copenhagen	Blegdamsvej
Germany	Charite Humboldt University	Berlin
Japan	Iwate Medical University	Morioka
Japan	Keio University	Tokyo
Japan	St. Luke's International Hospital	Tokyo
Japan	Mie University	TSU
Netherlands	Leiden University	Leiden
Singapore	Mount Elizabeth Hospital	Singapore
Singapore	National Heart Center	Singapore
United States	Johns Hopkins School of Medicine	Baltimore	Maryland
United States	National Heart Lung and Blood Institute (NHLBI)	Bethesda	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Toshiba America Medical Systems, Inc.

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  Denmark,  Germany,  Japan,  Netherlands,  Singapore, 

References & Publications (8)

Cerci RJ, Arbab-Zadeh A, George RT, Miller JM, Vavere AL, Mehra V, Yoneyama K, Texter J, Foster C, Guo W, Cox C, Brinker J, Di Carli M, Lima JA. Aligning coronary anatomy and myocardial perfusion territories: an algorithm for the CORE320 multicenter study. Circ Cardiovasc Imaging. 2012 Sep 1;5(5):587-95. Epub 2012 Aug 10. — View Citation

George RT, Arbab-Zadeh A, Cerci RJ, Vavere AL, Kitagawa K, Dewey M, Rochitte CE, Arai AE, Paul N, Rybicki FJ, Lardo AC, Clouse ME, Lima JA. Diagnostic performance of combined noninvasive coronary angiography and myocardial perfusion imaging using 320-MDCT: the CT angiography and perfusion methods of the CORE320 multicenter multinational diagnostic study. AJR Am J Roentgenol. 2011 Oct;197(4):829-37. doi: 10.2214/AJR.10.5689. — View Citation

George RT, Arbab-Zadeh A, Miller JM, Vavere AL, Bengel FM, Lardo AC, Lima JA. Computed tomography myocardial perfusion imaging with 320-row detector computed tomography accurately detects myocardial ischemia in patients with obstructive coronary artery disease. Circ Cardiovasc Imaging. 2012 May 1;5(3):333-40. doi: 10.1161/CIRCIMAGING.111.969303. Epub 2012 Mar 23. — View Citation

Mehra VC, Valdiviezo C, Arbab-Zadeh A, Ko BS, Seneviratne SK, Cerci R, Lima JA, George RT. A stepwise approach to the visual interpretation of CT-based myocardial perfusion. J Cardiovasc Comput Tomogr. 2011 Nov-Dec;5(6):357-69. doi: 10.1016/j.jcct.2011.10.010. Epub 2011 Oct 31. Review. — View Citation

Miller JM, Dewey M, Vavere AL, Rochitte CE, Niinuma H, Arbab-Zadeh A, Paul N, Hoe J, de Roos A, Yoshioka K, Lemos PA, Bush DE, Lardo AC, Texter J, Brinker J, Cox C, Clouse ME, Lima JA. Coronary CT angiography using 64 detector rows: methods and design of the multi-centre trial CORE-64. Eur Radiol. 2009 Apr;19(4):816-28. doi: 10.1007/s00330-008-1203-7. Epub 2008 Nov 8. — View Citation

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. — View Citation

Vavere AL, Simon GG, George RT, Rochitte CE, Arai AE, Miller JM, Di Carli M, Arbab-Zadeh A, Dewey M, Niinuma H, Laham R, Rybicki FJ, Schuijf JD, Paul N, Hoe J, Kuribyashi S, Sakuma H, Nomura C, Yaw TS, Kofoed KF, Yoshioka K, Clouse ME, Brinker J, Cox C, Lima JA. Diagnostic performance of combined noninvasive coronary angiography and myocardial perfusion imaging using 320 row detector computed tomography: design and implementation of the CORE320 multicenter, multinational diagnostic study. J Cardiovasc Comput Tomogr. 2011 Nov-Dec;5(6):370-81. doi: 10.1016/j.jcct.2011.11.001. Epub 2011 Nov 12. Erratum in: J Cardiovasc Comput Tomogr. 2012 Mar-Apr;6(2):146. Zadeh, Armin A [corrected to Arbab-Zadeh, Armin]. — View Citation

Yoneyama K, Vavere AL, Cerci R, Ahmed R, Arai AE, Niinuma H, Rybicki FJ, Rochitte CE, Clouse ME, George RT, Lima JA, Arbab-Zadeh A. Influence of image acquisition settings on radiation dose and image quality in coronary angiography by 320-detector volume computed tomography: the CORE320 pilot experience. Heart Int. 2012 Jun 5;7(2):e11. doi: 10.4081/hi.2012.e11. Epub 2012 Jun 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of volume (multi-detector) computed tomography using 320 detectors in a patient with suspected coronary artery disease.	Diagnostic accuracy of volume (multi-detector) computed tomography using 320 detectors for identifying coronary artery luminal stenosis and corresponding myocardium perfusion defects in a patient with suspected coronary artery disease.	30-60 Days
Secondary	Diagnostic accuracy of volume computed tomography using 320 detectors in a vessel of a patient with suspected coronary artery disease.	Diagnostic accuracy of volume computed tomography using 320 detectors for identifying coronary artery luminal stenosis and corresponding territorial myocardium perfusion defects in a vessel of a patient with suspected coronary artery disease.	30-60 Days
Secondary	Compare the relative diagnostic accuracy of 320 CT angiography vs SPECT in predicting at least one = 50% coronary stenosis detected by QCA	Compare the relative diagnostic accuracy of 320 CT angiography vs SPECT in predicting at least one = 50% coronary stenosis detected by QCA	30-60 Days
Secondary	Compare the relative diagnostic accuracy of 320 CT perfusion vs SPECT in predicting at least one = 50% coronary stenosis detected by quantitative conventional angiography.	Compare the relative diagnostic accuracy of 320 CT perfusion vs SPECT in predicting at least one = 50% coronary stenosis detected by quantitative conventional angiography.	30-60 Days