AzTrials
AzTrials

Arterial Occlusive DiseasesPhase 3Core320NCT00934037

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

A Phase 3 study testing 320 Volume Detector Computed Tomography and Other: Multidetector Computed Tomography - 320 detectors in people with Arterial Occlusive Diseases and Coronary Disease, run by Johns Hopkins University at 16 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 45 to 85 years
What is being tested?
320 Volume Detector Computed Tomography and Other: Multidetector Computed Tomography - 320 detectors
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
444 participants
Where
16 sitesin 8 countries
Study dates
Dec 2009to Sep 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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

Trial locations and contacts

16 sites in 8 countries.

16 sites in 8 countries

United States4 sites

  • Johns Hopkins School of Medicine

    Baltimore, Maryland, 21205

  • National Heart Lung and Blood Institute (NHLBI)

    Bethesda, Maryland, 20892

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Brigham and Women Hospital

    Boston, Massachusetts, 02215

Other trials in United States

Japan4 sites

  • Iwate Medical University

    Morioka

  • Keio University

    Tokyo

  • St. Luke's International Hospital

    Tokyo

  • Mie University

    Tsu

Other trials in Japan

Brazil2 sites

  • Albert Einstein Hospital

    São Paulo

  • INCOR Heart Institute University-Sao Paulo

    São Paulo

Other trials in Brazil

Singapore2 sites

  • Mount Elizabeth Hospital

    Singapore

  • National Heart Center

    Singapore

Other trials in Singapore

Canada1 site

  • Toronto General Hospital

    Toronto

Other trials in Canada

Denmark1 site

  • Rigshospitalet - University of Copenhagen

    Blegdamsvej, 9, 2100

Other trials in Denmark

Germany1 site

  • Charite Humboldt University

    Berlin

Other trials in Germany

Netherlands1 site

  • Leiden University

    Leiden

Other trials in Netherlands

About this study

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

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.

Read the detailed 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.

Being tested
320 Volume Detector Computed Tomography, Other: Multidetector Computed Tomography - 320 detectors
Keywords
Coronary Artery Disease, Computed Tomography, Myoperfusion, Angiography, SPECT
Medical subject headings
Arterial Occlusive Diseases, Coronary Disease, Heart Diseases, Myocardial Ischemia, Vascular Diseases, Arteriosclerosis, Ischemia, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 320 Volume Detector Computed TomographyProcedure or surgery

    Single Arm Study. All patients undergo Volume (Multidetector) CT.

  • Other: Multidetector Computed Tomography - 320 detectorsOther

    Also called Aquilion ONE CT scanner

    Multidetector computed tomography angiography

Study groups in NCT00934037
Study groupRoleWhat they receive
Combined CT Angiography and Myocardial PerfusionOtherSingle Arm study. All patients underwent combined CT Angiography and Myocardial Perfusion.
Receives: Procedure: 320 Volume Detector Computed Tomography; Other: Other: Multidetector Computed Tomography - 320 detectors

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 30-60 Days

Secondary outcomes (3)

  1. 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.

    Measured: 30-60 Days

  2. 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

    Measured: 30-60 Days

  3. 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.

    Measured: 30-60 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionSep 2011
  4. Study completionSep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
444 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00934037
Sponsor's protocol ID
NA_00022661
Other IDs
Core320
Acronym
Core320
Status last verified
Aug 2018
First submitted
11 May 2009
Last updated
5 Sep 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19038879

  • 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.

    PubMed 22146496

  • 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.

    PubMed 18998142

  • 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.

    PubMed 23185678

  • 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. doi: 10.1161/CIRCIMAGING.111.970608. Epub 2012 Aug 10.

    PubMed 22887690

  • 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.

    PubMed 22447807

  • 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.

    PubMed 21940569

  • 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.

    PubMed 22146495

  • Li Z, Tu S, Matheson MB, Li G, Chen Y, Rochitte CE, Chen MY, Dewey M, Miller JM, R Scarpa Matuck B, Yang W, Qin L, Yan F, Lima JAC, Arbab-Zadeh A. Prognostic Value of Coronary CT Angiography-Derived Quantitative Flow Ratio in Suspected Coronary Artery Disease. Radiology. 2024 Dec;313(3):e240299. doi: 10.1148/radiol.240299.

    PubMed 39656122

  • Preuss D, Garcia G, Laule M, Dewey M, Rief M. Myocardial CT perfusion imaging for the detection of obstructive coronary artery disease: multisegment reconstruction does not improve diagnostic performance. Eur Radiol Exp. 2022 Jan 31;6(1):5. doi: 10.1186/s41747-021-00256-8.

    PubMed 35099638

  • Dewey M, Rochitte CE, Ostovaneh MR, Chen MY, George RT, Niinuma H, Kitagawa K, Laham R, Kofoed K, Nomura C, Sakuma H, Yoshioka K, Mehra VC, Jinzaki M, Kuribayashi S, Laule M, Paul N, Scholte AJ, Cerci R, Hoe J, Tan SY, Rybicki FJ, Matheson MB, Vavere AL, Arai AE, Miller JM, Cox C, Brinker J, Clouse ME, Di Carli M, Lima JAC, Arbab-Zadeh A. Prognostic value of noninvasive combined anatomic/functional assessment by cardiac CT in patients with suspected coronary artery disease - Comparison with invasive coronary angiography and nuclear myocardial perfusion imaging for the five-year-follow up of the CORE320 multicenter study. J Cardiovasc Comput Tomogr. 2021 Nov-Dec;15(6):485-491. doi: 10.1016/j.jcct.2021.04.005. Epub 2021 May 12.

    PubMed 34024757

  • Kishi S, Magalhaes TA, Cerci RJ, Zimmermann E, Matheson MB, Vavere A, Tanami Y, Kitslaar PH, George RT, Brinker J, Miller JM, Clouse ME, Lemos PA, Niinuma H, Reiber JHC, Kofoed KF, Rochitte CE, Rybicki FJ, Di Carli MF, Cox C, Lima JAC, Arbab-Zadeh A. Comparative effectiveness of coronary artery stenosis and atherosclerotic plaque burden assessment for predicting 30-day revascularization and 2-year major adverse cardiac events. Int J Cardiovasc Imaging. 2020 Dec;36(12):2365-2375. doi: 10.1007/s10554-020-01851-3. Epub 2020 May 2.

    PubMed 32361925

  • Schuijf JD, Matheson MB, Ostovaneh MR, Arbab-Zadeh A, Kofoed KF, Scholte AJHA, Dewey M, Steveson C, Rochitte CE, Yoshioka K, Cox C, Di Carli MF, Lima JAC. Ischemia and No Obstructive Stenosis (INOCA) at CT Angiography, CT Myocardial Perfusion, Invasive Coronary Angiography, and SPECT: The CORE320 Study. Radiology. 2020 Jan;294(1):61-73. doi: 10.1148/radiol.2019190978. Epub 2019 Nov 19.

    PubMed 31746688

  • Song YB, Arbab-Zadeh A, Matheson MB, Ostovaneh MR, Vavere AL, Dewey M, Rochitte C, Niinuma H, Laham R, Schuijf JD, Cox C, Brinker J, di Carli M, Lima JAC, Miller JM. Contemporary Discrepancies of Stenosis Assessment by Computed Tomography and Invasive Coronary Angiography. Circ Cardiovasc Imaging. 2019 Feb;12(2):e007720. doi: 10.1161/CIRCIMAGING.118.007720.

    PubMed 30764641

  • Rief M, Chen MY, Vavere AL, Kendziora B, Miller JM, Bandettini WP, Cox C, George RT, Lima J, Di Carli M, Plotkin M, Zimmermann E, Laule M, Schlattmann P, Arai AE, Dewey M. Coronary Artery Disease: Analysis of Diagnostic Performance of CT Perfusion and MR Perfusion Imaging in Comparison with Quantitative Coronary Angiography and SPECT-Multicenter Prospective Trial. Radiology. 2018 Feb;286(2):461-470. doi: 10.1148/radiol.2017162447. Epub 2017 Sep 25.

    PubMed 28956734

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 320 Volume Detector Computed Tomography and Other: Multidetector Computed Tomography - 320 detectors in people with Arterial Occlusive Diseases and Coronary Disease, run by Johns Hopkins University at 16 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States, Japan, Brazil, Singapore, Canada and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic accuracy of volume (multi-detector) computed tomography using 320 detectors in a patient with suspected coronary artery disease. (time frame: 30-60 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00934037, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in