Combined Non-invasive Coronary Angiography and Myocardial Perfusion Imaging Using 320 Detector Computed Tomography (Core320)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Toshiba America Medical Systems, Inc.
Information provided by (Responsible Party):
Joao A.C Lima, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00934037
First received: May 11, 2009
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease
Procedure: 320 Volume Detector Computed Tomography
Other: Other: Multidetector Computed Tomography - 320 detectors
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Multi Center Combined Non-invasive Coronary Angiography and Myocardial Perfusion Imaging Using 320-Detector Computed Tomography

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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. [ Time Frame: 30-60 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 CAD. [ Time Frame: 30-60 Days ] [ Designated as safety issue: No ]
  • The combination of biomarkers and CT imaging obtained at baseline is superior to imaging or biomarkers alone in the i.d. of patients who will undergo subsequent coronary revascularization, and/or develop a major coronary event within 2 years. [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
  • Compare the relative diagnostic accuracy of 320 CT angiography vs SPECT in predicting at least one ≥ 50% coronary stenosis detected by QCA [ Time Frame: 30-60 Days ] [ Designated as safety issue: No ]
  • Compare the relative diagnostic accuracy of 320 CT perfusion vs SPECT in predicting at least one ≥ 50% coronary stenosis detected by quantitative conventional angiography. [ Time Frame: 30-60 Days ] [ Designated as safety issue: No ]

Enrollment: 444
Study Start Date: December 2009
Estimated Study Completion Date: September 2016
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Combined CT Angiography and Myocardial Perfusion
Single Arm study. All patients underwent combined CT Angiography and Myocardial Perfusion.
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
Other Name: Aquilion ONE CT scanner

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.

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00934037

Locations
United States, Maryland
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21205
National Heart Lung and Blood Institute (NHLBI)
Bethesda, Maryland, United States, 20892
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Brigham and Women Hospital
Boston, Massachusetts, United States, 02215
Brazil
INCOR Heart Institute University-Sao Paulo
Sao Paulo, Brazil
Albert Einstein Hospital
Sao Paulo, Brazil
Canada
Toronto General Hospital
Toronto, Canada
Denmark
Rigshospitalet - University of Copenhagen
Blegdamsvej, Denmark, 9, 2100
Germany
Charite Humboldt University
Berlin, Germany
Japan
Iwate Medical University
Morioka, Japan
St. Luke's International Hospital
Tokyo, Japan
Keio University
Tokyo, Japan
Mie University
TSU, Japan
Netherlands
Leiden University
Leiden, Netherlands
Singapore
National Heart Center
Singapore, Singapore
Mount Elizabeth Hospital
Singapore, Singapore
Sponsors and Collaborators
Johns Hopkins University
Toshiba America Medical Systems, Inc.
Investigators
Study Chair: Joao AC Lima, MD MBA Johns Hopkins School of Medicine
  More Information

Publications:

Responsible Party: Joao A.C Lima, Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00934037     History of Changes
Other Study ID Numbers: Core320
Study First Received: May 11, 2009
Last Updated: December 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Coronary Artery Disease
Computed Tomography
Myoperfusion
Angiography
SPECT

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Coronary Artery Disease
Coronary Disease
Heart Diseases
Ischemia
Myocardial Ischemia
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014