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

Phase 3

Completed

• Conditions: Coronary Artery Disease; Vascular Diseases; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Myocardial Ischemia; Arteriosclerosis; Ischemia
• Interventions: Procedure: 320 Volume Detector Computed Tomography

• Registration Number: NCT00934037
• Lead Sponsor: Johns Hopkins University

Brief 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.

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.

Study Timeline

• Study First Submitted: 2009-05-11
• Study First Submitted QC: 2009-07-07
• Study First Posted: 2009-07-08
• Study Start: 2009-12
• Primary Completion: 2011-09
• Study Completion: 2017-09
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-31
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 444

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Combined CT Angiography and Myocardial Perfusion	320 Volume Detector Computed Tomography	Single Arm study. All patients underwent combined CT Angiography and Myocardial Perfusion.

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of volume (multi-detector) computed tomography using 320 detectors in a patient with suspected coronary artery disease.	30-60 Days	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.

Secondary Outcome Measures

Name	Time	Method
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	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 angiography vs SPECT in predicting at least one ≥ 50% coronary stenosis detected by QCA	30-60 Days	Compare the relative diagnostic accuracy of 320 CT angiography vs SPECT in predicting at least one ≥ 50% coronary stenosis detected by QCA
Diagnostic accuracy of volume computed tomography using 320 detectors in a vessel of a patient with suspected coronary artery disease.	30-60 Days	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.

Trial Locations

Locations (16)

Mount Elizabeth Hospital; 🇸🇬 Singapore, Singapore

St. Luke's International Hospital; 🇯🇵 Tokyo, Japan

Toronto General Hospital; 🇨🇦 Toronto, Canada

Mie University; 🇯🇵 TSU, Japan

Brigham and Women Hospital; 🇺🇸 Boston, Massachusetts, United States

Albert Einstein Hospital; 🇧🇷 Sao Paulo, Brazil

Rigshospitalet - University of Copenhagen; 🇩🇰 Blegdamsvej, Denmark

Keio University; 🇯🇵 Tokyo, Japan

Johns Hopkins School of Medicine; 🇺🇸 Baltimore, Maryland, United States

Charite Humboldt University; 🇩🇪 Berlin, Germany

National Heart Center; 🇸🇬 Singapore, Singapore

INCOR Heart Institute University-Sao Paulo; 🇧🇷 Sao Paulo, Brazil

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

National Heart Lung and Blood Institute (NHLBI); 🇺🇸 Bethesda, Maryland, United States

Iwate Medical University; 🇯🇵 Morioka, Japan

Leiden University; 🇳🇱 Leiden, Netherlands