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

Completed · Phase 3

Conditions studied: Arterial Occlusive Diseases, Coronary Disease, Heart Diseases, Myocardial Ischemia, Vascular Diseases, Arteriosclerosis, Ischemia, Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT00934037

Run by

Johns Hopkins University

People needed

444

Starts

2009-12-01

Expected to finish

2017-09-01

Last updated by the study team

2018-09-05

Who can join

Age: 45 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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, United States
• Albert Einstein Hospital — São Paulo, Brazil
• INCOR Heart Institute University-Sao Paulo — São Paulo, Brazil
• Toronto General Hospital — Toronto, Canada
• Rigshospitalet - University of Copenhagen — Blegdamsvej, Denmark
• Charite Humboldt University — Berlin, Germany
• Iwate Medical University — Morioka, Japan
• Keio University — Tokyo, Japan
• St. Luke's International Hospital — Tokyo, Japan
• Mie University — Tsu, Japan
• Leiden University — Leiden, Netherlands
• Mount Elizabeth Hospital — Singapore, Singapore
• National Heart Center — Singapore, Singapore

Full record on ClinicalTrials.gov

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