title: Multicenter Evaluation Of Coronary Dual-Source CT angiography in patients with intermediate Risk of Coronary Artery Stenoses (MEDIC): study design and rationale.
abstract: BACKGROUND
  The diagnostic performance of multidetector row CT to detect coronary artery stenosis has been evaluated in numerous single-center studies, with only limited data from large cohorts with low-to-intermediate likelihood of coronary disease and in multicenter trials. The Multicenter Evaluation of Coronary Dual-Source CT Angiography in Patients with Intermediate Risk of Coronary Artery Stenoses (MEDIC) trial determines the accuracy of dual-source CT (DSCT) to identify persons with at least 1 coronary artery stenosis among patients with low-to-intermediate pretest likelihood of disease.
  
  
  METHODS
  The MEDIC trial was designed as a prospective, multicenter, international trial to evaluate the diagnostic performance of DSCT for the detection of coronary artery stenosis compared with invasive coronary angiography. The study includes 8 sites in Germany, India, Mexico, the United States, and Denmark. The study population comprises patients referred for a diagnostic coronary angiogram because of suspected coronary artery disease with an intermediate pretest likelihood as determined by sex, age, and symptoms. All evaluations are performed by blinded core laboratory readers.
  
  
  RESULTS
  The primary outcome of the MEDIC trial is the accuracy of DSCT to identify the presence of coronary artery stenoses with a luminal diameter narrowing of 50% or more on a per-vessel basis. Secondary outcome parameters include per-patient and per-segment diagnostic accuracy for 50% stenoses and accuracy to identify stenoses of 70% or more. Furthermore, secondary outcome parameters include the influence of heart rate, Agatston score, body weight, body mass index, image quality, and diagnostic confidence on the accuracy to detect coronary artery stenoses >50% on a per-vessel basis.
  
  
  CONCLUSIONS
  The results of the MEDIC trial will assess the clinical utility of coronary CT angiography in the evaluation of patients with intermediate pretest likelihood of coronary artery disease.
authors.affiliation: Department of Cardiology, University of Erlangen, Ulmenweg 18, 91054 Erlangen, Germany. Electronic address: mohamed.marwan@uk-erlangen.de.
authors.forename: Mohamed
authors.initials: M
authors.lastname: Marwan
authors.affiliation: Department of Cardiology, Campus Grosshadern, University of Munich, Munich, Germany.
authors.forename: Jörg
authors.initials: J
authors.lastname: Hausleiter
authors.affiliation: Department of Radiology, University of Texas Southwestern Medical Center, Dallas, TX, USA.
authors.forename: Suhny
authors.initials: S
authors.lastname: Abbara
authors.affiliation: Department of Radiology, Massachusetts General Hospital, Boston, MA, USA.
authors.forename: Udo
authors.initials: U
authors.lastname: Hoffmann
authors.affiliation: Department of Radiology, Campus Grosshadern, University of Munich, Munich, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Becker
authors.affiliation: Department of Cardiology, Vejle Hospital, Denmark.
authors.forename: Kristian
authors.initials: K
authors.lastname: Ovrehus
authors.affiliation: Department of Cardiology, University of Erlangen, Ulmenweg 18, 91054 Erlangen, Germany.
authors.forename: Dieter
authors.initials: D
authors.lastname: Ropers
authors.affiliation: Depatment of Cardiology, CARE Hospital, Hyderabad, India.
authors.forename: Ravi
authors.initials: R
authors.lastname: Bathina
authors.affiliation: Cardiac Imaging and Nuclear Cardiology, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
authors.forename: Dan
authors.initials: D
authors.lastname: Berman
authors.affiliation: Department of Radiology, University of Erlangen, Erlangen, Germany.
authors.forename: Katharina
authors.initials: K
authors.lastname: Anders
authors.affiliation: Department of Radiology, University of Erlangen, Erlangen, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Uder
authors.affiliation: Facultad de Medicina, Universidad Nacional Autonoma de Mexico, Mexico City, Mexico; Cardiovascular Imaging and Nuclear Medicine Department, Instituto Nacional de Cardiologıa "Ignacio Chavez", Mexico City, Mexico.
authors.forename: Aloha
authors.initials: A
authors.lastname: Meave
authors.affiliation: Facultad de Medicina, Universidad Nacional Autonoma de Mexico, Mexico City, Mexico; Cardiovascular Imaging and Nuclear Medicine Department, Instituto Nacional de Cardiologıa "Ignacio Chavez", Mexico City, Mexico.
authors.forename: Erick
authors.initials: E
authors.lastname: Alexánderson
authors.affiliation: Department of Cardiology, University of Erlangen, Ulmenweg 18, 91054 Erlangen, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Achenbach
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000175:diagnosis*; D006801:Humans; D008875:Middle Aged; D012307:Risk Factors; D014057:Tomography, X-Ray Computed
keywords: CT; MEDIC; Multicenter