TY - JOUR
T1 - Multicenter evaluation of coronary dual-source CT angiography in patients with intermediate risk of coronary artery stenoses (MEDIC)
T2 - Study design and rationale
AU - Marwan, Mohamed
AU - Hausleiter, Jörg
AU - Abbara, Suhny
AU - Hoffmann, Udo
AU - Becker, Christoph
AU - Ovrehus, Kristian
AU - Ropers, Dieter
AU - Bathina, Ravi
AU - Berman, Dan
AU - Anders, Katharina
AU - Uder, Michael
AU - Meave, Aloha
AU - Alexánderson, Erick
AU - Achenbach, Stephan
PY - 2014/5
Y1 - 2014/5
N2 - 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. Conclusion: 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.
AB - 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. Conclusion: 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.
KW - CT
KW - MEDIC
KW - Multicenter
UR - http://www.scopus.com/inward/record.url?scp=84902461479&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84902461479&partnerID=8YFLogxK
U2 - 10.1016/j.jcct.2014.04.006
DO - 10.1016/j.jcct.2014.04.006
M3 - Article
C2 - 24939066
AN - SCOPUS:84902461479
SN - 1934-5925
VL - 8
SP - 183
EP - 188
JO - Journal of cardiovascular computed tomography
JF - Journal of cardiovascular computed tomography
IS - 3
ER -