Standards for the function of an academic 12-lead electrocardiographic core laboratory.
An academic 12-lead electrocardiogram (ECG) core laboratory aims to provide the highest possible quality ECG recording, measurement, and storage to aid clinicians in research into important cardiovascular outcomes and to maximize the credibility of scientific results based solely, or in part, on ECG data. This position paper presents a guide for the structure and function of an academic ECG core laboratory. The key functional aspects are: 1) Data collection, 2) Staff composition, 3) Diagnostic measurement and definition standards, 4) Data management, 5) Academic considerations, 6) Economic consideration, and 7) Accreditation. An ECG Core Laboratory has the responsibility for rapid and accurate analysis and responsible management of the electrocardiographic data in multicenter clinical trials. Academic Laboratories, in addition, provide leadership in research protocol generation and production of research manuscripts for submission to the appropriate peer-review journals.
Anderson
S T
ST
Cabrini Hospital, Melbourne, Australia.
Pahlm
O
O
Bacharova
L
L
Barbagelata
A
A
Chaitman
B R
BR
Clemmensen
P
P
Goodman
S
S
Hedén
B
B
Klootwijk
P J
PJ
Lauer
M
M
MacFarlane
P W
PW
Rautaharju
P
P
Reddy
S
S
Selvester
R H
RH
Sgarbossa
E B
EB
Underwood
D
D
Warner
R A
RA
Wagner
G S
GS
D000068:Accreditation; D004562:Electrocardiography / Q000592:standards*; D006801:Humans; D007755:Laboratories, Hospital / Q000592:standards*; D012107:Research Design