This data set, its source, and the methods used to generate it, are described in
The data set is also used in
ClinicalTrials.gov identifier: NCT01873950
When referencing this material, please include at least one of the citations above, and also include the standard citation for PhysioNet:
The ECGRDVQ database contains multi-channel ECG recordings of 22 healthy subjects partaking in a randomized, double‐blind, 5‐period crossover clinical trial aimed at comparing the effects of four known QT prolonging drugs versus placebo on electrophysiological and other clinical parameters.
In the morning of each period of the five 24-hour periods, each subject received a single dose of 500 μg dofetilide (Tikosyn, Pfizer, New York, NY), 400 mg quinidine sulfate (Watson Pharma, Corona, CA), 1500 mg ranolazine (Ranexa, Gilead, Foster City, CA), 120 mg verapamil hydrochloride (Heritage Pharmaceuticals, Edison, NJ) or placebo under fasting conditions. There was a 7-day washout period between each 24‐hour treatment period.
During each period, continuous ECGs were recorded at 500 Hz with an amplitude resolution of 2.5 μV. From the continuous recording, triplicate 10‐second ECGs were extracted at 16 predefined time-points: 1 point pre-dose (-0.5 h) and 15 points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 14, and 24 h), during which the subjects were resting in a supine position for 10 minutes.
At each of the 16 time-points, 3 optimal 10-second 12-lead ECGs were extracted with stable heart rates and maximum signal quality using Antares software (AMPS-LLC, New York City, NY). The resulting 5232 ECGs were up-sampled from 500 to 1000 Hz.
The raw directory contains the 5232 original extracted 10-second standard 12 lead ECG segments organized in subdirectories named after the subject number or randomization number
RANDID in the second column of the SCR-002.Clinical.Data.csv file. The ECGs are stored in standard MIT format, with a signal
.dat file and corresponding header
.hea file for each segment
The medians directory contains derived representative median beats for 5223 of the 5232 raw ECG segments. Median beats were obtained as follows: the median PQRST waveform (median cardiac beat) for each lead was calculated by sample-by-sample synchronization of the QRS complex, and beats of a nonsinus origin were excluded based on a cross-correlation coefficient and RR interval history .
There are also semi-automatic annotations of each median beat based on the vector magnitude lead, containing P onset, QRS onset, QRS offset, T peak, secondary T peak (if present) and T offset. The annotations are stored in standard MIT annotation format, with annotator extension
The SCR-002.Clinical.Data.csv file contains demographic information about the subjects, and important metadata about each ECG recording including their time-point, dosing period, associated drug, various beat intervals, and morphology measurements as described in Vicente et al. JAHA 2015. The spreadsheet column headings are described in the SCR-002.Clinical.Data.Description.txt file.
1. Improving the assessment of heart toxicity for all new drugs through translational regulatory science
Name Last modified Size Description
Parent Directory - ANNOTATORS 2016-06-27 17:13 29 list of annotators MD5SUMS 2016-09-15 15:42 348 RECORDS 2016-08-18 09:28 490K list of record names SCR-002.Clinical.Data.Description.txt 2016-08-18 09:35 1.9K SCR-002.Clinical.Data.csv 2016-07-26 16:27 1.2M SHA1SUMS 2016-09-15 15:42 404 SHA256SUMS 2016-09-15 15:42 572 medians/ 2016-07-13 09:09 - raw/ 2016-07-13 09:07 -
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Updated Friday, 28 October 2016 at 16:58 EDT