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Rochester Ventricular Repolarization Center
- QT..Resolutions,
Comprehensive Services
European
and American regulatory authorities are now
evaluating all new chemical entities to determine if
these entities have any effect on cardiac
repolarization. Pre-clinical cardiac repolarization
data and precise measurements of the QT interval and
other repolarization-related phenomena on the surface
ECG are being used to define whether an effect is
present. The proper balance between pre-clinical and
clinical studies during Phases I, II and III will
require careful consideration of the risks and
utilities of the variety of tests available. The CPMP and FDA guidelines on these topics are general
and are not a recipe of any kind for drug developers
who have to consider these issues.
The science of cardiac
repolarization is evolving rapidly, and a thoughtful
approach is required to tackle the scientific,
medical, drug development and regulatory issues
required to bring a safe and effective drug to
market. In light of our long-term interest,
experience and expertise in the area of cardiac
repolarization, we are initiating a new service in
Europe and the United States, QT..RESOLUTIONS, to provide drug developers
with "one-stop" advisory, delivery and
consultation services focused on evaluating the
potential of a drug to effect cardiac repolarization.
Over the past decade, we have acquired a unique
experience in the analysis of the repolarization
effects of many drugs, including anti-histamines,
anti-psychotics, prokinetics, and the conazole,
macrolide and quinolone antibiotics. QT..RESOLUTIONS offers a menu of
pre-clinical electrophysiologic, clinical and
regulatory ECG, quantiative repolarization, and
consultative services.
A word about our name,
QT..RESOLUTIONS. Why the dots? The two dots
symbolize that there is more to drug-related
repolarization evaluation than just measurement of
the QT interval, i.e., there are ion channel
kinetics, static and dynamic T-wave phenomena, T-wave
morphology, the U wave, etc., that can be affected by
drugs. Changes in the QT interval are currently the
gold standard for evaluating drug effects on
ventricular repolarization. Important additional
electrophysiologic parameters of ventricular
repolarization can now be measured. Such parameters
complement QT measurement in drug-safety testing and
screening, and these measures are becoming
increasingly utilized and relied upon by regulatory
agencies in the drug approval process.
The RVRC is one of the
activity of the Heart Research Follow-up Program
(HRFUP) which has more than 20 years of research
experience in quantitative analysis of ventricular
repolarization involving animals, normal subjects,
patients with genetic (Long QT Syndrome ) and acquired
(coronary disease and hypertension) cardiac
disorders, and in patients exposed to drugs that
affect the QT/U waves of the ECG.
Our group has an unique expertise in
the non-invasive evaluation of ventricular repolarization. Our laboratory
has published extensively in major journals on factors influencing
ventricular repolarization.
- Director:
A. J. Moss, MD; Professor of Medicine
(Cardiology)
- Co-Director:
W. Zareba, MD, PhD ; Associate Professor of
Medicine (Cardiology)
- Assistant
Director: JP. Couderc, PhD ; Assistant
Professor of Medicine (Cardiology)
- Business
Manager: M.W. Brown, MD; Manager HRFUP
- Corporate
Liaison: C Dunn, MD; Director Clinical
Research Institute
Our group consists of physicians, pharmacologists,
bio-engineers and technicians working together for a better understanding
of the information recorded on the surface ECG. The RVRC service
includes a Digital ECG core Lab that has a long history of research in ECG
signal processing. This core Lab a large toolbox of customized-software
has been designed for the analysis of the repolarization segment
on the surface ECG for the analysis of repolarization segment based
on electrocardiographic and vectocardiographic concepts equiped
with various types of ECG devices (from the recorders to the software
analysis).
RVRC developed the
methods for quantitative processing and analysis of
digitally recorded ECGs and provides this service to
pharmaceutical and device companies. The developed
analytic approaches permit precise and reliable
measurements of the repolarization segment that are
described in the following links:
1) QT and
QTc duration measurements
2) T-wave
area
3) QT/RR
relationship
4) Morphology
of the repolarization
The specially
designed, validated, digital-based analytic programs
permit detailed repolarization analysis from
electrocardiographic signals obtained on all
currently available digital ECG and Holter equipment.
Clients of RVRC have included major pharmaceutical
and device companies. The best evidence for our past
and ongoing activity is provided by the fact that our
group has served as central ECG, Holter and SAECG
core lab for several large NIH
sponsored studies and trials.
Heart Research Follow-up Program ECG
Core Lab is prepared to conduct analysis of all types of ECG recordings
including a standard 12-lead ECG, signal-averaged ECG, digital high-resolution
ECG and analog or digital long-term 24-hour Holter recordings. Over
several years of conducting the NIH and industry sponsored large
clinical studies and trials we have developed an expertise in the
central coordination and analysis of ECG recordings. Our Digital ECG core LAB
is equipped with the a large set of ECG recorders and analyzer including
digital devices from all the major american and European companies.
The RVRC is fully prepared to conduct computer analyses of various
high-resolution and long-term digital ECG recordings. We have in
operation computer programs which interpret various aspects of ECG
changes, including not only repolarization analysis in standard
and long-term recordings,as descibed before but also P-wave, QRS
signal-averaging, and heart rate variability analyses.
The above ECG-analytic
facilities are merged with a central computer
clinical data management that has been developed and
validated over last 20 years.
Our ambulatory and
hospital facilities at Strong Memorial Hospital,
which is the only big university hospital in the
metropolitan area with a broad referral network,
provide an excellent opportunity to enroll patients
in any kind of clinical study or trial. The best
proof for the above is provided by the active
involvement of our hospital group.
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