 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
 |
 |
 |
 |
 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
 |
 |
 |
 |
 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
 |
 |
 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
CRSTI Research NewsNovember 2002
The primary study objective is to determine the safety and efficacy of low-dose enoximone therapy in subjects with advanced chronic heart failure. The study results will seek to demonstrate that, compared to placebo, low-dose enoximone will decrease hospitalization rates, decrease mortality and morbidity, improve quality of life, improve symptoms of heart failure and decrease the associated costs of caring for individuals with advanced heart failure. The minimum and maximum duration of the study is expected to be 12 and 30 months respectively, with an average participation of 21 months. Approximately 700 patients may take part in this study in North and South America. We are expecting to enroll 20-30 patients locally. CRSTI is the only participating site in the Dallas area and is looking forward to this clinical trial. Two of the CRSTI physicians are directly involved in the trial. Dr. Eric J. Eichhorn is the lead investigator for all of the involved sites worldwide and Dr. J. Edward Rosenthal is the primary investigator for the Medical City Dallas site. Oral enoximone has undergone
extensive clinical investigation over the past 15 years. Overall, there
have been more than 80 separate studies conducted with this drug as
part of the Phase II clinical development program. More than 5,000 subjects
have been enrolled in these studies. It was shown that higher doses
of enoximone, administered to stable heart failure subjects, may be
associated with an adverse event rate in excess of that of placebo-treated
subjects. However, when administered chronically in lower doses to pre-transplant
patients with advanced heart failure, enoximone appeared to be well
tolerated, allowed weaning from IV inotrope therapy, and was associated
with a lowering of New York Heart Association functional class, and
was not associated with increase in death rate compared to a control
group at lower risk for morbidity and mortality.
These data suggest that enoximone may be an effective palliative treatment
for advanced heart failure and we, at CRSTI, are optimistic about our
contribution to this important clinical trial.
As
Clinical Research Coordinator, Natasha will work closely with both physicians
and patients, assuring Natasha graduated from Odessa State University, Odessa, Ukraine, with a Bachelor of Art in English, minoring in linguistics. She then graduated with an Associate of Science Degree in Nursing from Southwestern Adventist University, Keene, Texas. Natasha has worked as a registered nurse in various nursing fields, concentrating most of her recent career in research. Natasha
will concentrate most of her time working on heart failure studies and
is excited about expanding her cardiovascular research experience. Calendar
2003 Intern Program: Application Deadline Set for February Applications will be accepted for the 2003 Internship program beginning February 1, 2003. A new addition to the program is the independent research position for those students who have completed the formal internship and would like to work again with CRSTI on a research project. These students will not follow the formal rotation system, but rather work exclusively on their project with the assistance of their physician and staff mentors. This program was created last year when three previous interns expressed an interest to work with CRSTI again on a research project. A total of six students were involved in last year's summer programs; three participated as formal interns and three as independent research students. CRSTI Intern Program Director, Michelle Borg-Bruns, is not surprised, “The students have such a unique and positive experience here. It is understandable that they would want to come back again and again.” As the program has evolved over the years, so have the number of applicants. The number of applications received has tripled in the past three years. Michelle Borg-Bruns believes this trend will continue, "Each year we have seen an significant increase in the number of students wanting to participate in our Internship program, the word is out there - we have a quality program that provides students with a rare and unique opportunity." It is expected that more than twenty students will apply for each intern position available. Purpose Method Two weeks
will be spent in Quality and Outcomes, experiencing the data collection,
analysis, and statistical review used in improving patient care delivery.
Students will spend one week of concentrated clinical experience, shadowing
physicians and health care professionals who are recognized nationally
and internationally as pioneers in the field of cardiovascular medicine;
and observing procedures such as angiograms, bypass surgery and transplantation.
And finally, two weeks are dedicated to the completion of a research
project. Interns will be given a research project assigned at the beginning
of the internship, For the 2003
program, CRSTI will accept applications throughout the month of February.
After careful review of the applications, selected students will be
granted an interview to be conducted during March. In Their Own Words . . . "Interning
with CRSTI exposed me first hand to aspects of the medical profession
I had previously overlooked … I found the research rotation fascinating
and continue my deep interest in cardiothoracics." “This
program was extremely beneficial to fostering my education about medicine,
and helped to confirm and build my determination in entering the medical
field.” “I learned
more in eight weeks than I could ever learn in a semester at school,
and the practical real-world experience is something I could never get
from the classroom. This was truly an intensive, hands-on Happy Holidays The CRSTI
office will be closed on the following dates for the holidays:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||