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COMMERCE BUSINESS DAILY ISSUE OF OCTOBER 21,1997 PSA#1955National Heart, Lung, and Blood Institute, NIH, Contracts Operations
Branch, II Rockledge Building, MSC 7902, 6701 Rockledge Drive,
Bethesda, MD 20892 A -- SUBCLINICAL CARDIOVASCULAR DISEASE STUDY, ELECTRON BEAM COMPUTED
TOMOGRAPHY READING CENTER SOL NHLBI HC-98-12 DUE 011498 POC Cheryl A.
Jennings, Contracting Officer, Internet Address cj19f@nih.gov,
telephone 301-435-0345, facsimile 301480-3430 The National Heart, Lung,
and Blood Institute (NHLBI) is soliciting proposals from
organizations/institutions to conduct an epidemiology study of
subclinical cardiovascular disease. This Request for Proposals (RFP)
NHLBI-HC-98-12 is for the Subclinical Cardiovascular Disease Study,
Electron Beam Computed Tomography (EBCT) Reading Center. The
Subclinical Cardiovascular Disease Study is a study of the
characteristics of subclinical cardiovascular disease (disease detected
non-invasively before it has pr oduced signs and symptoms) that predict
progression to clinically overt cardiovascular disease in a diverse and
representative population-based sample of men and women aged 35-84.
Eighteen thousand men and women aged 35 to 84 will be recruited for an
initial examination in this prospective study. The broad age range
will permit analysis of important interactions between age and risk
factor-subclinical disease relationships and between age and
subclinical disease-event relationships. The large total numbe r is
necessary to ensure the accrual of a sufficient number of coronary
heart disease events over a five- to six-year morbidity and mortality
follow-up period. Initial recruitment will be population-based with the
goal of enrolling approximately 50% minority participants, including
roughly equal numbers of non-Hispanic blacks, Hispanics, and Pacific
Islanders/Asians. The study will involve six to eight Field Centers, a
Coordinating Center (which will subcontract for a Central Lipid
Laboratory), a Special Laboratory Center; and separate Reading Centers
for Ultrasonography, Magnetic Resonance Imaging, and Electron Beam
Computed Tomography (EBCT). To allow for the expected continued rapid
evolution of subclinical disease measures in the next few years, the
choice of the most appropriate screening measure will be made during
final protocol development in collaboration with study investigators.
The timeline for this study will begin with an initial 18-month
protocol planning, OMB clearance, pilot testing and training period.
This will be followed by a two-year screening examination for all
participants to identify the highest risk groups in
age-race/ethnicity-gender-specific strata. A subsample of participants
at the highest end of the subclinical disease distribution and a
random sample will undergo a comprehensive examination within 6 months
of screening. The comprehens ive examination will include more
detailed measures of large and small vessel disease as described below.
The numbers of participants in these subsamples will be determined
during protocol development, based on the estimated power to conduct
analyses of risk factors for subclinical disease progression and
development of clinical events and for comparing the high risk
subsample and random sample to identify relationships between risk
factors and subclinical disease. For purposes of power and sample size
es timation, each subgroup was assumed to be 10% of the total cohort,
with oversampling of the high-risk group to compensate for medical and
surgical intervention. The remaining participants (those not in either
subsample) will not be periodically re-examined as is typically done
in traditional epidemiologic studies; rather, they will be contacted
annually for ascertainment of morbidity and mortality only. For the
high risk and random sample subgroups, follow-up examinations at
periodic intervals (e.g., 6-12 months) will focus on biochemical and
other factors more proximally associated with events. Smaller subsets
of particular interest may be selected to undergo more frequent
follow-up or specialized examinations particularly for subclinical
disease. The timing and composition of repeat subclinical disease
measures will depend on the temporal nature of the measurement in its
relation to clinical outcomes, demonstrated reliability of the
measurement techniques in this population, the relationships found
among measures, and the specific measures found most likely to progress
to clinically overt events. The subsamples will also be followed for
morbidity and mortality for a five- to six-year period, to allow
accrual of a sufficient number of fatal and nonfatal events for
completion of study objectives. The original cohort of 18,000 will also
be followed for events, to allow relationships between screening
variables and events to be analyzed. Completion of morbidity and
mortality follow-up for the study will be followed by a period of final
data analysis and study close-out, bringing the contract period to a
total of 10 years. There will be one award. The period of performance
is anticipated for ten years in September 1998. The Request for
Proposal (RFP) NHLBI-HC-98-12 will be available on or about November 3,
1997, with proposals due January 14, 1998. Offerors other than United
States of America institutions will not be considered based on the need
for scientifically comparable data. This solicitation and instructions
may be accessed upon release through the NIH Home Page or the NIH
Gopher by using the following electronic m ail addresses and
instructions. To access the RFP through the NIH Gopher: Go to the URL
(Universal Resource Locator) gopher://gopher.nih.gov:70/11/res/rd-rfp.
Select RFP's Available, then NHLBI. A list of RFP's will appear.
Select RFP No. NHLBI-HC-98-12. To access the RFP through the World Wide
Web (WWW): Go to the NIH Home Page at URL http://www.nih.gov. At the
NIH Home Page, select Grants and Contracts, then select the Contracts
Page. Next select the NIH Gopher Directory. The URL for the NIH Goph er
Directory is gopher://gopher.nih.gov:70/11/res. From the Gopher menu,
select R&D Request for Proposals, then select RFPs Available, then
select NHLBI. Select RFP NHLBI-HC-98-12. Follow the directions for a
Streamlined Technical RFP. All information required to submit an offer
is in the electronic RFP package. Point of contact: Cheryl A.
Jennings, Contracting Officer, Internet electronic mail address
cj19f@nih.gov, telephone 301-435-0345, facsimile 301-480-3430. No
collect calls will be accepted. Y our request should cite "RFP
NHLBI-HC-98-12." (0290) Loren Data Corp. http://www.ld.com (SYN# 0010 19971021\A-0010.SOL)
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