NIH GUIDE, Volume 21, Number 43, November 27, 1992


P.T. 34, II


  Data Management/Analysis+ 

  Clinical Trial 

  Computer Storage & Retrieval 

  Cardiovascular Diseases 

National Heart, Lung, and Blood Institute

The primary objective of this project is to assess whether or not

interventions that modify lipoproteins will inhibit progression and

induce regression of coronary plaques in women; the secondary

objective is to elucidate the mechanisms by which various treatments

may modify atherosclerosis in women.  The study will consist of three

randomized angiographic trials with a common core protocol and a

single Clinical Coordinating Center.  Angiographic changes will be

primary endpoints of all three trials.  A total of 568 women with

angiographically documented coronary artery disease will be enrolled

to participate in one of three randomized therapeutic trials:  (1)

Hormone replacement therapy in postmenopausal women; (2)

Cholesteral-lowering diet and antioxidants; and (3) Drugs that lower

LDL-cholesterol versus drugs that, in addition, raise HDL-cholesterol

levels.  The program will comprise three phases.  During Phase I, the

Clinical Coordinating Center will participate with investigators from

three to six Clinical Centers to develop detailed protocols and

Manuals of Operations and to assume the responsibility for a

cooperative effort with other study investigators to develop,

pretest, reproduce, and distribute appropriate reporting forms.  The

Clinical Coordinating Center will also be responsible for

establishing and working with a central laboratory facility, a

central angiographic facility for quantitative coronary angiography,

and a drug distribution center.  The Clinical Coordinating Center

will design quality control and randomization procedures.  During

Phase II, the Clinical Coordinating Center will be responsible for

randomizing patients, monitoring recruitment, and collecting,

editing, storing, and analyzing data.  Throughout the course of the

study, the Clinical Coordinating Center will assume the

responsibility for review of the quality and timeliness of the data

transmitted.  The Clinical Coordinating Center will prepare reports

for the Data and Safety Monitoring Board that will monitor progress

of the program.  During Phase III, the Clinical Coordinating Center

will analyze the data and prepare and write scientific reports and

manuscripts for publication and presentation, in collaboration with

other study investigators and the National Heart, Lung, and Blood

Institute's Program Office.  One award is anticipated.  This

incrementally funded contract will be awarded for five years.

This announcement is not a Request for Proposals (RFP).  RFP

NHLBI-HV-92-42 will be released on or about November 25, 1992 with

proposals due on or about February 1, 1993.  One award is anticipated

by the Government.  The written request must include three

self-addressed mailing labels, and must cite RFP No. NHLBI-HV-92-42.


Request for copies of the RFP are to be sent to:

Sharon M. Kraft, Contract Specialist

HLVD Contracts Section, COB, DEA

National Heart, Lung, and Blood Institute

Bethesda, MD  20892

Telephone:  (301) 496-6815


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