Action to Control Cardiovascular Risk in Diabetes

Contract HHSN-271-2010-00023, Action to Control Cardiovascular Risk in Diabetes (ACCORD) - Memory in Diabetes (MIND) MRI Follow-Up Study, has been awarded to Wake Forest University Health Sciences.
The National Institute on Aging (NIA) is conducting a follow-up study to the clinical trial titled "The Action to Control Cardiovascular Risk in Diabetes (ACCORD) - Memory in Diabetes (MIND)". The follow-up study is a two-year effort to follow-up the original ACCORD-MIND subset of patients to acquire a third Magnetic Resonance Image (MRI) of the brain. ACCORD-MIND MRI is a sub-study in ACCORD, a randomized, multi-center, factorial designed clinical trial in 10,251 participants with type 2 diabetes mellitus. MIND MRI included 620 of these participants, and was conducted at four sites, and was managed through a central coordinating office and four clinical networks. The Coordinating Center includes a central MRI quality control and reading center. The goal of the ACCORD-MIND trial was to address the question as to whether three complimentary treatment strategies could reduce the risk for cognitive decline, or adverse changes in brain structure measured on MRI. The treatment strategies administered as a part of the main ACCORD trial were designed to compare standard vs. intensive control glycemia targeted to near-normal levels (target HbA1c < 6), to compare to placebo the effect of fibrates, which increase HDL-cholesterol and lower triglycerides, in the context of good LDL-C control, and of intensive BP control targeting the normal range (SBP< 120 mmHg). Specifically, ACCORD-MIND evaluates intensive glucose, blood pressure and lipid management as means to reduce detrimental changes in the brain structure and function.

PURPOSE AND OBJECTIVES: This contract will follow up MIND participants to acquire an additional measure of brain structure, and to expand the outcomes of the study to nursing home placement and to new clinical events that follow or precede measures of the brain. The objective of following up MIND participants is to further delineate how diabetes affects the brain. The aging of the cohort, longer follow-up and an additional MRI allow the study of the longitudinal effects of diabetes-related factors on the brain, and to investigate how these factors, in combination with older age, interact leading to worse outcomes. Specifically: the contract will investigate: 1) What changes and what is the trajectory of change in brain structure? 2) What are the risk factors associated with increased, as well as reduced risk for adverse changes in brain structure or function? 3) Do these changes increase the risk for dementia, nursing home placement or death? 4) How do the brain changes co-vary with the development of other diabetes co-morbidities such as retinopathy, nephropathy and neuropathy? and, 5) Do the changes predict prospectively collected data on fasting levels of glucose, A1C levels, and hypoglycemic events?

PROJECT REQUIREMENTS: The Contractor shall have overall responsibility for the coordination of Magnetic Resonance Imaging (MRI) activities that are a fundamental part of the ACCORD MIND Follow-Up Study. These activities include: 1) Recruitment of participants who previously participated in the ACCORD MIND sub-study. Recruitment muse be done in concert with the staff at the ACCORD clinics that are following the participants as part of the ACCORD Follow-up Study (NHLBI); 2) Acquisition, quality control, analysis, archiving, and retrieving of scans; 3) Updating and reviewing web-based activities; writing annual reports as required by the funding agency; 4) Deposition of data into a centralized database that houses other data from the ACCORD MIND MRI sub-study; 5) Analysis and collaboration on manuscripts based on this study and the previous ACCORD MIND MRI sub-study; 6) Monitoring progress of MRI field site activities, including: recruitment goals, successful scheduling for MRI appointments, completion of scan protocol, transmission of the scans to the Coordinating Center and adherence of quality control and reporting techniques; training and re-training of MRI staff as needed. Training of MRI technicians for the brain MRI should include the MRI scan protocol, scheduling and screening for participant MRI eligibility; quality control and transmission protocols; 7) Organization and implementation of training of staff at the local clinic that is following the MIND participants as a part of the larger main trial. Training should include: the purpose of the MRI, the logistics of identifying eligible participants, scheduling and rescheduling of appointments, and the process for addressing other issues that may routinely arise from participant questions or reasons for refusal; 8) Design and implementation of a Quality Control (QC) procedure for the MRI field sites that is appropriate for the four networks that have previously participated in the ACCORD MIND MRI sub-study; 9) Demonstration of comparability between the acquisition and analysis of MRI scans to the previously acquired and analyzed scans that are part of the ACCORD MIND MRI sub-study. Additionally, the Contractor shall collaborate with the MRI Study Data Coordinating Center (DCC) (MRI CC - Nick Bryan, University of Pennsylvania) to design and maintain: 1) a web link with the main study; 2) a procedure to identify and track participants eligible for the MRI study; 3) a statistically appropriate method to generate quality control statistics; 4) production of quality control reports and uploading to web-site; 5) statistical analyses for primary publications.

REPORTS AND DELIVERABLES: The following reports will be required: Monthly Technical Progress Report, Annual Technical Progress Report, and Final Report.
PERIOD OF PERFORMANCE: The contract period of performance is two (2) years (09/15/10 through 09/14/12).

This contract action was both cost-reimbursement and non-competitive. The uncertainties involved in contract performance do not permit costs to be estimated with sufficient accuracy to use any type of fixed-price contract; this requirement is not an acquisition of commercial items-it is an R&D procurement.

See attached Justification for Other Than Full and Open Competition.