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PHASE VII

Announcement: The Strong Heart Study (SHS) will be conducting a Phase VII exam of all consenting participants February, 2022 to February, 2024. The exam is intended in part to serve as a platform for additional, independently funded exam components via investigator-initiated grants or other independently funded projects to enrich the exam data collection with additional hypothesis-driven content. The research aims of such exam-related ancillary projects need not be limited to those within the mission of the NHLBI but must be consistent with and/or complement the SHS’s objectives. Please read below for more information on Ancillary Study opportunities.

 Ancillary Studies to the SHS Phase VII Participant Re-exam

The NHLBI has issued contract awards to support the Strong Heart Study (SHS) infrastructure during a Phase VII (beginning February, 2019 for a seven-year duration). Support for a basic follow-up examination of approximately 3,500 participants during the contract cycle will be included. The SHS exam will serve as a platform for in-depth ancillary studies that are funded outside of the SHS contracts. These ancillary studies will be operationally integrated into the main study, and can propose additional exam components. (See NOT-HL-19-687)

The SHS is Soliciting Ancillary Studies

Interested investigators are encouraged to contact the SHS investigators at https://strongheartstudy.org/Contact-Us#383111813-directory-of-investigators to begin planning ancillary study proposals. In addition, the SHS is soliciting ancillary study ideas to be presented at their June, 2019 SHS Steering Committee Meeting to be held at the University of Oklahoma Health Sciences Center (tentatively scheduled for June 11-12). Study ideas can be presented and discussed through brief presentations, either in-person or through videoconferencing. Check back for additional details regarding timing and format.

SHS Phase VII exam Components

For planning purposes, the components of the basic core examination will include the following: recruitment, informed consent, blood pressure and anthropometry measurements, phlebotomy and spot urine for key lab analytes (serum lipid profile, plasma glucose, whole blood HbA1c; and urinary creatinine and albumin) and sample storage for future research use, and questionnaires to update personal and medical history and current medications use.

SHS Phase VII Exam Timing:

Planning of exam components, obtaining IRB and Tribal Approvals:

February 15, 2021 to February 14, 2022

Phase VII exam:

February 15, 2022 to February 14, 2024

The SHS invites investigators to discuss ideas for potential collaborations/ancillary studies with the SHS investigators at the SHS Steering Committee meeting, scheduled for June 11-12, 2019 in Oklahoma City, Oklahoma.