The NHLBI has issued contract awards to support the Strong Heart Study (SHS) infrastructure and continued surveillance 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 Phase VII 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.
Ancillary Studies to the SHS Phase VII Participant Re-exam
The SHS Phase VII exam of all consenting participants will occur Nov 1st, 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. Interested investigators are also encouraged to see NOT-HL-19-687 and references therein for suggested submission dates to allow adequate time to cooperate with the SHS in the planning of the SHS Phase VII exam.
Ancillary Studies Approved
The following ancillary studies we approved to be conducted alongside SHS Phase VII examination:
• Gut Microbiome, Aging and Cardiometabolic Diseases in American Indians (PI: Jinying Zhao)
• Psychological Risk Factors, Quality of Life, Community, and Brain Aging in American Indians (PI: Celestina Barbosa-Lieker & Astrid Suchy-Dicey)
• The Epitranscriptome as a Novel Mechanism of Arsenic-Induced Diabetes (PI: Ana Navas-Acien)
• Resilience, Cultural Alignment, and Social Support in Brain Aging (PI: Astrid Suchy-Dicey): Data from the Strong Heart Study
• Health Effects of Metals in Native American communities: A Longitudinal Multi-omics Study (PI: Ana Navas-Acien)
• Chronic Respiratory Diseases in American Indians(PI: Huimin Wu) *Oklahoma Field Center only*
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: November 1,2022 to October 31,2024
Phase VII Manual of Operations (PDF)
Phase VII ICD9 and ICD10 crosswalk
Phase VII - MNL MAC5 OPERATOR MANUAL
Phase VII Data Forms (PDF)
Phase VII Data Dictionary (PDF)
MM Fillable Forms Page