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Improving Chronic Limb Threatening Ischemia Across the US

Award Number: R01HL178865
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/22/2026
PERIOD OF PERFORMANCE END DATE: 03/31/2030

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Improving Chronic Limb Threatening Ischemia Across the US - Approximately 8.5 to 12 million Americans have peripheral artery disease (PAD). Chronic limb-threatening ischemia (CLTI), a severe form of PAD, accounts for the majority of amputations. Healthcare costs related to PAD are estimated at over $6 billion annually. Some populations, such as rural residents, experience higher rates of CLTI than other groups. In addition, data on sex differences in CLTI is limited. Although ankle-brachial index (ABI) is a useful tool for diagnosing PAD in community populations, ABIs have not been consistently associated with future CLTI or amputation. Social determinants of health (SDoH) likely contribute to differences in CLTI events; however, knowledge gaps remain related to community-level and individual-level SDoH factors, particularly among populations such as rural residents. The American Heart Association (AHA) recently published a statement on health disparities in PAD, calling for community-based studies that examine risk factors for CLTI by race and SDoH. The REasons for Geographic And Racial Differences in Stroke (REGARDS) study provides a unique longitudinal cohort in which to examine rates of CLTI events among community-dwelling Black and White adults residing across the continental US, with detailed information on SDoH.18 Half of REGARDS participants are from the Southeastern states where the prevalence of PAD risk factors is high, half of participants are women, and more than 40% of participants are Black. REGARDS has recently been renewed, allowing for CLTI follow-up through 2027. Although multiple CVD outcomes have been rigorously assessed in REGARDS, currently, PAD assessment is limited to self-report. The objective of this application is to leverage the REGARDS study to identify individual and contextual risk factors for CLTI and examine contributors to disparities in CLTI. This current study will provide unique data on CLTI in one of the largest longitudinal community cohorts in the US through the adjudication of incident and recurrent CLTI events, including amputations and revascularizations. We propose to adjudicate CLTI events, including hospitalizations, revascularizations, and amputations among REGARDS participants. We will examine the role of SDoH in the incidence and recurrence of CLTI and examine the underlying causes of the sex-related differences in CLTI events. Lastly, this proposal will support the training of investigators in the area of PAD/CLTI. This proposed study will leverage a large cohort with extensive data on PAD and CVD risk factors, CVD outcomes, and SDoH to improve the current understanding of those at particular risk for CLTI. These data will inform health policy, in addition to public health and clinical interventions, which lead to the prevention of PAD, with the goal of reducing CLTI events while improving PAD-related health for all.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $735,327 )
2026	2026	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Cardiovascular Diseases Research	000	1	6/26/2026	NEW	$735,327
														Subtotal = $735,327

Grand Total All Awards = $735,327

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Improving Chronic Limb Threatening Ischemia Across the US

Award Number: R01HL178865

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 06/22/2026

PERIOD OF PERFORMANCE END DATE: 03/31/2030

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