Clinical Research Program

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Clinical Research Program

keyboard overlaid with human vasculature map.The clinical research program prospectively defines key individual and national vascular health goals; creates regional and national vascular care health metrics; and translates successful programs into national scientific registries, prospective clinical trials, and care guidelines. The Program’s academic success is manifested by its dissemination of high quality outcomes data in over 250 peer-reviewed, high impact manuscripts by Dr. Hirsch, and nearly 800 manuscripts by the section faculty.

 

 

Landmark Clinical Research Programs

Great science is an art. We are proud to have created landmark clinical research programs.

Minnesota Regional PAD Screening Study

Minnesota Regional PAD Screening Study

The Vascular Medicine Program was instrumental in creating the Minnesota Regional PAD Screening Study, which was expanded to become the landmark national PARTNERS study of early PAD detection via use of the ABI measurement in primary care practices. This provided the basis for the phrase “PAD is prevalent, under-diagnosed and under-treated”.

Related Article:
Hirsch AT, Halverson S, Treat-Jacobson D, Lunzer MA, Hotvedt PS, Krook S, Rajala S, Hunninghake DB. "The Minnesota Regional Peripheral Arterial Disease Screening Program:  Toward a Definition of Community Standards of Care." Vascular Medicine 2001;6(2):87-96.

REACH registry

REACH registry

The Program provided vascular disease leadership to the international REACH registry that measured the cardiovascular risk of PAD, coronary heart disease, and stroke patients, by defining both annual ischemic event rates, limb outcomes, and predictors of adverse events. This study provided the basis for the phrase “PAD is known to be amongst the most morbid and mortal of all cardiovascular diseases.”

Related Articles:

FRIENDS registry

FRIENDS registry

Creation of the FRIENDS registry has defined contemporary acute limb ischemia and critical limb ischemia outcomes, including major adverse cardiac event rates and major adverse limb event rates. FRIENDS clarifies that “time is leg.” This study provides hope that timely detection of severe PAD, prompt revascularization, and provision of risk reduction therapies can improve the survival of life and limb. Great care requires that all aspects of excellence be achieved.

Related Articles:

Vascular health service and health economic research

Vascular health service and health economic research

We promote vascular health service and health economic research. This program was the first to measure the USA health economic costs of PAD; the clinical and cost impacts of tobacco use in individuals with PAD; has mapped county-based rates of ischemic amputation, heart attack and stroke across Minnesota; and evaluated the impact of atrial fibrillation on systemic (non-stroke) thromboembolic events. We lead the evaluation of the prevalence of lymphedema and impact of therapy on clinical events and cost.

Related Articles:

National multicenter randomized clinical trials

National multicenter randomized clinical trials

As a leader in the design, operation, and publication of major national multicenter randomized clinical trials, the section provided contributed to the evaluation of the only approved claudication medication (cilostazol), the first PAD-specific anti-thrombotic medication (clopiodrel) and evaluates most promising new PAD-specific medications. The section provided leadership to the NHLBI-sponsored CLEVER (PAD claudication comparative effectiveness), CORAL (renal artery stenosis comparative effectiveness) and current BEST (PAD critical limb ischemia comparative effectiveness) clinical trials. Dr. Hirsch serves as national co-principal investigator for the NIH-sponsored PACE clinical trial within the Cardiovascular Cell Therapy Research Network that evaluates the benefit, risk, and physiologic effects of autologous stem cell therapy for individuals with PAD and claudication.

Related Articles:

Vascular population health

Vascular population health

As individuals, we thrive best in healthy communities. Vascular diseases elicit profound impacts on population health. Most “vascular medicine” programs are focused on creating individual (or regional) clinical care pathways, in the absence of a broader population health mission. In contrast, the University of Minnesota section has established national leadership in promoting vascular population health.

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Minnesota Heart Health Program

Minnesota Heart Health Program

Cardiovascular prevention is vascular medicine: In 2011, section leadership – in partnership with the Lillehei Heart Institute and the School of Public Health – created the new Minnesota Heart Health Program's aspirin primary prevention initiative, called the "Ask About Aspirin" Initiative. With NIH RO1 funding, this effort is designed to promote ideal primary prevention of a first heart attack or stroke in appropriate high risk individuals. This is achieved by translating national prevention recommendations into discrete actionable steps for use by every primary care clinic across every health system in the state. Clinically effective and cost-effective national care is achieved when we act as though “prevention is an intervention”. This program will expand to include the first-ever program to prevent PAD and its adverse cardiac and limb events (“Project PAD”).

Related Articles:

Health policy development

Health policy development

From evidence to national guidelines, scientific statements, and government service: From this clinical care and clinical research base, section leadership has helped lead efforts to translate this experience into creation of the national 2005 and 2010 ACCF-AHA Guidelines for the Management of Patients with Peripheral Artery Disease; and the 2012 AHA "A Call to Action: Women and PAD" Scientific Statement. The section provides guidance to the FDA Cardiac and Renal Drugs Advisory Panel and recent Medicare Evidence Development & Coverage Advisory Committee meetings.

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At the University of Minnesota, “vascular medicine” is uniquely strong: We embrace both ideal individual and community health.