The CLI-AMP Registry

NCT ID: NCT04427124

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2023-12-31

Brief Summary

Single-center, observational registry study with a prospective and retrospective arm to evaluate the impact of multidisciplinary CLI teams and protocol on amputation rates, vascular studies, revascularization, in-hospital and long-term outcomes.

Detailed Description

It is well known from large Medicare and National Inpatient Sample databases that vascular evaluations in patients with critical limb ischemia (CLI) and at risk for amputations remains extremely low. However, this data is largely pulled from the early 2000s with a scarcity in studies from this recent decade. A recent study showed that Medicare patients from 2011 showed that 23% of patients received primary major amputation. In a recent retrospective analysis preformed at this institution, all amputation patients from 2011-2017 were evaluated for vascular work up and long-term mortality. This cohort included 698 patients with 1009 amputated specimens (major and minor). This means that this institution is preforming around 140 amputations per year, which can be considered unacceptably high. Only 50% received any form of vascular study (ankle-brachial index, doppler ultrasound, and computed tomography angiography) within the year prior to amputation. Furthermore, only 30% of patients received an angiogram within the year prior to amputation. In addition, all major amputations received histopathological analysis, which confirmed that 62% the specimens were graded with severe atherosclerosis. Even in this present decade, with the knowledge that CLI patients are not receiving proper evaluation and treatment leading to amputation which is associated with extreme mortality rates and a large economic burden, health care facilities are not improving their care.

Multidisciplinary teams are a recommendation from the American Heart Association/American College of Cardiology guidelines for managing peripheral vascular disease. Multidisciplinary team approaches in other cardiovascular diseases, such as structural heart disease, has long been validated. Literature regarding the implementation of "CLI Teams" remains scarce and not widely adopted. However, institutions that have implemented a CLI Team that engages with specialists from multiple disciplines have shown successful decrease in amputation rates and increases in vascular evaluations and revascularization in these patients. The goal for this study is to establish a hospital-based, physician and nurse led, multidisciplinary team to deliver comprehensive care to CLI patients. We believe it is important to document the experience of building a CLI Team and care protocols to provide insight and validated data for other programs to implement. The multidisciplinary team will include vascular interventionalists, hospitalists, podiatry, wound care, infectious disease, nephrology, orthopedics, pharmacists, emergency department physicians, mid-level providers, nursing staff, and vascular technologists. The ultimate goal is amputation prevention and wound healing through comprehensive vascular care and data driven patient outcomes.

Conditions

Critical Limb Ischemia; Peripheral Arterial Disease; Amputation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Prospective

Patients admitted into the hospital will receive care based on a multidisciplinary team approach and Institutional critical limb ischemia protocol.

Multidisciplinary Team Based Care Model

Intervention Type: OTHER

All prospective patients admitted into the study will receive care based on multidisciplinary team collaboration and an institutional protocol for critical limb ischemia.

Retrospective

A retrospective analysis of all patients with CLI admitted to the hospital from 2017-2019 will serve as a baseline comparator for overall CLI care and long-term mortality out to 2 years will be analyzed in the retrospective cohort using the national death index. Patients will be identified by the following ICD codes: 440.22 (ASVD of extremities with rest pain), 440.23 (ulceration), and 440.24 (gangrene).

No interventions assigned to this group

Interventions

Multidisciplinary Team Based Care Model

All prospective patients admitted into the study will receive care based on multidisciplinary team collaboration and an institutional protocol for critical limb ischemia.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• >18 years of age
• CLI of the lower extremity
• Willingness and ability to participate in the study and meet follow-up requirements

Exclusion Criteria

• Pregnancy
• <18 years of age
• Incarcerated patients
• Patients who receive amputations due to trauma or cancer
• Wound, gangrene, or amputation of the upper extremities
• Unwillingness or inability to participate in the study and meet follow-up requirements

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

Hendrick Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Joji Varghese

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Bailey A Estes, BSN

Role: CONTACT

baileyann1123@gmail.com

325-207-4734

Other Identifiers

CA10142019

Identifier Type: -

Identifier Source: org_study_id