Critical Limb IschemiaCLI-AMPNCT04427124
The CLI-AMP Registry
An observational study of Critical Limb Ischemia and Peripheral Arterial Disease, run by Hendrick Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Limb Ischemia, Peripheral Arterial Disease, Amputation
- What is being tested?
- Multidisciplinary Team Based Care Model
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2020to 31 Dec 2023
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Critical Limb Ischemia
Who may be able to join
- >18 years of age
- CLI of the lower extremity
- Willingness and ability to participate in the study and meet follow-up requirements
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Multidisciplinary Critical Limb Ischemia Team on the Utilization of Vascular Studies, Patient Management, AMPutation and Long-term Outcomes: The CLI-AMP Registry
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.
Read the 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.
- Being tested
- Multidisciplinary Team Based Care Model
- Keywords
- Critical Limb Ischemia, Peripheral Arterial Disease, Amputation
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary Team Based Care ModelOther
All prospective patients admitted into the study will receive care based on multidisciplinary team collaboration and an institutional protocol for critical limb ischemia.
| Study group | Role | What they receive |
|---|---|---|
| Prospective | Patients admitted into the hospital will receive care based on a multidisciplinary team approach and Institutional critical limb ischemia protocol. Receives: Other: Multidisciplinary Team Based Care Model | |
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of major amputations within the hospital
Decreased percentage
Measured: 2 years
Change in in-hospital and long-term mortality rates
Measured: 2 years
Secondary outcomes (4)
Change in the percentage of non-invasive vascular evaluations in patients with CLI and at risk for amputation (ABI, DUS, CTA)
Measured: 2 years
Change in percentage of patients receiving invasive angiogram and revascularization (Endovascular or Surgical).
Measured: 2 years
Change in wound healing
Decrease in Rutherford Classification
Measured: 2 years
Change in hospital length of stay
Decrease in days
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Aug 2020 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Hendrick Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Joji Varghese, Hendrick Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427124
- Sponsor's protocol ID
- CA10142019
- Acronym
- CLI-AMP
- Status last verified
- Jun 2020
- First submitted
- 6 May 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Multidisciplinary Critical Limb Ischemia Team on the Utilization of Vascular Studies, Patient Management, AMPutation and Long-term Outcomes: The CLI-AMP Registry
- ClinicalTrials.gov ID
- NCT04427124
- Acronym / sponsor ID
- CLI-AMP / CA10142019
- Keywords
- Critical Limb Ischemia, Peripheral Arterial Disease, Amputation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hendrick Medical CenterUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective | – | Other: Multidisciplinary Team Based Care ModelPatients admitted into the hospital will receive care based on a multidisciplinary team approach and Institutional critical limb ischemia protocol. |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Critical Limb Ischemia
Key inclusion criteria (3 listed)
- >18 years of age
- CLI of the lower extremity
- Willingness and ability to participate in the study and meet follow-up requirements
Key exclusion criteria (6 listed)
- Pregnancy
- <18 years of age
- Incarcerated patients
- Patients who receive amputations due to trauma or cancer
- Wound, gangrene, or amputation of the upper extremities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary Team Based Care ModelAll prospective patients admitted into the study will receive care based on multidisciplinary team collaboration and an institutional protocol for critical limb ischemia. | Other | Prospective |
Primary outcome
Change in the number of major amputations within the hospital
Time frame: 2 years
Decreased percentage
Change in in-hospital and long-term mortality rates
Time frame: 2 years
4 secondary outcomes
Change in the percentage of non-invasive vascular evaluations in patients with CLI and at risk for amputation (ABI, DUS, CTA)
Time frame: 2 years
Change in percentage of patients receiving invasive angiogram and revascularization (Endovascular or Surgical).
Time frame: 2 years
Change in wound healing
Time frame: 2 years
Change in hospital length of stay
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Limb Ischemia and Peripheral Arterial Disease, run by Hendrick Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bailey A Estes, BSN (325-207-4734, baileyann1123@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of major amputations within the hospital (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.