SCOPE-CLI: Shifting Care and Outcomes for Patients With Endangered Limbs

Study Overview
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Brief Summary
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A research project capturing experiences of patients with critical limb threatening ischemia, with the ultimate goal of setting new standards for diagnosing, describing detailed patient-centered outcomes, and evaluating the variability in therapeutic approaches and their association with outcomes.

Detailed Description
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An estimated 8 million individuals in America are affected by peripheral arterial disease (PAD). One of its extreme expressions is Critical Limb Ischemia (CLI). It is one of the most severe vascular conditions associated with devastating outcomes, including poorly healing wounds, extreme pain, and a high amputation risk. It is also one of the deadliest conditions, with 6-month and 5-year mortality rates estimated to be 20 and >50%, respectively. To date, however, there is a paucity of prospective clinical evidence about the variability in patients' presentations, their management or their outcomes. Accordingly, little progress has been made in adequately staging the disease and to risk-stratify treatment approaches to patients' individual characteristics. What is desperately needed to advance the care and management of patients with CLI is a focused research effort to set new standards for diagnosing, describing detailed patient-centered outcomes, and evaluating the variability in therapeutic approaches and their association with outcomes. The specific aims of SCOPE-CLI are to generate new evidence on the clinical characteristics, treatment patterns and outcomes of patients with critical limb ischemia (CLI); to describe treatment patterns and variability across practices to identify gaps in delivering quality care; and to perform a series of analyses to examine the associations of patient and treatment characteristics with outcomes. The central objective of SCOPE-CLI is to systematically quantify patients' CLI-specific health status and clinical outcomes and to perform subgroup analyses as a function of different PAD treatments and patient characteristics.

Official Title
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SCOPE-CLI: Shifting Care and Outcomes for Patients With Endangered Limbs - Critical Limb Ischemia

Conditions
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Peripheral Arterial Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All race/ethnicity categories, English speaking, men and women Patient presents with current (within 30 days) Rutherford Class 4, 5, or 6 Age ≥18 years Supported by any of the following diagnostic evidence: Rutherford Classification 4 or ischemic rest pain and/or resting ankle pressure <50mmHg, flat or barely pulsatile ankle or metatarsal PVR or toe pressure <40mmHg Rutherford Classification 5 or minor tissue loss; non-healing ulcer, focal gangrene with diffuse pedal ischemia resting ankle pressure <50mmHg ankle or metatarsal PVR flat or barely pulsatile or toe pressure <40mmHg Rutherford Classification 6 or major tissue loss: extending above transmetatarsal level, functional foot no longer salvageable, resting ankle pressure <50mmHg ankle or metatarsal PVR flat or barely pulsatile or toe pressure <40mmHg CLI related ICD 10 code (reason for admission or indication for procedure) SPP < 50 mmHg TCPO2 < 50 mmHg Angiographic evidence no straight line to foot or greater than 70% stenosis in all 3 lower extremity arteries (AT, PT, peroneal) ABI* ≤ 0.90 non-compressible ABI ≥ 1.40 AND TBI ≤ 0.70 TBI* ≤ 0.70 Exclusion Criteria: Acute limb ischemia Unable to provide written informed consent Currently a prisoner (identified at time of enrollment)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral Artery Questionnaire (PAQ) | PAD-specific, multi-dimensional health status instrument with a CLI specific module. Higher scores indicate better functioning. | After enrollment and follow-up at month 1 | 
| Peripheral Artery Questionnaire (PAQ) | PAD-specific, multi-dimensional health status instrument with a CLI specific module. Higher scores indicate better functioning. | After enrollment and follow-up at month 2 | 
| Peripheral Artery Questionnaire (PAQ) | PAD-specific, multi-dimensional health status instrument with a CLI specific module. Higher scores indicate better functioning. | After enrollment and follow-up at month 6 | 
| Peripheral Artery Questionnaire (PAQ) | PAD-specific, multi-dimensional health status instrument with a CLI specific module. Higher scores indicate better functioning. | After enrollment and follow-up at month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse limb events (MALE) | Major adverse limb events include: major amputation above the level of the ankle joint, thrombolysis/thrombectomy or surgical bypass or graft revision, after diagnostic or interventional lower extremity angiography) | 6 months after enrollment | 
| Major adverse limb events (MALE) | Major adverse limb events include: major amputation above the level of the ankle joint, thrombolysis/thrombectomy or surgical bypass or graft revision, after diagnostic or interventional lower extremity angiography) | 12 months after enrollment | 
| Major adverse limb events (MALE) | Major adverse limb events include: major amputation above the level of the ankle joint, thrombolysis/thrombectomy or surgical bypass or graft revision, after diagnostic or interventional lower extremity angiography) | 5 years after enrollment | 
| Amputation Free Survival (AFS) | AFS will be a measure of number of patients free from death or above ankle amputation | 6 months after enrollment | 
| Amputation Free Survival (AFS) | AFS will be a measure of number of patients free from death or above ankle amputation | 12 months after enrollment | 
| Amputation Free Survival (AFS) | AFS will be a measure of number of patients free from death or above ankle amputation | 5 years after enrollment | 
| Mortality - Death | Vital status obtained from either medical records or social security death index will be assessed to account for number of patients who died | 6 months after enrollment | 
| Mortality - Death | Vital status obtained from either medical records or social security death index will be assessed to account for number of patients who died | 12 months after enrollment | 
| Mortality - Death | Vital status obtained from either medical records or social security death index will be assessed to account for number of patients who died | 5 years after enrollment |