Clinical trial NCT04710563: SCOPE-CLI: Shifting Care and Outcomes for Patients With Endangered Limbs
Official title: SCOPE-CLI: Shifting Care and Outcomes for Patients With Endangered Limbs - Critical Limb Ischemia
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Peripheral Arterial Disease
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: University of Chicago
name: Oregon Health and Science University
name: University of California, Davis
name: University of Southern California
name: Baylor College of Medicine
name: The Cleveland Clinic
name: Emory University
name: Brown University
name: Columbia University
name: University of Minnesota
name: Saint Luke's Health System
name: Abbott
name: Janssen Scientific Affairs, LLC
First posted: 2021-01-14
Enrollment: 458
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be enrolled from a range of clinical practices combining forces from vascular surgery, vascular medicine (interventional) cardiology, wound care specialists and podiatry clinics that treat CLI patients. All patients will be medically stable, i.e., not actively experiencing a life-threatening critical condition for which emergent care processes are ongoing, before they are approached for inclusion in the study.

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. All race/ethnicity categories, English speaking, men and women
2. Patient presents with current (within 30 days) Rutherford Class 4, 5, or 6
3. Age ≥18 years
4. 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:

1. Acute limb ischemia
2. Unable to provide written informed consent
3. Currently a prisoner (identified at time of enrollment)

Primary outcomes:
measure: Peripheral Artery Questionnaire (PAQ)
timeFrame: After enrollment and follow-up at month 1
measure: Peripheral Artery Questionnaire (PAQ)
timeFrame: After enrollment and follow-up at month 2
measure: Peripheral Artery Questionnaire (PAQ)
timeFrame: After enrollment and follow-up at month 6
measure: Peripheral Artery Questionnaire (PAQ)
timeFrame: After enrollment and follow-up at month 12
Secondary outcomes:
measure: Major adverse limb events (MALE)
timeFrame: 6 months after enrollment
measure: Major adverse limb events (MALE)
timeFrame: 12 months after enrollment
measure: Major adverse limb events (MALE)
timeFrame: 5 years after enrollment
measure: Amputation Free Survival (AFS)
timeFrame: 6 months after enrollment
measure: Amputation Free Survival (AFS)
timeFrame: 12 months after enrollment
measure: Amputation Free Survival (AFS)
timeFrame: 5 years after enrollment
measure: Mortality - Death
timeFrame: 6 months after enrollment
measure: Mortality - Death
timeFrame: 12 months after enrollment
measure: Mortality - Death
timeFrame: 5 years after enrollment
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Health
state: Connecticut
Study officials:
affiliation: Yale University
name: Kim Smolderen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scierka LE, Mena-Hurtado C, Shishehbor MH, Spertus JA, Nagpal S, Babrowski T, Bunte MC, Politano A, Humphries M, Chung J, Kirksey L, Alabi O, Soukas P, Parikh S, Faizer R, Fitridge R, Provance J, Romain G, McMillan N, Stone N, Scott K, Fuss C, Pacheco CM, Gosch K, Harper-Brooks A, Smolderen KG; SCOPE-CLI Academic Research Consortium. The shifting care and outcomes for patients with endangered limbs - Critical limb ischemia (SCOPE-CLI) registry overview of study design and rationale. Int J Cardiol Heart Vasc. 2022 Feb 12;39:100971. doi: 10.1016/j.ijcha.2022.100971. eCollection 2022 Apr.