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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease

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.

• Study Type: Observational
• Enrollment (Estimated): 816

Contacts and Locations

• Study Contact: Name: Avis Harper Brooks, MA; Phone Number: 203-737-7673; Email: avis.harperbrooks@yale.edu
• Study Contact Backup: Name: Carlos Mena-Hurtado, MD; Phone Number: 203-737 7673; Email: carlos.mena-hurtado@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale New Haven Health
      • Contact: Carlos Mena-Hurtado, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Baylor College of Medicine; University of Chicago; Columbia University; Brown University; Janssen Scientific Affairs, LLC; The Cleveland Clinic; Emory University; University of Southern California; University of California, Davis; Oregon Health and Science University; University of Minnesota; Abbott; Saint Luke's Health System
• Investigators: Principal Investigator: Kim Smolderen, PhD, Yale University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2021
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: January 4, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 2000028963; 000 (Other Identifier: CTGTY)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No