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

Sponsor

Yale University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04710563

Collaborator

University of Chicago (Other), Oregon Health and Science University (Other), University of California, Davis (Other), University of Southern California (Other), Baylor College of Medicine (Other), The Cleveland Clinic (Other), Emory University (Other), Brown University (Other), Columbia University (Other), University of Minnesota (Other), Saint Luke's Health System (Other)

816

Enrollment

Location

Anticipated Duration (Months)

12.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

816 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 11, 2021

Anticipated Primary Completion Date :

Dec 11, 2022

Anticipated Study Completion Date :

Dec 11, 2026

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Major adverse limb events (MALE) [6 months after enrollment]
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)
Major adverse limb events (MALE) [12 months after enrollment]
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)
Major adverse limb events (MALE) [5 years after enrollment]
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)
Amputation Free Survival (AFS) [6 months after enrollment]
AFS will be a measure of number of patients "free from death or above ankle amputation"
Amputation Free Survival (AFS) [12 months after enrollment]
AFS will be a measure of number of patients "free from death or above ankle amputation"
Amputation Free Survival (AFS) [5 years after enrollment]
AFS will be a measure of number of patients "free from death or above ankle amputation"
Mortality - Death [6 months after enrollment]
Vital status obtained from either medical records or social security death index will be assessed to account for number of patients who died
Mortality - Death [12 months after enrollment]
Vital status obtained from either medical records or social security death index will be assessed to account for number of patients who died
Mortality - Death [5 years after enrollment]
Vital status obtained from either medical records or social security death index will be assessed to account for number of patients who died

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale New Haven Health	New Haven	Connecticut	United States	06510

Investigators

Principal Investigator: Kim Smolderen, PhD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yale University

ClinicalTrials.gov Identifier:

NCT04710563

Other Study ID Numbers:

2000028963

First Posted:

Jan 14, 2021

Last Update Posted:

Aug 30, 2021

Last Verified:

Aug 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Peripheral Arterial Disease

Peripheral Vascular Diseases

Study Results

No Results Posted as of Aug 30, 2021