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

NCT03171259 | Completed

• 1 other identifier: 17-054
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

Given the importance of understanding CLI patients' outcomes and existing gaps in knowledge, there is a pressing need to collect observational data on treatment patterns, adherence to performance measures, and outcomes that are relevant to patients and clinicians. To address this need, the current study will pilot test the research infrastructure and data elements needed to build a larger, national study collecting of the CLI population. It will also provide much-needed preliminary information to identify areas of action that can be targeted in quality improvement programs for this population. Most importantly, it will provide data on health status outcomes in patients with CLI, as a function of individual patient characteristics (demographics, socio-economic and clinical background) and the treatments that patients have undergone. The PORTRAIT-CLI study will also be well equipped to identify potential disparities in the provision of care and patients' outcomes as a function of patient's characteristics.

Conditions

Critical Limb Ischemia

Outcome Measures

Primary Outcomes (1)

• CLI-specific health status

  Peripheral Artery Questionnaire-CLI version

  12 months

Secondary Outcomes (1)

• Freedom from major amputation or major reintervention

  12 months

Interventions

care as usual OTHER

The investigators will be following patients with critical limb ischemia and documenting the usual care that the participants receive.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Project coordinators at each recruitment site will have direct access to the PAD clinic schedules and will be prospectively screening from that list. A screening form with limited demographic information will be completed for all patients with a diagnosis of CLI supported by any of the following hemodynamic parameters (assessed pre-procedurally): Ankle pressure lower than 70 mmHg; Toe pressure lower than 50 mmHg or evidence of ischemia by transcutaneous oxygen measurement (tcpO2) \<40 or a skin perfusion pressure (SPP) \<40 or angiographic evidence of significant vascular disease.

You may qualify if:

• All race/ethnicity categories, English or Spanish speaking, men and women
• Age ≥18 years
• Patients presenting with Rutherford Classification 4 (ischemic rest pain), or Rutherford Classification 5 (minor tissue loss: non-healing ulcer, focal gangrene with diffuse pedal ischemia), or Rutherford Classification 6 (major tissue loss: extending above transmetatarsal level, functional foot no longer salvageable) at specialty clinics will prospectively be screened, regardless of whether the patient undergoes endovascular, bypass, amputation, and/or medical therapy.
• Diagnosis is supported by any of the following hemodynamic parameters (assessed pre- procedurally): Ankle pressure lower than 70 mmHg; Toe pressure lower than 50 mmHg or evidence of ischemia by transcutaneous oxygen measurement (tcpO2) \<40 or a skin perfusion pressure (SPP) \<40 or angiographic evidence of significant vascular disease

You may not qualify if:

• No other prior surgical or vascular interventions within 2 weeks before and/or planned 30 days after the enrollment
• Acute limb ischemia
• Unable to provide written informed consent
• Currently a prisoner

Sponsors & Collaborators

• Saint Luke's Health System: lead
• Boston Scientific Corporation: collaborator

Study Sites (2)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

University Hospitals Cleveland

Cleveland, Ohio, 44106, United States

Location

Related Publications (3)

• Bradbury AW, Adam DJ, Bell J, Forbes JF, Fowkes FG, Gillespie I, Ruckley CV, Raab GM; BASIL trial Participants. Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: Analysis of amputation free and overall survival by treatment received. J Vasc Surg. 2010 May;51(5 Suppl):18S-31S. doi: 10.1016/j.jvs.2010.01.074.

  PMID: 20435259 BACKGROUND

• Spertus J, Jones P, Poler S, Rocha-Singh K. The peripheral artery questionnaire: a new disease-specific health status measure for patients with peripheral arterial disease. Am Heart J. 2004 Feb;147(2):301-8. doi: 10.1016/j.ahj.2003.08.001.

  PMID: 14760329 BACKGROUND

• Adam DJ, Beard JD, Cleveland T, Bell J, Bradbury AW, Forbes JF, Fowkes FG, Gillepsie I, Ruckley CV, Raab G, Storkey H; BASIL trial participants. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet. 2005 Dec 3;366(9501):1925-34. doi: 10.1016/S0140-6736(05)67704-5.

  PMID: 16325694 RESULT

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Kim Smolderen, PhD

  University of Missouri Kansas City; Saint Luke's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 31, 2017
• Study Start: January 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: May 24, 2024

Record last verified: 2024-05

Locations

US (2)