Clinical trial NCT03171259: SCOPE CLI (Shifting Care and Outcomes for Patients With Endangered Limbs - Critical Limb Ischemia)
Official title: SCOPE CLI (Shifting Care and Outcomes for Patients With Endangered Limbs- Critical Limb Ischemia)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Limb Ischemia
Lead sponsor: Saint Luke's Health System
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2017-05-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: CLI-specific health status
timeFrame: 12 months
Secondary outcomes:
measure: Freedom from major amputation or major reintervention
timeFrame: 12 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Cleveland
country: United States
facility: University Hospitals Cleveland
state: Ohio
Study officials:
affiliation: University of Missouri Kansas City; Saint Luke's Hospital
name: Kim Smolderen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.