Clinical trial NCT06014242: Peripheral Microvascular Resistance as a Predictor for Limb Salvage
Official title: Peripheral Microvascular Resistance as a Predictor for Limb Salvage in Post-Intervention Critical Limb Ischemia Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Microvascular disease
Microvascular Resistance
Limb Salvage
Peripheral Arterial Disease
critical limb ischemia
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2023-08-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Salvaging a threatened limb is the key therapeutic objective for patients with critical limb ischemia, and the achievement of limb salvage is an independent predictor of patient morbidity and mortality. Despite successful primary endovascular or surgical intervention, the corresponding symptoms of rest pain and/or non-healing ulceration in some patients may continue, and amputation in these patients is unavoidable. It is hypothesized that the functional integrity of the peripheral vascular microcirculation may be impaired in these patients. However, there are currently no techniques that allow direct quantification and visualization of the microcirculation due to the micro-vessel invisibility under angiography.

In the coronary circulation, coronary flow reserve (CFR) indicates the capacity for maximal hyperemic blood flow and reveals impaired coronary microvascular function. Studies have shown the clinical significance of measuring microvascular resistance to predict myocardial salvage after myocardial infarction. The study will explore whether this concept of coronary flow reserve can be applied peripherally to patients with critical limb ischemia in order to determine whether measuring peripheral vascular flow reserve can determine the integrity of the microcirculation to predict limb salvage after endovascular intervention.


Eligibility criteria: Inclusion Criteria:

* Chronic critical limb ischemia (Rutherford 4-6).
* Age ≥18 years
* Ability and willingness to sign the IRB approved Informed Consent form

Exclusion Criteria:

* Non-reconstructable chronic total occlusive disease of the proximal inflow vessels that would make flow reserve measurements impossible.
* Non-salvageable lower extremity due to infection or overwhelming per-existing tissue loss (most critical Rutherford 6 patients).
* Inability to understand the study or a history of non-compliance with medical advice;
* History of any cognitive or mental health status that would interfere with study participation;
* Currently enrolled in any pre-approval investigational study.
* Female subjects who are pregnant or nursing or planning to become pregnant within the study period;
* Known sensitivity to contrast media, which can't be adequately pre-medicated;
* Expected life span less than 6 months.
* Unable to read/understand/sign the English Language consent form

Primary outcomes:
measure: Efficacy of the peripheral flow reserve
timeFrame: 6 months post-endovascular intervention
Secondary outcomes:
measure: Symptom resolution - Ulcer healing (1m)
timeFrame: 1 month post-endovascular intervention
measure: Symptom resolution - Ulcer healing (6m)
timeFrame: 6 months post-endovascular intervention
measure: Number of patients with Symptom resolution - Pain (1m)
timeFrame: 1 month post-endovascular intervention
measure: Number of patients with Symptom resolution - Pain (6m)
timeFrame: 6 months post-endovascular intervention
measure: Ankle-brachial index (ABI) (1m)
timeFrame: 1 month post-endovascular intervention
measure: Ankle-brachial index (ABI) (6m)
timeFrame: 6 months post-endovascular intervention
measure: Toe-brachial index (TBI) (1m)
timeFrame: 1 month post-endovascular intervention
measure: Toe-brachial index (TBI) (6m)
timeFrame: 6 months post-endovascular intervention
measure: Rutherford classification (1m)
timeFrame: 1 month post-endovascular intervention
measure: Rutherford classification (6m)
timeFrame: 6 months post-endovascular intervention
measure: Transcutaneous oxygen partial pressure (TcPO2) (1m)
timeFrame: 1 month post-endovascular intervention
measure: Transcutaneous oxygen partial pressure (TcPO2) (6m)
timeFrame: 6 months post-endovascular intervention
measure: Target lesion revascularization (1m)
timeFrame: At 1 month post-endovascular intervention
measure: Target lesion revascularization (6m)
timeFrame: At 6 month post-endovascular intervention
Other outcomes:
Locations:
Study officials:
affiliation: Hackensack Meridian Health
name: David O'Connor, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McGinn, A.L., White, C.W. and Wilson, R.F., 1990. Interstudy variability of coronary flow reserve. Influence of heart rate, arterial pressure, and ventricular preload. Circulation, 81(4), pp.1319-1330. Nahser Jr, P.J., Brown, R.E., Oskarsson, H., Winniford, M.D. and Rossen, J.D., 1995. Maximal coronary flow reserve and metabolic coronary vasodilation in patients with diabetes mellitus. Circulation, 91(3), pp.635-640. Payne, A.R., Berry, C., Doolin, O., McEntegart, M., Petrie, M.C., Lindsay, M.M., Hood, S., Carrick, D., Tzemos, N., Weale, P. and McComb, C., 2012. Microvascular resistance predicts myocardial salvage and infarct characteristics in ST-elevation myocardial infarction. Journal of the American Heart Association, 1(4), p.e002246. Camici, P.G., d'Amati, G. and Rimoldi, O., 2015. Coronary microvascular dysfunction: mechanisms and functional assessment. Nature Reviews Cardiology, 12(1), p.48.
citation: Fukunaga M, Fujii K, Kawasaki D, Nishimura M, Horimatsu T, Saita T, Miki K, Tamaru H, Imanaka T, Naito Y, Masuyama T. Vascular flow reserve immediately after infrapopliteal intervention as a predictor of wound healing in patients with foot tissue loss. Circ Cardiovasc Interv. 2015 Jun;8(6):e002412. doi: 10.1161/CIRCINTERVENTIONS.115.002412.
citation: Crea, F., Lanza, G.A. and Camici, P.G., 2014. Mechanisms of coronary microvascular dysfunction. In Coronary Microvascular Dysfunction (pp. 31-47). Springer, Milano.
citation: Pijls NH, De Bruyne B, Smith L, Aarnoudse W, Barbato E, Bartunek J, Bech GJ, Van De Vosse F. Coronary thermodilution to assess flow reserve: validation in humans. Circulation. 2002 May 28;105(21):2482-6. doi: 10.1161/01.cir.0000017199.09457.3d.
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