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Investigators conduct a monocentric pilot study with the objective to determine the hemodynamic parameter of fluorescence angiography (slope, amplitude, saturation time ) best correlated with toe pressure in patients with suspicion of critical limb ischemia.
Critical limb ischemia, defined as the presence of chronic ischemic rest pain, ulcers or gangrene attributable to objectively proven arterial occlusive disease, is associated with the appalling prospect that approximately 30% will lose their leg and 25% will die at one year. Despite the progress of therapeutics these statistics haven't changed. Critical limb ischemia is a clinical diagnosis but should be supported by objective tests. None of theses tests (toe blood pressure (TBP), transcutaneous oxygen pressure (TcPO2) and skin perfusion pressure (SPP)) have proven to be enough specific or sensitive, more so they are time consuming, can be subject to several artifacts and may be in some cases discordant making diagnosis difficult. Fluorescence angiography has long been used in ophthalmology for the evaluation of the microcirculation of the retina. Infracyanine remains within the intravascular space allowing the visualization of the vasculature to a depth of 10 mm. With the Fluobeam system, images to a maximal width of 20 cm can be obtained therefore allowing the evaluation of the tissue perfusion of the entire foot.
Method: Fluorescence angiography is performed in the laboratory in the same time as TCPO2, TP and SPP. Infracyanine is injected in an antecubital vein and visualization and signal acquisition carried out using a specific camera device (Fluoptic SAS, France) producing the time course of hemodynamic parameters (slope, amplitude, saturation time).
30patients will be evaluated with correlation between data obtained by fluorescence angiography and too blood pressure
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with suspicion of CLI | Experimental | patients presenting with peripheral artery disease and suspicion of critical limb ischemia as assessed by TASK II consensus 30 patients will be enrolled and will benefit of measures of TcPO2, too systolic blood pressure and skin perfusion pressure and in the same time angiography with fluorescence (Indocyanine grey 0.05 mg/kg by intravenous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluorescence angiography | Device | Injection of indocyanine grey in an antecubital vein at the posology of 0.05 mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of parameters of fluorescence on time intensity curve ( saturation time (s) with toe pressure (mm hg) assessed by laser doppler | instantaneous, at the time the exam is performed | |
| Correlation of parameters of fluorescence on time intensity curve ( amplitude (UA) with toe pressure (mm hg) assessed by laser doppler | instantaneous, at the time the exam is performed | |
| Correlation of parameters of fluorescence on time intensity curve ( slope) with toe pressure (mm hg) assessed by laser doppler | instantaneous, at the time the exam is performed |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of parameters of fluorescence on time intensity curve ( saturation time (s) with transcutaneous cutaneous pressure of oxygen (mm Hg) | instantaneous, at the time the exam is performed | |
| Correlation of parameters of fluorescence on time intensity curve ( amplitude (UA) with transcutaneous cutaneous pressure of oxygen (mm Hg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| christophe seinturier, MD | Contact | 0033476765547 | cseinturier@chu-grenoble.fr |
| Name | Affiliation | Role |
|---|---|---|
| christophe seinturier, MD | CHU Grenoble france | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU grenoble | Recruiting | Grenoble | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22172472 | Background | Becker F, Robert-Ebadi H, Ricco JB, Setacci C, Cao P, de Donato G, Eckstein HH, De Rango P, Diehm N, Schmidli J, Teraa M, Moll FL, Dick F, Davies AH, Lepantalo M, Apelqvist J. Chapter I: Definitions, epidemiology, clinical presentation and prognosis. Eur J Vasc Endovasc Surg. 2011 Dec;42 Suppl 2:S4-12. doi: 10.1016/S1078-5884(11)60009-9. | |
| 3898252 |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005451 | Fluorescein Angiography |
| ID | Term |
|---|---|
| D000792 | Angiography |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| instantaneous, at the time the exam is performed |
| Correlation of parameters of fluorescence on time intensity curve (slope) with transcutaneous cutaneous pressure of oxygen (mm Hg) | instantaneous, at the time the exam is performed |
| Bloch C, Richard JL. [Risk factors for atherosclerotic diseases in the Prospective Parisian Study I. Comparison with foreign studies]. Rev Epidemiol Sante Publique. 1985;33(2):108-20. French. |
| 23352361 | Background | Braun JD, Trinidad-Hernandez M, Perry D, Armstrong DG, Mills JL Sr. Early quantitative evaluation of indocyanine green angiography in patients with critical limb ischemia. J Vasc Surg. 2013 May;57(5):1213-8. doi: 10.1016/j.jvs.2012.10.113. Epub 2013 Jan 24. |
| 25214365 | Background | Chung J, Modrall JG, Valentine RJ. The need for improved risk stratification in chronic critical limb ischemia. J Vasc Surg. 2014 Dec;60(6):1677-85. doi: 10.1016/j.jvs.2014.07.104. Epub 2014 Sep 8. |
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| 25282695 | Background | Cull DL, Manos G, Hartley MC, Taylor SM, Langan EM, Eidt JF, Johnson BL. An early validation of the Society for Vascular Surgery lower extremity threatened limb classification system. J Vasc Surg. 2014 Dec;60(6):1535-41. doi: 10.1016/j.jvs.2014.08.107. Epub 2014 Oct 3. |
| 25439329 | Background | Elsayed S, Clavijo LC. Critical limb ischemia. Cardiol Clin. 2015 Feb;33(1):37-47. doi: 10.1016/j.ccl.2014.09.008. |
| 23972435 | Background | Terasaki H, Inoue Y, Sugano N, Jibiki M, Kudo T, Lepantalo M, Venermo M. A quantitative method for evaluating local perfusion using indocyanine green fluorescence imaging. Ann Vasc Surg. 2013 Nov;27(8):1154-61. doi: 10.1016/j.avsg.2013.02.011. Epub 2013 Aug 20. |
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| 3965550 | Background | Kannel WB, McGee DL. Update on some epidemiologic features of intermittent claudication: the Framingham Study. J Am Geriatr Soc. 1985 Jan;33(1):13-8. doi: 10.1111/j.1532-5415.1985.tb02853.x. |
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| 17140820 | Background | Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group; Bell K, Caporusso J, Durand-Zaleski I, Komori K, Lammer J, Liapis C, Novo S, Razavi M, Robbs J, Schaper N, Shigematsu H, Sapoval M, White C, White J, Clement D, Creager M, Jaff M, Mohler E 3rd, Rutherford RB, Sheehan P, Sillesen H, Rosenfield K. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl 1:S1-75. doi: 10.1016/j.ejvs.2006.09.024. Epub 2006 Nov 29. No abstract available. |
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003941 | Diagnostic Techniques, Ophthalmological |