Clinical trial NCT05818046: Analysis of Arterial Waveforms and Oxygen Pressure During Supervised Exercise for Peripheral Artery Disease
Official title: Analysis of Arterial Waveforms and Oxygen Pressure During Supervised Exercise for Peripheral Artery Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Peripheral Arterial Disease
Supervised exercise therapy
arterial waveform
transcutaneous oxygen pressure
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The goal of this observational study is to assess the evolution of oxygen pressure and arterial waveform during supervised exercise therapy in patients with peripheral arterial disease. The main questions it aims to answer are:

* can a significant increase in oxygen pressure be observed at 3 weeks?
* can a significant increase of oxygen pressure or arterial waveform be observed at 3, 6 or 9 weeks?

Detailed description: Peripheral arterial disease (PAD) is a frequent pathology that affects more than 200 million people worldwide, more than 800,000 in France, and is mainly of atheromatous origin. The prevalence of this disease in France is estimated at 11% in people over 40 years of age, with an annual additional cost of €11,000 per patient. Supervised exercise therapy (SET) is the first-line treatment for intermittent claudication PAD for at least 3 months, although 15-20% of patients will not benefit from this therapy. Ankle-Brachial Index, the main diagnostic and monitoring tool for PAD, is not altered during SET. Transcutaneous oximetry (TcPO2) has been used for many years in the diagnosis of chronic permanent ischaemia, in the choice of amputation level and more recently in the diagnosis of proximal PAD.

No studies have investigated the evolution and predictive value of exercise TcPO2 in this context of SET. The assessment of arterial Doppler waveform using an objective classification has also never been performed in the specific context of SET. .

The goal of this observational study is to assess the evolution of oxygen pressure and arterial waveform during supervised exercise therapy in patients with peripheral arterial disease. The main questions it aims to answer are:

* can a significant increase in oxygen pressure be observed at 3 weeks?
* can a significant increase of oxygen pressure or arterial waveform be observed at 3, 6 or 9 weeks.

The perspective is to predict the effectiveness of SET in terms of maximum walking distance.

Eligibility criteria: Inclusion Criteria:

* PAD with intermittent claudication
* SET prescribed
* ABI \< 0.9
* Beneficiary of French health care insurance

Exclusion Criteria:

* PAD with rest ischemia
* Chronic respiratory failure
* Acute decompensated disease
* Lower limb prosthesis
* Pregnant women and breastfeeding mothers
* Place of residence more than 100 km from Caen University Hospital

Primary outcomes:
measure: Evolution of oximetry at 3 week from baseline
timeFrame: at 3 weeks
Secondary outcomes:
measure: Evolution of doppler waveform at 3 week from baseline
timeFrame: at 3 weeks
measure: Evolution of doppler waveform at 6 week from baseline
timeFrame: 6 weeks
measure: Evolution of doppler waveform at 9 week from baseline
timeFrame: 9 weeks
measure: Evolution of doppler waveform at 12 week from baseline
timeFrame: 12 weeks
measure: Evolution of oximetry at 6 week from baseline
timeFrame: at 6 weeks
measure: Evolution of oximetry at 9 week from baseline
timeFrame: at 9 weeks
measure: Evolution of oximetry at 12 week from baseline
timeFrame: at 12 weeks
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU Caen Normandie
state: Normandie
Study officials:
References:
citation: STRANDNESS DE Jr, BELL JW. AN EVALUATION OF THE HEMODYNAMIC RESPONSE OF THE CLAUDICATING EXTREMITY TO EXERCISE. Surg Gynecol Obstet. 1964 Dec;119:1237-42. No abstract available.
citation: Gardner AW. Reliability of transcutaneous oximeter electrode heating power during exercise in patients with intermittent claudication. Angiology. 1997 Mar;48(3):229-35. doi: 10.1177/000331979704800305.
citation: Spronk S, den Hoed PT, de Jonge LC, van Dijk LC, Pattynama PM. Value of the duplex waveform at the common femoral artery for diagnosing obstructive aortoiliac disease. J Vasc Surg. 2005 Aug;42(2):236-42; discussion 242. doi: 10.1016/j.jvs.2005.04.048.
citation: Mahe G, Boulon C, Desormais I, Lacroix P, Bressollette L, Guilmot JL, Le Hello C, Sevestre MA, Pernod G, Constans J, Boissier C, Bura-Riviere A. Statement for Doppler waveforms analysis. Vasa. 2017 Aug;46(5):337-345. doi: 10.1024/0301-1526/a000638. Epub 2017 May 19.
citation: Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE, Fleisher LA, Fowkes FG, Hamburg NM, Kinlay S, Lookstein R, Misra S, Mureebe L, Olin JW, Patel RA, Regensteiner JG, Schanzer A, Shishehbor MH, Stewart KJ, Treat-Jacobson D, Walsh ME. 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017 Mar 21;135(12):e726-e779. doi: 10.1161/CIR.0000000000000471. Epub 2016 Nov 13.
citation: Aboyans V, Ricco JB, Bartelink MEL, Bjorck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylor AR, Roffi M, Rother J, Sprynger M, Tendera M, Tepe G, Venermo M, Vlachopoulos C, Desormais I; ESC Scientific Document Group. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European Stroke Organization (ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J. 2018 Mar 1;39(9):763-816. doi: 10.1093/eurheartj/ehx095. No abstract available.