Study Results
Results pending
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Basic Information
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Recruitment Status
TERMINATED
Total Enrollment
60 participants
Study Classification
OBSERVATIONAL
Study Start Date
2022-08-24
Study Completion Date
2023-12-01
Brief Summary
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The research objectives of this project are to increase the understanding of pathophysiology and performance limitations related to sport-related flow limitation in the iliac artery (FLIA) using non-invasive measurement of muscle oxygenation at the working muscles of the leg and mechanical power output recorded during cycling exercise. Skeletal muscle oxygenation measured with Near-Infrared Spectroscopy (NIRS) is growing more accessible for use by coaches, teams, and individual athletes for use in performance testing. Describing how muscle oxygenation profiles in endurance athletes diagnosed with FLIA differ in comparison with healthy athletes may allow the use of this non-invasive, accessible measurement device for the screening of athletes at risk of developing FLIA.
The relevance of this work is that FLIA imposes risk of irreversible injury to the main artery of the leg in endurance athletes, limiting their ability to participate in exercise, with further consequences for health, fitness, and quality of life. Currently, the early course of this progressive condition is poorly understood, as early detection is difficult and hence appropriate treatment is often delayed. If impairment becomes severe, often more invasive (and risky) treatment is necessary. Earlier detection and monitoring of FLIA may allow for improved patient management and outcomes.
The design of this experiment will compare a patient group of trained cyclists diagnosed with FLIA, to healthy control subjects including cyclists of a similar fitness level without signs of FLIA. Both groups will perform an incremental ramp cycling test and an intermittent multi-stage cycling exercise test. Incremental ramp cycling testing is used as part of clinical diagnosis of FLIA, as well as performance (eg. VO2max) testing of healthy athletes. Multi-stage exercise protocols are also often used for performance testing of endurance athletes and allows for observation of (path)physiological responses during submaximal work stages. Outcome measures of muscle oxygenation kinetics with NIRS and cycling power will be analysed and compared between patients and healthy subjects.
The relevance of this work is that FLIA imposes risk of irreversible injury to the main artery of the leg in endurance athletes, limiting their ability to participate in exercise, with further consequences for health, fitness, and quality of life. Currently, the early course of this progressive condition is poorly understood, as early detection is difficult and hence appropriate treatment is often delayed. If impairment becomes severe, often more invasive (and risky) treatment is necessary. Earlier detection and monitoring of FLIA may allow for improved patient management and outcomes.
The design of this experiment will compare a patient group of trained cyclists diagnosed with FLIA, to healthy control subjects including cyclists of a similar fitness level without signs of FLIA. Both groups will perform an incremental ramp cycling test and an intermittent multi-stage cycling exercise test. Incremental ramp cycling testing is used as part of clinical diagnosis of FLIA, as well as performance (eg. VO2max) testing of healthy athletes. Multi-stage exercise protocols are also often used for performance testing of endurance athletes and allows for observation of (path)physiological responses during submaximal work stages. Outcome measures of muscle oxygenation kinetics with NIRS and cycling power will be analysed and compared between patients and healthy subjects.
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Detailed Description
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A professional cyclist covers approximately 25,000 km a year and flexes the hip 8,000,000 times in a year, while leg blood flow is in the range of 10-15 litres per minute. This poses a substantial hemodynamic load on the iliac artery. As a result, a proportion of endurance athletes develop a limitation in leg circulation due to arterial narrowing in this iliac artery. An early 'Lancet' study of the department of Sports Medicine of Máxima Medical Centre (MMC) found that 20% of professional cyclists were suffering from such a sport-related Flow Limitation in the Iliac Artery (FLIA) necessitating treatment. The incidence in recreational cyclists is unknown, but with 849,000 recreational cyclists in the Netherlands cycling over 3,000 km a year with an impressive 1,000,000 hip flexions, many of them travel similar distances as a professional cyclist, incurring similar risks for developing FLIA. If untreated, FLIA may have a pronounced impact on quality of life. Professional athletes may have to end their careers prematurely. In a substantial subset of cyclists, abnormalities may even lead to complete occlusion and/or thrombosis, with severe symptoms in daily life.
Clinical experience suggests that early detection and treatment leads to better outcomes. If diagnosed at a late stage, conservative management including changes in training behaviours and body position, or least-invasive surgical repair options will no longer suffice. The only options remaining would be to cease participation in the provocative activities altogether, or to undergo extensive and risky reconstructive vascular surgery. Understanding the early pathogenesis in order to improve detection is thus of paramount importance. Unfortunately, early detection is often missed due to the non-specific presentation of symptoms and the high level of specialisation required for clinical evaluation. There is a wide range of differential diagnoses that could contribute to the non-specific symptoms observed in the early stages of FLIA, including common musculoskeletal and tendinous injuries, mechanical or neurogenic pain referred from the low back or SI joint, hip acetabular labral tear, chronic exertional compartment syndrome, or fibromuscular dysplasia.8 Currently available diagnostic evaluations can have low sensitivity for an athletic population.
There is no single gold-standard evaluation for diagnosing FLIA. The current consensus suggests that the best single functional test is a provocative maximal exercise test on a cycle ergometer, followed by measuring blood pressure at the ankle and brachial arteries (ankle-brachial blood pressure index; ABI) in a competitive posture. In the rare case that the problem is unilateral, the sensitivity is 73%. If the problem is bilateral, the sensitivity is only 43%. Imaging techniques, including echo-Doppler examination, magnetic resonance angiogram (MRA), and computed tomography (CT) scan are more sensitive, but they are more expensive, less accessible, and not part of primary care evaluation, instead being typically reserved for investigation of more severe or complex presentations, and to guide surgical repair.
Near-infrared Spectroscopy (NIRS) is an innovative technique that measures relative oxygenation in the muscle, as the balance of oxygenated and deoxygenated haemoglobin and myoglobin. Impaired arterial leg circulation, such as observed in peripheral vascular disease (PVD) has been shown to produce a drop in oxygen saturation of skeletal muscle tissue relative to workload or exercise performance, and delays in reoxygenation kinetics after exercise and ischemic vascular occlusion tests (VOT). Consequently, NIRS may be able to detect alterations in oxygenation that are associated with the level of arterial insufficiency. We recently reported proof of concept studies regarding the potential diagnostic role of both power output and NIRS in patients with diagnosed sport-related FLIA.
Complaints reported in the early stages of FLIA are powerlessness and pain in the leg muscles when cycling near maximal exertion, which rapidly disappear with rest. Traditionally, incremental ramp cycling exercise to maximal exercise tolerance has been used as a provocative functional test, after which clinical outcome measures including ABI are tested. As the condition progresses however, symptoms can occur earlier during exercise at a lower intensity and take longer to resolve during recovery. Multi-stage exercise protocols are commonly used to understand metabolic responses related to submaximal exercise intensity. Therefore, a progressive multi-stage cycling protocol with brief recovery intervals between work intervals will be introduced. This protocol is designed to allow for multiple opportunities to evaluate work and recovery responses in an intensity-dependent manner. Subjective symptoms, performance impairments (including limitations to cycling power output) and muscle oxygenation kinetic delays will be evaluated across submaximal workloads including after maximal intensity.
Understanding the onset of symptoms and objective signs of flow limitation with progressive exercise intensity will improve understanding of severity and progression of this condition. These outcome measures will be compared to healthy subjects, in order to develop normative values related to healthy performance, compared to pathological impairment. The use of a common multi-stage performance assessment protocol will improve the applicability of using this approach for screening and early detection of FLIA outside of a specialised vascular clinic.
It has been suggested that altered vascular function and structure may contribute to the appearance of symptoms in patients in which obvious stenosis or intraluminal disease is not apparent on imaging. In addition to standard clinical evaluation of the aortoiliac tract with echo-Doppler ultrasound, vascular flow velocity will be recorded for later offline analysis of pulse wave velocity as a measurement of arterial stiffness.
Clinical experience suggests that early detection and treatment leads to better outcomes. If diagnosed at a late stage, conservative management including changes in training behaviours and body position, or least-invasive surgical repair options will no longer suffice. The only options remaining would be to cease participation in the provocative activities altogether, or to undergo extensive and risky reconstructive vascular surgery. Understanding the early pathogenesis in order to improve detection is thus of paramount importance. Unfortunately, early detection is often missed due to the non-specific presentation of symptoms and the high level of specialisation required for clinical evaluation. There is a wide range of differential diagnoses that could contribute to the non-specific symptoms observed in the early stages of FLIA, including common musculoskeletal and tendinous injuries, mechanical or neurogenic pain referred from the low back or SI joint, hip acetabular labral tear, chronic exertional compartment syndrome, or fibromuscular dysplasia.8 Currently available diagnostic evaluations can have low sensitivity for an athletic population.
There is no single gold-standard evaluation for diagnosing FLIA. The current consensus suggests that the best single functional test is a provocative maximal exercise test on a cycle ergometer, followed by measuring blood pressure at the ankle and brachial arteries (ankle-brachial blood pressure index; ABI) in a competitive posture. In the rare case that the problem is unilateral, the sensitivity is 73%. If the problem is bilateral, the sensitivity is only 43%. Imaging techniques, including echo-Doppler examination, magnetic resonance angiogram (MRA), and computed tomography (CT) scan are more sensitive, but they are more expensive, less accessible, and not part of primary care evaluation, instead being typically reserved for investigation of more severe or complex presentations, and to guide surgical repair.
Near-infrared Spectroscopy (NIRS) is an innovative technique that measures relative oxygenation in the muscle, as the balance of oxygenated and deoxygenated haemoglobin and myoglobin. Impaired arterial leg circulation, such as observed in peripheral vascular disease (PVD) has been shown to produce a drop in oxygen saturation of skeletal muscle tissue relative to workload or exercise performance, and delays in reoxygenation kinetics after exercise and ischemic vascular occlusion tests (VOT). Consequently, NIRS may be able to detect alterations in oxygenation that are associated with the level of arterial insufficiency. We recently reported proof of concept studies regarding the potential diagnostic role of both power output and NIRS in patients with diagnosed sport-related FLIA.
Complaints reported in the early stages of FLIA are powerlessness and pain in the leg muscles when cycling near maximal exertion, which rapidly disappear with rest. Traditionally, incremental ramp cycling exercise to maximal exercise tolerance has been used as a provocative functional test, after which clinical outcome measures including ABI are tested. As the condition progresses however, symptoms can occur earlier during exercise at a lower intensity and take longer to resolve during recovery. Multi-stage exercise protocols are commonly used to understand metabolic responses related to submaximal exercise intensity. Therefore, a progressive multi-stage cycling protocol with brief recovery intervals between work intervals will be introduced. This protocol is designed to allow for multiple opportunities to evaluate work and recovery responses in an intensity-dependent manner. Subjective symptoms, performance impairments (including limitations to cycling power output) and muscle oxygenation kinetic delays will be evaluated across submaximal workloads including after maximal intensity.
Understanding the onset of symptoms and objective signs of flow limitation with progressive exercise intensity will improve understanding of severity and progression of this condition. These outcome measures will be compared to healthy subjects, in order to develop normative values related to healthy performance, compared to pathological impairment. The use of a common multi-stage performance assessment protocol will improve the applicability of using this approach for screening and early detection of FLIA outside of a specialised vascular clinic.
It has been suggested that altered vascular function and structure may contribute to the appearance of symptoms in patients in which obvious stenosis or intraluminal disease is not apparent on imaging. In addition to standard clinical evaluation of the aortoiliac tract with echo-Doppler ultrasound, vascular flow velocity will be recorded for later offline analysis of pulse wave velocity as a measurement of arterial stiffness.
Conditions
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Near-Infrared Spectroscopy
Iliac Artery Stenosis
Iliac Artery Disease
Iliac Artery Occlusion
Study Design
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Observational Model Type
CASE_CONTROL
Study Time Perspective
PROSPECTIVE
Study Groups
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Healthy subjects
Subjects without FLIA
Cycling test
Intervention Type
OTHER
RAMP and MULTI-STAGE test
Occlusion tests
Intervention Type
OTHER
Occlusion test before and after exercise
NIRS during cycling
Intervention Type
DEVICE
NIRS devices measuring oxygenation during exercise
CPET
Intervention Type
DEVICE
Cardiopulmonary exercise testing (heart rate, pulmonary gas exchange) during exercise
Echo-Doppler examination
Intervention Type
DEVICE
Peak systolic velocity and vascular stiffness measurements in the iliac-aortic tract
Patient subjects
Subjects with FLIA
Cycling test
Intervention Type
OTHER
RAMP and MULTI-STAGE test
Occlusion tests
Intervention Type
OTHER
Occlusion test before and after exercise
NIRS during cycling
Intervention Type
DEVICE
NIRS devices measuring oxygenation during exercise
CPET
Intervention Type
DEVICE
Cardiopulmonary exercise testing (heart rate, pulmonary gas exchange) during exercise
Echo-Doppler examination
Intervention Type
DEVICE
Peak systolic velocity and vascular stiffness measurements in the iliac-aortic tract
Interventions
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Cycling test
RAMP and MULTI-STAGE test
Intervention Type
OTHER
Occlusion tests
Occlusion test before and after exercise
Intervention Type
OTHER
NIRS during cycling
NIRS devices measuring oxygenation during exercise
Intervention Type
DEVICE
CPET
Cardiopulmonary exercise testing (heart rate, pulmonary gas exchange) during exercise
Intervention Type
DEVICE
Echo-Doppler examination
Peak systolic velocity and vascular stiffness measurements in the iliac-aortic tract
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* Aged ≥ 18 years and ≤ 40 years
* Trained cyclist or triathlete regularly training at least \~3/week for at least five years and identifying with a particular cycle-sport
* Trained cyclist or triathlete regularly training at least \~3/week for at least five years and identifying with a particular cycle-sport
Exclusion Criteria
* Earlier vascular iliac surgery
* Microvascular abnormalities (e.g. diabetes),
* Vascular abnormalities outside of the iliac region,
* Heart failure (New York Heart Association class \>I),
* Orthopedic/neurological entities potentially limiting exercise capacity,
* Obesity.
* Adipose tissue thickness \> 7.5 mm
These excluding conditions are considered as medical safety precautions to maximal exercise or as risk of unexpected pathophysiological effects confounding our primary outcome measures.
It is known that a high level of adipose tissue thickness (ATT) influences the accuracy of NIRS measurement of underlying muscular tissue. A \> 7.5 mm ATT cut-off point at the site of NIRS measurement determined with a skinfold caliper (Harpenden, Baty International West Sussex, UK) was chosen. The ATT is calculated as half the skinfold thickness.
* Microvascular abnormalities (e.g. diabetes),
* Vascular abnormalities outside of the iliac region,
* Heart failure (New York Heart Association class \>I),
* Orthopedic/neurological entities potentially limiting exercise capacity,
* Obesity.
* Adipose tissue thickness \> 7.5 mm
These excluding conditions are considered as medical safety precautions to maximal exercise or as risk of unexpected pathophysiological effects confounding our primary outcome measures.
It is known that a high level of adipose tissue thickness (ATT) influences the accuracy of NIRS measurement of underlying muscular tissue. A \> 7.5 mm ATT cut-off point at the site of NIRS measurement determined with a skinfold caliper (Harpenden, Baty International West Sussex, UK) was chosen. The ATT is calculated as half the skinfold thickness.
Minimum Eligible Age
18 Years
Maximum Eligible Age
40 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Maxima Medical Center
OTHER
Sponsor Role
lead
Responsible Party
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Martijn van Hooff
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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M van Hooff, MSc
Role: PRINCIPAL_INVESTIGATOR
Maxima Medical Center
Locations
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Maxima MC
Veldhoven, North Brabant, Netherlands
Site Status
Countries
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Netherlands
References
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van Hooff M, Schep G, Meijer E, Bender M, Savelberg H. Near-Infrared Spectroscopy Is Promising to Detect Iliac Artery Flow Limitations in Athletes: A Pilot Study. J Sports Med (Hindawi Publ Corp). 2018 Dec 20;2018:8965858. doi: 10.1155/2018/8965858. eCollection 2018.
Reference Type
BACKGROUND
van Hooff M, Schep G, Bender M, Scheltinga M, Savelberg H. Sport-related femoral artery occlusion detected by near-infrared spectroscopy and pedal power measurements: a case report. Phys Sportsmed. 2021 May;49(2):241-244. doi: 10.1080/00913847.2020.1796182. Epub 2020 Jul 26.
Reference Type
BACKGROUND
Schep G, Bender MH, van de Tempel G, Wijn PF, de Vries WR, Eikelboom BC. Detection and treatment of claudication due to functional iliac obstruction in top endurance athletes: a prospective study. Lancet. 2002 Feb 9;359(9305):466-73. doi: 10.1016/s0140-6736(02)07675-4.
Reference Type
BACKGROUND
Bender MH, Schep G, de Vries WR, Hoogeveen AR, Wijn PF. Sports-related flow limitations in the iliac arteries in endurance athletes: aetiology, diagnosis, treatment and future developments. Sports Med. 2004;34(7):427-42. doi: 10.2165/00007256-200434070-00002.
Reference Type
BACKGROUND
Peach G, Schep G, Palfreeman R, Beard JD, Thompson MM, Hinchliffe RJ. Endofibrosis and kinking of the iliac arteries in athletes: a systematic review. Eur J Vasc Endovasc Surg. 2012 Feb;43(2):208-17. doi: 10.1016/j.ejvs.2011.11.019. Epub 2011 Dec 19.
Reference Type
BACKGROUND
Hinchliffe RJ. Iliac Artery Endofibrosis. Eur J Vasc Endovasc Surg. 2016 Jul;52(1):1-2. doi: 10.1016/j.ejvs.2016.04.006. Epub 2016 May 6. No abstract available.
Reference Type
BACKGROUND
INSITE Collaborators (INternational Study group for Identification and Treatment of Endofibrosis). Diagnosis and Management of Iliac Artery Endofibrosis: Results of a Delphi Consensus Study. Eur J Vasc Endovasc Surg. 2016 Jul;52(1):90-8. doi: 10.1016/j.ejvs.2016.04.004. Epub 2016 May 17.
Reference Type
BACKGROUND
Khan A, Al-Dawoud M, Salaman R, Al-Khaffaf H. Management of Endurance Athletes with Flow Limitation in the Iliac Arteries: A Case Series. EJVES Short Rep. 2018 Jul 20;40:7-11. doi: 10.1016/j.ejvssr.2018.06.001. eCollection 2018.
Reference Type
BACKGROUND
Peake LK, D'Abate F, Farrah J, Morgan M, Hinchliffe RJ. The Investigation and Management of Iliac Artery Endofibrosis: Lessons Learned from a Case Series. Eur J Vasc Endovasc Surg. 2018 Apr;55(4):577-583. doi: 10.1016/j.ejvs.2018.01.018. Epub 2018 Mar 13.
Reference Type
BACKGROUND
Schep G, Bender MH, Schmikli SL, Mosterd WL, Hammacher ER, Scheltinga M, Wijn PF. Recognising vascular causes of leg complaints in endurance athletes. Part 2: the value of patient history, physical examination, cycling exercise test and echo-Doppler examination. Int J Sports Med. 2002 Jul;23(5):322-8. doi: 10.1055/s-2002-33142.
Reference Type
BACKGROUND
Barstow TJ. Understanding near infrared spectroscopy and its application to skeletal muscle research. J Appl Physiol (1985). 2019 May 1;126(5):1360-1376. doi: 10.1152/japplphysiol.00166.2018. Epub 2019 Mar 7.
Reference Type
BACKGROUND
Perrey S, Ferrari M. Muscle Oximetry in Sports Science: A Systematic Review. Sports Med. 2018 Mar;48(3):597-616. doi: 10.1007/s40279-017-0820-1.
Reference Type
BACKGROUND
Boezeman RP, Moll FL, Unlu C, de Vries JP. Systematic review of clinical applications of monitoring muscle tissue oxygenation with near-infrared spectroscopy in vascular disease. Microvasc Res. 2016 Mar;104:11-22. doi: 10.1016/j.mvr.2015.11.004. Epub 2015 Nov 11.
Reference Type
BACKGROUND
Cornelis N, Chatzinikolaou P, Buys R, Fourneau I, Claes J, Cornelissen V. The Use of Near Infrared Spectroscopy to Evaluate the Effect of Exercise on Peripheral Muscle Oxygenation in Patients with Lower Extremity Artery Disease: A Systematic Review. Eur J Vasc Endovasc Surg. 2021 May;61(5):837-847. doi: 10.1016/j.ejvs.2021.02.008. Epub 2021 Mar 30.
Reference Type
BACKGROUND
Kleinloog JPD, van Hooff M, Savelberg HHCM, Meijer EJ, Schep G. Pedal power measurement as a diagnostic tool for functional vascular problems. Clin Biomech (Bristol). 2019 Jan;61:211-216. doi: 10.1016/j.clinbiomech.2018.12.020. Epub 2018 Dec 21.
Reference Type
BACKGROUND
Arnold J, Yogev A, Koehle MS. Evaluating Arterial Blood Flow Limitation Using Muscle Oxygenation and Cycling Power. Clin J Sport Med. 2022 May 1;32(3):e268-e275. doi: 10.1097/JSM.0000000000000942. Epub 2021 May 7.
Reference Type
BACKGROUND
Jamnick NA, Botella J, Pyne DB, Bishop DJ. Manipulating graded exercise test variables affects the validity of the lactate threshold and V O 2 peak . PLoS One. 2018 Jul 30;13(7):e0199794. doi: 10.1371/journal.pone.0199794. eCollection 2018.
Reference Type
BACKGROUND
Ihsan M, Abbiss CR, Lipski M, Buchheit M, Watson G. Muscle oxygenation and blood volume reliability during continuous and intermittent running. Int J Sports Med. 2013 Jul;34(7):637-45. doi: 10.1055/s-0032-1331771. Epub 2013 Mar 22.
Reference Type
BACKGROUND
Skovereng K, Ettema G, van Beekvelt M. Local muscle oxygen consumption related to external and joint specific power. Hum Mov Sci. 2016 Feb;45:161-71. doi: 10.1016/j.humov.2015.11.009. Epub 2015 Dec 1.
Reference Type
BACKGROUND
Heres HM, Schoots T, Tchang BCY, Rutten MCM, Kemps HMC, van de Vosse FN, Lopata RGP. Perfusion dynamics assessment with Power Doppler ultrasound in skeletal muscle during maximal and submaximal cycling exercise. Eur J Appl Physiol. 2018 Jun;118(6):1209-1219. doi: 10.1007/s00421-018-3850-y. Epub 2018 Mar 22.
Reference Type
BACKGROUND
Bopp CM, Townsend DK, Barstow TJ. Characterizing near-infrared spectroscopy responses to forearm post-occlusive reactive hyperemia in healthy subjects. Eur J Appl Physiol. 2011 Nov;111(11):2753-61. doi: 10.1007/s00421-011-1898-z. Epub 2011 Mar 16.
Reference Type
BACKGROUND
Niemeijer VM, Spee RF, Jansen JP, Buskermolen AB, van Dijk T, Wijn PF, Kemps HM. Test-retest reliability of skeletal muscle oxygenation measurements during submaximal cycling exercise in patients with chronic heart failure. Clin Physiol Funct Imaging. 2017 Jan;37(1):68-78. doi: 10.1111/cpf.12269. Epub 2015 Jul 3.
Reference Type
BACKGROUND
Chirinos JA, Segers P, Hughes T, Townsend R. Large-Artery Stiffness in Health and Disease: JACC State-of-the-Art Review. J Am Coll Cardiol. 2019 Sep 3;74(9):1237-1263. doi: 10.1016/j.jacc.2019.07.012.
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BACKGROUND
Stocker F, Von Oldershausen C, Paternoster FK, Schulz T, Oberhoffer R. End-exercise DeltaHHb/DeltaVO2 and post-exercise local oxygen availability in relation to exercise intensity. Clin Physiol Funct Imaging. 2017 Jul;37(4):384-393. doi: 10.1111/cpf.12314. Epub 2015 Nov 17.
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BACKGROUND
Rosenberry R, Nelson MD. Reactive hyperemia: a review of methods, mechanisms, and considerations. Am J Physiol Regul Integr Comp Physiol. 2020 Mar 1;318(3):R605-R618. doi: 10.1152/ajpregu.00339.2019. Epub 2020 Feb 5.
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BACKGROUND
McLay KM, Fontana FY, Nederveen JP, Guida FF, Paterson DH, Pogliaghi S, Murias JM. Vascular responsiveness determined by near-infrared spectroscopy measures of oxygen saturation. Exp Physiol. 2016 Jan;101(1):34-40. doi: 10.1113/EP085406. Epub 2015 Dec 6.
Reference Type
BACKGROUND
Other Identifiers
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NL79767.015.21
Identifier Type: -
Identifier Source: org_study_id
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