Clinical testing

 

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Since 2015, the Russian Ministry of Health has been implementing the clinical testing programme for the methods of prevention, diagnosis, treatment and rehabilitation (Order No. 433n dated July 10, 2015 “On Approval of the Regulations on Clinical Testing of Prevention, Diagnosis, Treatment and Rehabilitation Methods and Medical Care” and standard protocol form for clinical testing.

Clinical testing is the practical use of previously unused methods of prevention, diagnosis, treatment and rehabilitation in medical care to confirm their effectiveness.

Since 2015, Almazov Centre has developed and tested 30 protocols in 4 areas:

  • Cardiovascular surgery
  • Neurosurgery
  • Endocrinology
  • Cardiology

Clinical testing protocols in figures

Данные о протоколах клинической апробации-1

Clinical testing applications in 2019

Заявки по клинической апробации в 2019-1     Заявки по клинической апробации в 2019-2

Clinical testing applications in 2020

Заявки по клинической апробации за 2020-1     Заявки по клинической апробации за 2020-2

The protocol «Clinical testing of myocardium ischemic postconditioning method in patients with acute coronary syndrome with ST segment elevation» proved its clinical and economic effectiveness. (5-15)

The method has been recommended by the Ministry of Health to be included in clinical guidelines and implementation into clinical practice.

About Method

The proposed method of myocardial protection by ischemic postconditioning is meant to create several short episodes of reperfusion-ischemia after prolonged myocardial ischemia. The method can be used in patients with ST segment elevation at primary PCI to prevent ischemic and reperfusion injury of the myocardium. Technically, the method is implemented by modifying PPCI procedure with the creation of four episodes of 30-second reperfusion and 30-second ischemia in the territory of the infarction-dependent artery during the intervention.

The first ischemia episode occurs 60 seconds after pre-dilatation of artery is done. A coronary stent is implanted 30 seconds after the end of the last ischemia episode. The use of this method will contribute to a faster and complete recovery of the functional myocardium state via blood flow restoration as well as to reducing the volume of irreversibly damaged myocardium and the level of biomarkers of myocardial damage reflecting in reduced severity of irreversible reperfusion injury.

Areas and protocols

Сердечно-сосудистая хирургия
  1. Clinical testing of the method for constant His bundle stimulation in adult patients with indications for constant two-chamber stimulation (2019-26-41)

Coordinator: Lebedev D.

Period: 2020—2021

Testing method: method of stimulation lead positioning directly in the area of the His bundle

Publications:

Hindricks G., Pokushalov E., Urban L., Taborsky M., Kuck K.H., Lebedev D.S. et al. Performance of a new leadless implantable cardiac monitor in detecting and quantifying atrial fibrillation: results of the XPECT trial. Circulation. Arrhythm electrophysiol. – 2010. – V. 3. – P. 141–147. Access link: https://doi.org/10.1161/CIRCEP.109.877852.

  1. Clinical testing of carotid stenting method using double-layer stents and intraoperative optical coherence tomography (2018-12-5)

Coordinator: Chernyavsky M.

Period: 2018—2020

Testing method: carotid stenting method with double-layer stents

Publications:

Carnelli D., Pennati G., Villa T. et al. Mechanical properties of open-cell, self expandable shape memory alloy carotid stents // Artif Organs. 2011. V. 35. P. 74—80. Access link: https://doi.org/10.1111/j.1525—1594.2010.01018.x.

  1. Clinical testing of vibration recanalization of extended occlusions in lower limb arteries (2018-12-6)

Coordinator: Chernyavsky M.

Period: 2018—2020

Testing method: recanalization of chronic extended occlusions in femoral-popliteal arterial segment

Publications:

Banerjee, S., et al. Comparative Assessment of Guidewire and Microcatheter vs a Crossing Device-Based Strategy to Traverse Infrainguinal Peripheral Artery Chronic Total Occlusions. Journal of Endovascular Therapy 2015, Vol. 22 (4) 525–534. Access link: https://doi/10.1177/1526602815587707.

  1. Clinical testing of radiofrequency ablation of sympathetic nerves located in the adventitia of the renal arteries in patients with resistant arterial hypertension (2018-12-11)

Coordinators: Emelyanov I., Mikhailov E.

Period: 2020—2021

Testing method: renal artery denervation method

Publications:

Townsend RR, Mahfoud F, Kandzari DE, Kario K, Pocock S, Weber MA, Ewen S, Tsioufis K, Tousoulis D, Sharp ASP, Watkinson AF, Schmieder RE, Schmid A, Choi JW, East C, Walton A, Hopper I, Cohen DL, Wilensky R, Lee DP, Ma A, Devireddy CM, Lea JP, Lurz PC, Fengler K, Davies J, Chapman N, Cohen SA, DeBruin V, Fahy M, Jones DE, Rothman M, Böhm M; SPYRAL HTN-OFF MED trial investigators*. Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial. Lancet. 2017 Nov 11;390 (10108):2160—2170. doi: 10.1016/S0140—6736 (17) 32281-X.

  1. Clinical testing of surgical treatment of atrial fibrillation in the correction of valvular heart disease (2017-21-11)

Coordinators: Moiseeva O., Isakov S.

Period: 2017—2018

Testing method: performing the MAZE IV biomaterial procedure using only a bipolar RF electrode

Publications:

Cox, J.L.  Cardiac surgery for arrhythmias // J. Cardiovasc. Electrophysiol. – 2004. – Vol. 15, № 2. – P. 250–262. Access link: https://doi.org/10.1046/j.1540—8167.2004.03656.x.

  1. Clinical testing of long-term electrocardiogram monitoring with implantable cardiac monitors and remote telemetry to identify an arrhythmogenic cause of ischemic stroke of unspecified etiology and secondary prevention of cerebrovascular accidents (2017-21-12)

Coordinator: Lebedev D.

Period: 2017—2018

Testing method: method of continuous long-term recording of electrocardiogram using implantable cardiac monitors

Publications:

Cotter PE, Martin PJ, Ring L, Warburton EA, Belham M, Pugh PJ. Incidence of atrial fibrillation detected by implantable loop recorders in unexplained stroke. Neurology 2013; 80 (17): 1546-50. Access link: https://doi.org/10.1212/WNL.0b013e31828f1828.

  1. Clinical testing of multipolar left ventricular pacing in optimizing the response to cardiac resynchronization therapy in CHF patients (2017-21-13)

Coordinator: Lebedev D.

Period: 2017—2018

Testing method: Using multipolar electrodes of the left ventricle in cardiac resynchronization therapy devices

Publications:

Linde C, Leclercq C, Rex S, et al. Long-term benefits of biventricular pacing in congestive heart failure: results from the MUltisite STimulation in cardiomyopathy (MUSTIC) study // J Am Coll of Cardiol. — 2002; 40:111-118. Access link: https://doi.org/10.1016/S0735—1097 (02) 01932-0.

  1. Clinical testing of heart immobilization in the surgical treatment of hypertrophic cardiomyopathy (HCM) by transaortic access (2016-19-5)

 

Coordinator: Gurschenkov A.

Period: 2016—2017

Testing method: method of cardiac mobilization in septal myomectomy

 

Publications:

Heart mobilizing in the surgical treatment of hypertrophic obstructive cardiomyopathy by transaortic access. Patent for invention No. 2511246

  1. Clinical testing of modulating cardiac contractility for CHF treatment (2016-19-16)

Coordinators: Mikhailov E., Sitnikova M.

Period: 2016—2017

Testing method: implantation of a pacemaker device in the subclavian region

Publications:

Liu Ming, Fang Fang, Luo Xiu Xia, et al. Improvement of long-term survival by cardiac contractility modulation in heart failure patients: A case-control study // Int. J. Cardiol. — 2016; 21826. Access link: https://doi.org/10.1016/j.ijcard.2016.01.071.

  1. Clinical testing of ischemic postconditioning of the myocardium in aortic and aortic valve replacement (5-1)

Coordinator: Bautin A.

Period: 2015—2017

Testing method: modifying the perfusion regime of cardiac surgery

Publications:

Darling CE, Jiang R, Maynard M, Whittaker P, Vinten-Johansen J, Przyklenk K. Postconditioning via stuttering reperfusion limits myocardial infarct size in rabbit hearts: role of ERK1/2. Am J Physiol Heart Circ Physiol. 2005;289 (4):H1618-26. Access link: https://doi.org/10.1152/ajpheart.00055.2005.

  1. Clinical testing of distant ischemic preconditioning of the myocardium as a method of cardiac protection during coronary bypass grafting and prosthetics of heart valves in extracorporeal circulation (5-8)

Coordinator: Bautin A.

Period: 2015—2017

Testing method: modified method of distant preconditioning for open heart surgery

Publications:

Gho BC, Schoemaker RG, van den Doel MA, Duncker DJ, Verdouw PD. Myocardial protection by brief ischemia in noncardiac tissue. Circulation 1996;94:2193–2200. Access mode: https://doi.org/10.1161/01.CIR.94.9.2193.

  1. Clinical testing of pharmacological preconditioning during surgery with cardiopulmonary bypass (5-10)

Coordinator: Bautin A.E.

Period: 2015—2017

Testing method: two simultaneous methods of cardiac protection

Publications:

De Hert S., ten Broecke P., Mertens E. et al. Sevoflurane but not propofol preserves myocardial function in coronary surgery patients // Anesthesiology. — 2002. – Vol. 97. – P. 42–49. Access link: https://doi.org/10.1097/00000542-200207000-00007.

  1. Clinical testing of ischemic myocardial postconditioning in patients with acute coronary syndrome with ST segment elevation (5-15)

Coordinator: Yakovlev A.

Period: 2015—2017

Testing method: reducing the volume of irreversibly damaged myocardium

Publications:

Darling CE, Jiang R, Maynard M, Whittaker P, Vinten-Johansen J, Przyklenk K. Postconditioning via stuttering reperfusion limits myocardial infarct size in rabbit hearts: role of ERK1/2. Am J Physiol Heart Circ Physiol. 2005;289 (4):H1618-26. Access link: https://doi.org/10.1152/ajpheart.00055.2005.

  1. Clinical testing of diagnostic method of functional significance of coronary artery stenosis using perfusion PET to determine indications for endovascular revascularization (5-16)

Coordinator: Ryzhkova D.

Period: 2015—2017

Testing method: method for assessing myocardial perfusion and calculating coronary reserve

Publications:

Gould KL, Johnson NP, Bateman TM, et al.  Anatomic versus physiologic assessment of coronary artery disease. Role of coronary flow reserve, fractional flow reserve, and positron emission tomography imaging in revascularization decision-making. // J Am Coll Cardiol. — 2013. — Vol. 29. — № 62 (18). — P. 1639-53. Access link: https://doi.org/10.1016/j.jacc.2013.07.076.

Cardiology
  1. Clinical testing of immunomodulatory therapy in children with inflammatory myocardial diseases (5-D2)

Coordinator: Pervunina T.

Period: 2015—2017

Testing method: method of using immunoglobulins G

Publications: Muller J., Wallukat G., Dandel M. et al. Immunoglobulin adsorption in patients with idiopathic dilated cardiomyopathy. Circulation 2000;101:385–391. Access link: https://doi.org/10.1161/01.CIR.101.4.385.

Neurosurgery
  1. Clinical testing of postoperative pain treatment as a part of multimodal analgesia in children after reconstructive operations on scalp bones (2019-26-62)

Coordinator: Khachatryan W.

Period: 2020—2022

Testing method: method of regional analgesia – infiltration of the skin flap with ropivocaine

Publications:

Kim J.S., Kim G.W., Park D.H., Ahn H.E., Chang M.Y., Kim J.Y. Effects of scalp nerve block on pain and emergence agitation after pediatric nevus surgery: a clinical trial. // Acta Anaesthesiol Scand. 2017:Sep;61 (8):935-941. Access link: https://doi.org/10.1111/aas.12942.

  1. Clinical testing of «small» posterior cranial fossa syndrome therapy using cranial distraction (D-2018-47-5)

Coordinator: Khachatryan W.

Period: 2018—2020

Testing method: modified posterior cranial distraction method

Publications:

Juling Ong., Raymond J. Harshbarger III, Patrick Kelley. Posterior Cranial Vault Distraction Osteogenesis: Evolution of Technique//Semin Plast Surg. -2014 Nov;28 (4):163-178. Access link: https://dx.doi.org/10.1055/s-0034-1390169.

  1. Clinical testing of retrograde laser vaporization of intervertebral hernia in the lumbar spine (2017-21-4)

Coordinator: Ivanenko A.

Period: 2017—2019

Testing method: minimally invasive method of percutaneous retrograde laser vaporization of an intervertebral hernia in the lumbar spine

Publications:

Spine osteochondrosis therapy. Patent for invention No. 2379072 dated 20.01.2010

  1. Clinical testing of intraoperative ultrasound and neurophysiological monitoring of neuromuscular conductibility during peripheral nerves surgery (2017-21-18)

Coordinator: Orlov A.

Period: 2017—2019

Testing method: intraoperative ultrasound and neuromuscular conductibility

Publications:

Intraoperative electrodiagnostics of peripheral nerves. Patent for invention No. 2402355

  1. Clinical testing of consequences after spinal hernia surgical treatment in children (2017-21-32)

Coordinator: Khachatryan W.

Period: 2017—2019

Testing method: prevention and treatment of spinal hernia consequences in children

Publications:

Surgical treatment of fixed spinal cord syndrome with secondary fixation. Patent for invention No. 2574715

  1. Clinical testing of the ventriculo-sinus-transversal atriostomy therapy in patients with hydrocephaly (2017-21-33)

Coordinator: Khachatryan W.

Period: 2017—2018

Testing method: venous catheter implantation the right atrium cavity

Publications:

Khachatryan. Ventriculo-Sinus Transversal Shunt in the Treatment of Hydrocephalus. Pediatric neurosurgery and neurology. No. 1 (43) 2015, 70-79. Access link: https://doi.org/10.18705/2311—4495-2017-4-1-20-28.

  1. Clinical testing of the laminoplasty with three-plane elastic fixators in surgical treatment of multilevel stenosis of the cervical spine of undefined origin (2016-19-14)

Coordinator: Davydov E.

Period: 2016—2017

Testing method: laminoplasty on cervical spine with elastic nitinol fixators

Publications:

Prosthetics fixator for spine ligament and bone structures during laminoplasty. Patent for invention No. 2514121

  1. Clinical testing of frameless neuronavigation in complex treatment of patients with chiasmatic-sellar tumors (2016-19-17)

Coordinator: Rostovtsev D.

Period: 2016—2017

Testing method: intraoperative frameless neuronavigation

Publications:

Basic principles and clinical applications of neuronavigation and intraoperative computed tomography Text. / P. Grunert, W. Mliller-Forell, K. Darabi, et.al. // Comput Aided Surg. 1998. — Vol. 3. — No. 4. — P. 166-173. Access link: https://doi.org/10.3109/10929089809148141.

  1. Clinical testing of translingual non-invasive neuromodulation for ataxia correction in patients with consequence of neurosurgical operations in tumors of supra- and subtentorial localization (2016-19-31)

Coordinator: Kondratyeva E.

Period: 2016—2017

Testing method: physical rehabilitation based on translingual electrical stimulation with portable neuromodulating stimulator

Publications:

Wildenberg J.C., Tyler M.E., Danilov Y.P., et al. Electrical Tongue Stimulation Normalizes Activity Within the Motion-Sensitive Brain Network in Balance-Impaired Subjects as Revealed by Group Independent Component Analysis // Brain Connect. 2011 Sep; 1 (3): 255-265. Access link: https://doi.org/10.1089/brain.2011.0029.

  1. Clinical testing of intraoperative ultrasound monitoring in patients with glial tumors of supratentorial localization (2016-19-32)

Coordinator: Rostovtsev D.

Period: 2016—2017

Testing method: intraoperative ultrasound guidance for minimally traumatic encephalotomy

Publications:

Hammoud M.A. Use of intraoperative ultrasound for localizing tumors and determining the extent of resection: a comparative study with magnetic resonance imaging / M.A. Hammoud, B.L. Ligon, R. el Souki et al. // J. Neurosurg. — 1996. — No. 84 (5). — R. 737-741. Access link: https://doi.org/10.3171/jns.1996.84.5.0737.

  1. Clinical testing of intraoperative photodynamic therapy in patients with malignant astrocytic tumors of supratentorial localization (2016-19-33)

Coordinator: Rostovtsev D.

Period: 2016—2017

Testing method: application of fluorescence control in neurosurgical oncology

Publications:

Olyushin, V.E. A new method of photodynamic therapy in the complex treatment of glial brain tumors / V.E. Olyushin, A.V. Comfort, A.Yu. Ulitin // Ros. biother. journal — 2007. — T. 6, No. 1. — P. 23

  1. Clinical testing of superselective arterial embolization in patients with hypervascular tumors of the skull base (2016-19-35)

Coordinator: Radjabov S.

Period: 2016—2017

Testing method: a technique for blood loss reducing in the surgical treatment of skull base tumors

Publications:

Arustamyan S.R., Dolgushin A.Yu. Embolization of extra-intracranial tumors // Problems of Neurosurgery. — 2002. — No. 3. — S.30-34

  1. Clinical testing of ventriculo-sinustransversostomy in patients with hydrocephalus (5-D)

Coordinator: Khachatryan W.

Period: 2015—2017

Testing method: shunting for hydrocephalus treatment

Publications:

Treating method for hydrocephalus. Patent for invention No. 1176894 dated 08.05.85

Endocrinology
  1. Clinical testing of two-sided simultaneous blood sampling from the cavernous and inferior petrous sinuses with ACTH centre gradient / periphery gradient and ACTH / prolactin normalized ratio for the differential diagnosis of ACTH-dependent hypercortisolism (2019-26-45)

Coordinator: Grineva E.

Period: 2020—2022

Testing method: joint catheterization of cavernous and inferior petrosal sinuses

Publications:

Grant P, Dworakowska D, Carroll P Maximizing the accuracy of Inferior petrosal sinus sampling: validation of the use of Prolactin as a marker of pituitary venous effluent in the diagnosis of Cushing's disease. Clin Endocrinol (Oxf). 2012 Apr; 76 (4): 555-9. Access link: https://doi.org/10.1111/j.1365—2265.2011.04257.x.

  1. Clinical testing of cavernous and inferior petrous sinuses catheterization for differential diagnosis of ACTH-dependent hypercortisolism and optimal tactics choice (2016-19-13)

Coordinator: Grineva E.

Period: 2016—2017

Testing method: joint catheterization of cavernous and inferior petrosal sinuses

Publications:

Newell-Price J, Trainer P, Besser M, et al. The diagnosis and differential diagnosis of Cushing's syndrome and pseudo-Cushing's state // Endocrine Review. — 1998. — R.19647-672. Access link: https://doi.org/10.1210/edrv.19.5.0346.