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Peripheral Stimulation Device to Improve Coronary Flow Reserve in Coronary Artery Disease (PERCCAD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01853410
First Posted: May 15, 2013
Last Update Posted: November 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shahar Lavi, Lawson Health Research Institute
  Purpose
The purpose of the PERCCAD Study is to investigate the effect of the gekoTM device (a non-invasive calf muscle stimulator approved for use to improve blood flow by Health Canada) on coronary blood flow in order to assess its potential role as a therapeutic modality for the treatment of symptomatic coronary artery disease (CAD). This will occur in patients already undergoing coronary angiography and percutaneous coronary intervention (PCI) as part of their usual medical care. Further, the investigators will also assess the overall effect on blood flow in the body using non-invasive techniques. The primary objective of the PERCCAD study is to assess the effect of the gekoTM device on coronary blood flow in patients with symptomatic CAD who are undergoing invasive angiographic assessment and management with PCI. This evaluation of the gekoTM device is to be performed at the time of the patient's already planned invasive assessment and management so that invasive data can be collected without exposing the patient to risks other than those already associated with their planned procedure and usual clinical care. The secondary objective of the study is to assess the effect of muscle stimulation with the gekoTM device on endothelial function and peripheral blood flow measured via non-invasive techniques.

Condition Intervention Phase
Coronary Artery Disease Ischemic Disease Device: gekoTM Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Peripheral Stimulation Device to Improve Coronary Flow Reserve in Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by Shahar Lavi, Lawson Health Research Institute:

Primary Outcome Measures:
  • Change in Coronary Flow Reserve following stimulation with gekoTM device [ Time Frame: Time = 0; Time = post 120 sec stimulation (low setting); Time = post 120 sec stimulation (high setting) ]
    The change in the effect of the gekoTM device on coronary blood flow as measured by coronary flow reserve using a Doppler tipped coronary flow wire inserted into the coronary artery tree via a percutaneous technique, will be measured at baseline, after 120 sec of stimulation with the gekoTM device on low frequency setting, and after 120 sec of stimulation with the gekoTM device on high frequency setting


Secondary Outcome Measures:
  • Change in Popliteal artery vessel diameter following 60 mins stimulation with gekoTM device [ Time Frame: Time = 0; Time = post 60 mins stimulation with gekoTM device ]

    Change in popliteal artery vessel diameter will be recorded using a surface ultrasound probe at baseline and following 60 mins of treatment with the gekoTM.

    This study will be performed on a separate visit following the PCI procedure.


  • Change in Popliteal artery vessel Doppler flow velocity following 60 mins stimulation with gekoTM device [ Time Frame: Time = 0; Time = post 60 mins stimulation with gekoTM device ]
    Change in popliteal artery vessel Doppler flow velocity will be recorded using a surface ultrasound probe at baseline and following 60 mins of treatment with the gekoTM. This study will be performed on a separate visit following the PCI procedure.

  • Change in Endothelial function following 60 mins stimulation with gekoTM device [ Time Frame: Time = 0; Time = post 60 mins stimulation with gekoTM device ]
    The change in Endothelial function study will by measured using the EndoPAT2000 following 60 mins of treatment with the gekoTM. This study will be performed on a separate visit following the PCI procedure.


Enrollment: 10
Study Start Date: July 2013
Study Completion Date: October 2015
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: gekoTM device application
Single arm study. Application of gekoTM device as described above with assessment of effect on coronary flow and endothelial function.
Device: gekoTM

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 - 80.
  2. Symptomatic coronary artery disease and already undergoing invasive angiographic assessment and percutaneous coronary intervention.

Exclusion criteria:

  1. Significant valvular heart disease or left ventricular dysfunction.
  2. Contraindication to the administration of intracoronary adenosine.
  3. Latex allergy.
  4. Significant peripheral motor neuropathy.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853410


Locations
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A5A5
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Shahar Lavi, MD London Health Sciences Centre
  More Information

Publications:
Loh PH, Cleland JG, Louis AA, Kennard ED, Cook JF, Caplin JL, Barsness GW, Lawson WE, Soran OZ, Michaels AD. Enhanced external counterpulsation in the treatment of chronic refractory angina: a long-term follow-up outcome from the International Enhanced External Counterpulsation Patient Registry. Clin Cardiol. 2008 Apr;31(4):159-64. doi: 10.1002/clc.20117.
Masuda D, Nohara R, Hirai T, Kataoka K, Chen LG, Hosokawa R, Inubushi M, Tadamura E, Fujita M, Sasayama S. Enhanced external counterpulsation improved myocardial perfusion and coronary flow reserve in patients with chronic stable angina; evaluation by(13)N-ammonia positron emission tomography. Eur Heart J. 2001 Aug;22(16):1451-8.
Michaels AD, Accad M, Ports TA, Grossman W. Left ventricular systolic unloading and augmentation of intracoronary pressure and Doppler flow during enhanced external counterpulsation. Circulation. 2002 Sep 3;106(10):1237-42.
Yang DY, Wu GF. Vasculoprotective properties of enhanced external counterpulsation for coronary artery disease: beyond the hemodynamics. Int J Cardiol. 2013 Jun 5;166(1):38-43. doi: 10.1016/j.ijcard.2012.04.003. Epub 2012 May 4. Review.
Jawad H. The effect of a novel electrical stimulation method for improving lower limb blood flow in healthy volunteers. 2012
Tucker A, Maass A, Bain D, Chen LH, Azzam M, Dawson H, Johnston A. Augmentation of venous, arterial and microvascular blood supply in the leg by isometric neuromuscular stimulation via the peroneal nerve. Int J Angiol. 2010 Spring;19(1):e31-7.
Akhtar M, Wu GF, Du ZM, Zheng ZS, Michaels AD. Effect of external counterpulsation on plasma nitric oxide and endothelin-1 levels. Am J Cardiol. 2006 Jul 1;98(1):28-30. Epub 2006 May 3.
Bonetti PO, Barsness GW, Keelan PC, Schnell TI, Pumper GM, Kuvin JT, Schnall RP, Holmes DR, Higano ST, Lerman A. Enhanced external counterpulsation improves endothelial function in patients with symptomatic coronary artery disease. J Am Coll Cardiol. 2003 May 21;41(10):1761-8.
Rubinshtein R, Kuvin JT, Soffler M, Lennon RJ, Lavi S, Nelson RE, Pumper GM, Lerman LO, Lerman A. Assessment of endothelial function by non-invasive peripheral arterial tonometry predicts late cardiovascular adverse events. Eur Heart J. 2010 May;31(9):1142-8. doi: 10.1093/eurheartj/ehq010. Epub 2010 Feb 24.
Gokce N, Keaney JF Jr, Hunter LM, Watkins MT, Menzoian JO, Vita JA. Risk stratification for postoperative cardiovascular events via noninvasive assessment of endothelial function: a prospective study. Circulation. 2002 Apr 2;105(13):1567-72.
Bonetti PO, Pumper GM, Higano ST, Holmes DR Jr, Kuvin JT, Lerman A. Noninvasive identification of patients with early coronary atherosclerosis by assessment of digital reactive hyperemia. J Am Coll Cardiol. 2004 Dec 7;44(11):2137-41.
Hamburg NM, Keyes MJ, Larson MG, Vasan RS, Schnabel R, Pryde MM, Mitchell GF, Sheffy J, Vita JA, Benjamin EJ. Cross-sectional relations of digital vascular function to cardiovascular risk factors in the Framingham Heart Study. Circulation. 2008 May 13;117(19):2467-74. doi: 10.1161/CIRCULATIONAHA.107.748574. Epub 2008 May 5.
Gould KL, Lipscomb K. Effects of coronary stenoses on coronary flow reserve and resistance. Am J Cardiol. 1974 Jul;34(1):48-55.
Hoffman JI. Maximal coronary flow and the concept of coronary vascular reserve. Circulation. 1984 Aug;70(2):153-9. Review.
Collins P. Coronary flow reserve. Br Heart J. 1993 Apr;69(4):279-81.
Wilson RF, Johnson MR, Marcus ML, Aylward PE, Skorton DJ, Collins S, White CW. The effect of coronary angioplasty on coronary flow reserve. Circulation. 1988 Apr;77(4):873-85.
De Bruyne B, Baudhuin T, Melin JA, Pijls NH, Sys SU, Bol A, Paulus WJ, Heyndrickx GR, Wijns W. Coronary flow reserve calculated from pressure measurements in humans. Validation with positron emission tomography. Circulation. 1994 Mar;89(3):1013-22.
Casella G, Leibig M, Schiele TM, Schrepf R, Seelig V, Stempfle HU, Erdin P, Rieber J, König A, Siebert U, Klauss V. Are high doses of intracoronary adenosine an alternative to standard intravenous adenosine for the assessment of fractional flow reserve? Am Heart J. 2004 Oct;148(4):590-5.
Murtagh B, Higano S, Lennon R, Mathew V, Holmes DR Jr, Lerman A. Role of incremental doses of intracoronary adenosine for fractional flow reserve assessment. Am Heart J. 2003 Jul;146(1):99-105.
Jeremias A, Whitbourn RJ, Filardo SD, Fitzgerald PJ, Cohen DJ, Tuzcu EM, Anderson WD, Abizaid AA, Mintz GS, Yeung AC, Kern MJ, Yock PG. Adequacy of intracoronary versus intravenous adenosine-induced maximal coronary hyperemia for fractional flow reserve measurements. Am Heart J. 2000 Oct;140(4):651-7.
Zijlstra F, Juillière Y, Serruys PW, Roelandt JR. Value and limitations of intracoronary adenosine for the assessment of coronary flow reserve. Cathet Cardiovasc Diagn. 1988;15(2):76-80.
Kuvin JT, Patel AR, Sliney KA, Pandian NG, Sheffy J, Schnall RP, Karas RH, Udelson JE. Assessment of peripheral vascular endothelial function with finger arterial pulse wave amplitude. Am Heart J. 2003 Jul;146(1):168-74.
Kuvin JT, Mammen A, Mooney P, Alsheikh-Ali AA, Karas RH. Assessment of peripheral vascular endothelial function in the ambulatory setting. Vasc Med. 2007 Feb;12(1):13-6.
Hamburg NM, Benjamin EJ. Assessment of endothelial function using digital pulse amplitude tonometry. Trends Cardiovasc Med. 2009 Jan;19(1):6-11. doi: 10.1016/j.tcm.2009.03.001. Review.

Responsible Party: Shahar Lavi, Principle Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01853410     History of Changes
Other Study ID Numbers: 103661
First Submitted: May 8, 2013
First Posted: May 15, 2013
Last Update Posted: November 26, 2015
Last Verified: November 2015

Keywords provided by Shahar Lavi, Lawson Health Research Institute:
coronary artery disease
coronary flow reserve
endothelial function

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases


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