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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Shahar Lavi, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01853410
First received: May 8, 2013
Last updated: October 16, 2014
Last verified: October 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Peripheral Stimulation Device to Improve Coronary Flow Reserve in Coronary Artery Disease

Further study details as provided by 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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 10
Study Start Date: July 2013
Estimated Study Completion Date: July 2015
Primary Completion Date: April 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Responsible Party: Shahar Lavi, Principle Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01853410     History of Changes
Other Study ID Numbers: 103661
Study First Received: May 8, 2013
Last Updated: October 16, 2014
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on November 20, 2014