Peripheral Stimulation Device to Improve Coronary Flow Reserve in Coronary Artery Disease

NCT01853410 | Completed Phase 1

• 1 other identifier: 103661
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease; Ischemic Disease

Keywords

coronary artery disease; coronary flow reserve; endothelial function

Outcome Measures

Primary Outcomes (1)

• Change in Coronary Flow Reserve following stimulation with gekoTM device

  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

  Time = 0; Time = post 120 sec stimulation (low setting); Time = post 120 sec stimulation (high setting)

Secondary Outcomes (3)

• Change in Popliteal artery vessel diameter following 60 mins stimulation with gekoTM device

  Time = 0; Time = post 60 mins stimulation with gekoTM device

• Change in Popliteal artery vessel Doppler flow velocity following 60 mins stimulation with gekoTM device

  Time = 0; Time = post 60 mins stimulation with gekoTM device

• Change in Endothelial function following 60 mins stimulation with gekoTM device

  Time = 0; Time = post 60 mins stimulation with gekoTM device

Study Arms (1)

gekoTM device application

EXPERIMENTAL

Single arm study. Application of gekoTM device as described above with assessment of effect on coronary flow and endothelial function.

Device: gekoTM

Interventions

gekoTM DEVICE

gekoTM device application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Significant valvular heart disease or left ventricular dysfunction.
• Contraindication to the administration of intracoronary adenosine.
• Latex allergy.
• Significant peripheral motor neuropathy.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A5A5, Canada

Location

Related Publications (24)

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  BACKGROUND

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MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Shahar Lavi, MD

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 8, 2013
• First Posted: May 15, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: October 1, 2015
• Last Updated: November 26, 2015

Record last verified: 2015-11

Locations

CA (1)