Neurostimulation to Treat Refractory Angina Pectoris Pain (STARTSTIM)

August 26, 2010 updated by: MedtronicNeuro

STARTSTIM - Stimulation Therapy for Angina Refractory To Standard Treatments, Interventions and Medications

The therapy under investigation involves an implanted Medtronic neurostimulation system to relieve symptoms of angina pectoris pain. Electrical impulses are applied to targeted areas of the spinal cord through an implanted lead (a flexible insulated wire) that is powered by an implanted battery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

228

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Contact Medtronic for exact location
    • Ontario
      • Ottawa, Ontario, Canada
        • Contact Medtronic for exact location
  • United States
    • Florida
      • Gainesville, Florida, United States
        • Contact Medtronic for exact location
    • Indiana
      • Indianapolis, Indiana, United States
        • Contact Medtronic for exact location
    • Massachusetts
      • Boston, Massachusetts, United States
        • Contact Medtronic for exact location
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Contact Medtronic for exact location
      • Rochester, Minnesota, United States
        • Contact Medtronic for exact location
    • South Carolina
      • Charleston, South Carolina, United States
        • Contact Medtronic for exact location

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • stable angina pectoris associated with reversible myocardial ischemia and significant coronary artery disease (CAD)
  • classified as Canadian Cardiovascular Society (CCS) angina class III or IV
  • refractory angina despite receiving optimal/maximal medical treatment
  • not a candidate for bypass surgery, angioplasty or stent

Exclusion Criteria:

  • not able to perform exercise treadmill testing
  • previously received therapeutic transcutaneous electrical nerve stimulation (TENS) (within 2 years) or any spinal cord stimulation (SCS)
  • has an implanted pacemaker/defibrillator (ICD)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary endpoint is total exercise time on a treadmill compared between treatment groups at six months.

Secondary Outcome Measures

Outcome Measure
Secondary outcome measures include exercise time to angina onset and improvement in angina symptoms and cardiovascular function.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedtronicNeuro

Investigators

  • Principal Investigator: Douglas Zipes, Indiana University School of Medicine
  • Principal Investigator: Nelson Svorkidal, Health Science Center, Winnipeg CANADA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (ACTUAL)

April 1, 2007

Study Completion (ACTUAL)

April 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (ESTIMATE)

September 20, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

August 30, 2010

Last Update Submitted That Met QC Criteria

August 26, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1659

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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