Neurostimulation to Treat Refractory Angina Pectoris Pain | NCT00200070

Studies
Neurostimulation to Treat Refractory Angina Pectoris Pain

NCT00200070

Sponsor

MedtronicNeuro

Status

Terminated

Last Update Posted

Aug 30, 2010Estimated

Enrollment

228

Phase

Phase 3

Conditions

Angina Pectoris

Interventions

Spinal Cord Stimulation

Countries

United States
Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2002

Primary Completion Date

Apr 2007Actual

Completion Date

Apr 2007Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 26, 2010

Last Update Posted Date

Aug 30, 2010Estimated

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

228

Name	Type	Description	Arm Group Labels	Other Names
Spinal Cord Stimulation	Device

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Douglas Zipes	Indiana University	Principal Investigator
Nelson Svorkidal	Health Science Center, Winnipeg CANADA	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Contact Medtronic for Exact Location		Gainesville	Florida		United States
Contact Medtronic for Exact Location

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22494013	Derived	Zipes DP, Svorkdal N, Berman D, Boortz-Marx R, Henry T, Lerman A, Ross E, Turner M, Irwin C. Spinal cord stimulation therapy for patients with refractory angina who are not candidates for revascularization. Neuromodulation. 2012 Nov-Dec;15(6):550-8; discussion 558-9. doi: 10.1111/j.1525-1403.2012.00452.x. Epub 2012 Apr 11.

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D026741	Physical Therapy Modalities
D012046	Rehabilitation