Angina PectorisPhase 3STARTSTIMNCT00200070
Neurostimulation to Treat Refractory Angina Pectoris Pain
A Phase 3 study testing Spinal Cord Stimulation in people with Angina Pectoris, run by MedtronicNeuro at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina Pectoris
- What is being tested?
- Spinal Cord Stimulation
- Type of treatment
- Medical device
- How many people
- 228 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Dec 2002to Apr 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States6 sites
Contact Medtronic for Exact Location
Boston, Massachusetts
Contact Medtronic for Exact Location
Charleston, South Carolina
Contact Medtronic for Exact Location
Gainesville, Florida
Contact Medtronic for Exact Location
Indianapolis, Indiana
Contact Medtronic for Exact Location
Minneapolis, Minnesota
Contact Medtronic for Exact Location
Rochester, Minnesota
Canada2 sites
Contact Medtronic for Exact Location
Ottawa, Ontario
Contact Medtronic for Exact Location
Winnipeg, Manitoba
About this study
Official title: 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.
- Conditions
- Angina Pectoris
- Being tested
- Spinal Cord Stimulation
- Keywords
- Angina Pectoris Pain
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord StimulationDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is total exercise time on a treadmill compared between treatment groups at six months.
Secondary outcomes (1)
Secondary outcome measures include exercise time to angina onset and improvement in angina symptoms and cardiovascular function.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startDec 2002
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Angina PectorisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 228 participants
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Douglas Zipes, Principal investigator, Indiana UniversityNelson Svorkidal, Principal investigator, Health Science Center, Winnipeg CANADA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200070
- Sponsor's protocol ID
- 1659
- Acronym
- STARTSTIM
- Status last verified
- Aug 2010
- First submitted
- 12 Sep 2005
- Last updated
- 30 Aug 2010
- Results posted
- No
Publications
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.
PubMed 22494013
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STARTSTIM - Stimulation Therapy for Angina Refractory To Standard Treatments, Interventions and Medications
- ClinicalTrials.gov ID
- NCT00200070
- Acronym / sponsor ID
- STARTSTIM / 1659
- Conditions
- Angina Pectoris
- Keywords
- Angina Pectoris Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 228 participants
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Cord Stimulation | Device | – |
Primary outcome
The primary endpoint is total exercise time on a treadmill compared between treatment groups at six months.
1 secondary outcome
Secondary outcome measures include exercise time to angina onset and improvement in angina symptoms and cardiovascular function.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2010.
- Derived from this study: PubMed 22494013Zipes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Zipes principal investigator
Indiana University
Nelson Svorkidal principal investigator
Health Science Center, Winnipeg CANADA
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Spinal Cord Stimulation in people with Angina Pectoris, run by MedtronicNeuro at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is total exercise time on a treadmill compared between treatment groups at six months.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00200070, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2010.