Angina PectorisPhase 4NCT00157742
Comparison of SCS and PMR in Patients With Refractory Angina Pectoris
A Phase 4 study testing Spinal Cord Stimulation (SCS) and Percutaneous Myocardial Laser Revascularisation (PMR) in people with Angina Pectoris, run by Medtronic at 1 site in United Kingdom.
Trial summary
Randomised trial of Spinal Cord Stimulation (SCS) and Percutaneous Myocardial Laser Revascularisation (PMR) in patients with Refractory Angina Pectoris. Hypothesis: difference in exercise tolerance at 12 months between SCS and PMR 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 (SCS) and Percutaneous Myocardial Laser Revascularisation (PMR)
- Type of treatment
- Surgery or procedure
- How many people
- 66 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2000to Jan 2007
- Phase
- Phase 4
- 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
- Patient limiting angina (CCS III or IV) despite maximally tolerated medical therapy
- Documented coronary artery disease (within the last 9 months prior baseline), which is unsuitable for conventional revascularisation techniques
- Patient has documented reversible ischemia on nuclear scan (Tc-99 sestamibi)
- Patient is limited in daily activities, primarily exercice capability, by their angina pain
- Age 18 or older
- Patient must understand the therapy and give informed consent
- Patient must be available for appropriate follow-up times for length of Study
- Non pregnant woman
Who cannot join
- Not candidate for surgical implantation of SCS and/or not for PMR and/or unable to use SCS device appropriately for treatment
- Patient who has had one or more major cardiac events within 2 months
- Patient with myocardial wall thickness< 8 mm in the ischaemic area to be treated as verified by echocardiography
- Patient with extensive peripheral vascular disease that precludes vascular access required for PMR
- Patient on intravenous therapy to control their symptoms
- Patient who is unlikely to survive for more than 12 months due to non cardiac condition e.g.malignancy
Show all 16Show fewer
- patient who has other diseases that are considered of greater clinical significance than the angina pectoris that would impact the ability of the clinician to adequately assess the incremental effects of the trial treatment
- Patient with ejection fraction of less than 30 % as verified by echocardiography
- Patient with cause of angina other than coronary artery disease (e.g. syndrome "X" patient)
- Patient who are unable to perform treadmill exercice test per protocol
- Patient who was previously enrolled in this study, or is currently in another clinical study, which will interfere with this protocol
- Patient who has has SCS , a TMLR or PMR procedure in the past
- Patient with an implanted pacemaker or defibrillator
- Patient who has medical conditions which may require Magnetic resonance Imaging (MRI)
- Patient with history of dementia or other persisting mental disorders significantly interfering with ability to cooperate or comply with the requirements of the study or comprehend informed consent
- Patient with history of Alcohol og Drug abuse
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Papworth Hospital
Papworth Everard, Cambridge, CB3 8RE
About this study
Official title: An Open Single-Centre Parallel Randomised Trial of Spinal Cord Stimulation (SCS) and Percutaneous Myocardial Revascularisation (PMR) in Patients With Refractory Angina Pectoris
Randomised trial of Spinal Cord Stimulation (SCS) and Percutaneous Myocardial Laser Revascularisation (PMR) in patients with Refractory Angina Pectoris.
Hypothesis: difference in exercise tolerance at 12 months between SCS and PMR
Read the detailed description
The purpose of this open, parallel, single-center prospective, randomised controlled trial is to compare two treatments: Spinal Cord Stimulation (SCS) and Percutaneous Myocardial Laser Revascularisation (PMR) and assess their use and longer term effect in patients with Refractory Angina Pectoris.
- Conditions
- Angina Pectoris
- Being tested
- Spinal Cord Stimulation (SCS), Percutaneous Myocardial Laser Revascularisation (PMR)
- Keywords
- Angina Pectoris, Spinal Cord Stimulation (SCS), Percutaneous Myocardial Revascularisation (PMR), Refractory Angina Pectoris
- 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 Stimulation (SCS)Procedure or surgery
Percutaneous Myocardial Laser Revascularisation (PMR)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in total exercice time following SCS compared to PMR at 12 months
Secondary outcomes (7)
Angina measured by the CCS class and the patients subjectives observations
Morbidity/Mortality
Quality of life
Medication consumption
Difference in myocardial perfusion scanning
Myocardial ischemia during exercise treadmill testing
Safety profiles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startSep 2000
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina PectorisStudies of the same condition, open and under way.
- More trials run by MedtronicThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants
Sponsor and investigators
- Lead sponsor
- Medtronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Peter Schofield, MD, Principal investigator, Papworth Hospital, NHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00157742
- Sponsor's protocol ID
- SPIRIT
- Status last verified
- Sep 2005
- First submitted
- 9 Sep 2005
- Last updated
- 16 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Single-Centre Parallel Randomised Trial of Spinal Cord Stimulation (SCS) and Percutaneous Myocardial Revascularisation (PMR) in Patients With Refractory Angina Pectoris
- ClinicalTrials.gov ID
- NCT00157742
- Acronym / sponsor ID
- SPIRIT
- Conditions
- Angina Pectoris
- Keywords
- Angina Pectoris, Spinal Cord Stimulation (SCS), Percutaneous Myocardial Revascularisation (PMR), Refractory Angina Pectoris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 66 participants
- Lead sponsor
- MedtronicIndustry (pharma, biotech, devices)
- Study start
- Sep 2000
- Study completion
- Jan 2007
- First posted
- 12 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.
Randomised trial of Spinal Cord Stimulation (SCS) and Percutaneous Myocardial Laser Revascularisation (PMR) in patients with Refractory Angina Pectoris.
Hypothesis: difference in exercise tolerance at 12 months between SCS and PMR
Detailed description
The purpose of this open, parallel, single-center prospective, randomised controlled trial is to compare two treatments: Spinal Cord Stimulation (SCS) and Percutaneous Myocardial Laser Revascularisation (PMR) and assess their use and longer term effect in patients with Refractory Angina Pectoris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient limiting angina (CCS III or IV) despite maximally tolerated medical therapy
- Documented coronary artery disease (within the last 9 months prior baseline), which is unsuitable for conventional revascularisation techniques
- Patient has documented reversible ischemia on nuclear scan (Tc-99 sestamibi)
- Patient is limited in daily activities, primarily exercice capability, by their angina pain
- Age 18 or older
Key exclusion criteria (16 listed)
- Not candidate for surgical implantation of SCS and/or not for PMR and/or unable to use SCS device appropriately for treatment
- Patient who has had one or more major cardiac events within 2 months
- Patient with myocardial wall thickness< 8 mm in the ischaemic area to be treated as verified by echocardiography
- Patient with extensive peripheral vascular disease that precludes vascular access required for PMR
- Patient on intravenous therapy to control their symptoms
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 (SCS) | Procedure or surgery | – |
| Percutaneous Myocardial Laser Revascularisation (PMR) | Procedure or surgery | – |
Primary outcome
Improvement in total exercice time following SCS compared to PMR at 12 months
7 secondary outcomes
Angina measured by the CCS class and the patients subjectives observations
Morbidity/Mortality
Quality of life
Medication consumption
Difference in myocardial perfusion scanning
Myocardial ischemia during exercise treadmill testing
Safety profiles
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 16 Dec 2005.
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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.
Peter Schofield, MD principal investigator
Papworth Hospital, NHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Spinal Cord Stimulation (SCS) and Percutaneous Myocardial Laser Revascularisation (PMR) in people with Angina Pectoris, run by Medtronic at 1 site in United Kingdom.
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 8 inclusion and 16 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 16 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Improvement in total exercice time following SCS compared to PMR at 12 months. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2005.