Angina PectorisPhase 4NCT00121654
Spinal Cord Stimulation (SCS) in Refractory Angina
A Phase 4 study testing Spinal cord stimulation in people with Angina Pectoris, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
The study aims at assessing safety and efficacy of Spinal Cord Stimulation (SCS) for the treatment of refractory angina pectoris in a single blind, prospective, multicenter study. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Angina Pectoris
- What is being tested?
- Spinal cord stimulation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2005to Dec 2009
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable angina pectoris refractory to optimal medical therapy, with at least 10 angina episodes in the three weeks previous SCS implant;
- Documentation of coronary artery disease and reversible myocardial ischaemia;
- Patient is not a candidate for or refuses surgical or percutaneous coronary revascularization;
- Availability for follow-up visits;
- Written informed consent.
Who cannot join
- Severe spinal cord diseases that prevent the catheter positioning in the epidural space;
- No paresthesic coverage of angina pain area during SCS;
- Unstable angina pectoris;
- Female patients in fertile age;
- Enrolment in other studies;
- Need for anticoagulant therapy;
- Patients needing diathermy treatment;
- Life expectancy <12 months.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto di Cardiologia - Università Cattolica del Sacro Cuore
Roma, 00168
Gaetano A Lanza, MD, +390630154187, g.a.lanza@rm.unicatt.it
About this study
Official title: Randomized Study on SCS for the Treatment of Refractory Angina Pectoris
The study aims at assessing safety and efficacy of Spinal Cord Stimulation (SCS) for the treatment of refractory angina pectoris in a single blind, prospective, multicenter study.
Sixty patients with refractory angina with new SCS device implantation will be randomized to one of three treatment groups:
- paresthesic SCS;
- subliminal SCS;
- low (non effective) stimulation (control).
Clinical follow-up will be done at 1 and 3 months. Control group patients will then be randomized to paresthesic SCS or subliminal SCS for another 3 months and the 2 groups will be reassessed at 6 months.
Read the detailed description
Aim of the study is to assess safety and efficacy of Spinal Cord Stimulation (SCS) for the treatment of refractory angina pectoris in a single blind, prospective, multicenter study. The study also assesses whether subliminal SCS may be as effective as paresthesic SCS in these patients.
Sixty consecutive patients with refractory angina with a new SCS device implantation will be randomized to one of three treatment groups:
- paresthesic SCS (group 1);
- subliminal SCS (75-80% of paresthesic threshold; group 2);
- low stimulation, consisting of an hour of SCS a day at 0.05 mV intensity, which does not have any significant stimulator effect (sham stimulation, group 3).
Study Procedure
Medical history, clinical data, drug therapy, Angina Canadian Cardiovascular Society (CCS) classification, Seattle Angina Questionnaire (SAQ), quality of life estimation by EuroQoL scale, detailed evaluation of angina attacks (frequency, intensity, duration of episodes; nitrates assumption) according to a structured diary, number of hospitalizations, emergency room (ER) admissions and cardiological visits in the previous 6 months and treadmill exercise stress test results will be obtained at the baseline visit.
Patients fulfilling inclusion criteria will undergo SCS implant. During the implant, stimulation tests will be performed to check paresthesic coverage of angina pain chest area.
Patients with adequate paresthesias will be randomized to one of the 3 groups. Follow-up visits will be performed at 1, 3, 6, and 12 months after the SCS implant. Drug therapy will not be changed at least during the first 3 months.
Patients assigned to group 2 (subliminal SCS) and those assigned to group 3 (sham SCS) will be blinded about the assigned treatment.
After the 3 months group 3, patients will be randomized to group 1 or group 2 and reassessed at 6-month follow-up (comparison between paresthesic versus subliminal SCS).
The controlled study will end at the 6-month follow-up, when each investigator will decide for the best stimulation for individual patients. Every patient will then be followed until 12 months from SCS implant.
Clinical assessment will be done at each follow-up visit. Exercise stress test results will be repeated at 3-, 6- and 12-month follow-up visits.
- Conditions
- Angina Pectoris
- Being tested
- Spinal cord stimulation
- Keywords
- Angina pectoris, Spinal cord stimulation, 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 stimulationDevice
Under sterile conditions and local anesthesia, the epidural space is punctured at the level of T5-T6 and a quadripolar electrode catheter is introduced and advanced under X-ray control into the epidural space. A suitable position for the electrode catheter is sought for, corresponding to the site where a prickling sensation (paresthesia) is felt and covers the area of radiation of angina pain under neurostimulation. The electrode catheter is connected to an internal pulse generator placed in a subcutaneous abdominal or gluteal pocket through an extension lead connected to the electrode by subcutaneous tunneling.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | paresthesic SCS Receives: Device: Spinal cord stimulation |
| 2 | Active comparator | subliminal SCS (75-80% of paresthesic threshold) Receives: Device: Spinal cord stimulation |
| 3 | Sham comparator | low stimulation, consisting of an hour of SCS a day at 0.05 mV intensity, which does not have any significant stimulator effect (sham stimulation) Receives: Device: Spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of angina symptoms
Measured: 1, 3, 6 and 12 months
improvement of quality of life
Measured: 1, 3, 6 and 12 months
Secondary outcomes (2)
Improvement of exercise induced myocardial ischemia
Measured: 3, 6 and 12 months
evaluation of adverse events and complications
Measured: 0, 1, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study startJul 2005
- Primary completionDec 2008
- Study completionDec 2009 (estimated)
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.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Investigators
- Gaetano A Lanza, MD, Principal investigator, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00121654
- Sponsor's protocol ID
- ITA-SCS1
- Status last verified
- Mar 2009
- First submitted
- 14 Jul 2005
- Last updated
- 10 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study on SCS for the Treatment of Refractory Angina Pectoris
- ClinicalTrials.gov ID
- NCT00121654
- Acronym / sponsor ID
- ITA-SCS1
- Conditions
- Angina Pectoris
- Keywords
- Angina pectoris, Spinal cord stimulation, Refractory angina pectoris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2009 (estimated)
- First posted
- 21 Jul 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 study aims at assessing safety and efficacy of Spinal Cord Stimulation (SCS) for the treatment of refractory angina pectoris in a single blind, prospective, multicenter study.
Sixty patients with refractory angina with new SCS device implantation will be randomized to one of three treatment groups:
- paresthesic SCS;
- subliminal SCS;
- low (non effective) stimulation (control).
Clinical follow-up will be done at 1 and 3 months. Control group patients will then be randomized to paresthesic SCS or subliminal SCS for another 3 months and the 2 groups will be reassessed at 6 months.
Detailed description
Aim of the study is to assess safety and efficacy of Spinal Cord Stimulation (SCS) for the treatment of refractory angina pectoris in a single blind, prospective, multicenter study. The study also assesses whether subliminal SCS may be as effective as paresthesic SCS in these patients.
Sixty consecutive patients with refractory angina with a new SCS device implantation will be randomized to one of three treatment groups:
- paresthesic SCS (group 1);
- subliminal SCS (75-80% of paresthesic threshold; group 2);
- low stimulation, consisting of an hour of SCS a day at 0.05 mV intensity, which does not have any significant stimulator effect (sham stimulation, group 3).
Study Procedure
Medical history, clinical data, drug therapy, Angina Canadian Cardiovascular Society (CCS) classification, Seattle Angina Questionnaire (SAQ), quality of life estimation by EuroQoL scale, detailed evaluation of angina attacks (frequency, intensity, duration of episodes; nitrates assumption) according to a structured diary, number of hospitalizations, emergency room (ER) admissions and cardiological visits in the previous 6 months and treadmill exercise stress test results will be obtained at the baseline visit.
Patients fulfilling inclusion criteria will undergo SCS implant. During the implant, stimulation tests will be performed to check paresthesic coverage of angina pain chest area.
Patients with adequate paresthesias will be randomized to one of the 3 groups. Follow-up visits will be performed at 1, 3, 6, and 12 months after the SCS implant. Drug therapy will not be changed at least during the first 3 months.
Patients assigned to group 2 (subliminal SCS) and those assigned to group 3 (sham SCS) will be blinded about the assigned treatment.
After the 3 months group 3, patients will be randomized to group 1 or group 2 and reassessed at 6-month follow-up (comparison between paresthesic versus subliminal SCS).
The controlled study will end at the 6-month follow-up, when each investigator will decide for the best stimulation for individual patients. Every patient will then be followed until 12 months from SCS implant.
Clinical assessment will be done at each follow-up visit. Exercise stress test results will be repeated at 3-, 6- and 12-month follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Spinal cord stimulationparesthesic SCS |
| 2 | Active comparator | Device: Spinal cord stimulationsubliminal SCS (75-80% of paresthesic threshold) |
| 3 | Sham comparator | Device: Spinal cord stimulationlow stimulation, consisting of an hour of SCS a day at 0.05 mV intensity, which does not have any significant stimulator effect (sham stimulation) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Stable angina pectoris refractory to optimal medical therapy, with at least 10 angina episodes in the three weeks previous SCS implant;
- Documentation of coronary artery disease and reversible myocardial ischaemia;
- Patient is not a candidate for or refuses surgical or percutaneous coronary revascularization;
- Availability for follow-up visits;
- Written informed consent.
Key exclusion criteria (8 listed)
- Severe spinal cord diseases that prevent the catheter positioning in the epidural space;
- No paresthesic coverage of angina pain area during SCS;
- Unstable angina pectoris;
- Female patients in fertile age;
- Enrolment in other studies;
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 stimulationUnder sterile conditions and local anesthesia, the epidural space is punctured at the level of T5-T6 and a quadripolar electrode catheter is introduced and advanced under X-ray control into the epidural space. A suitable position for the electrode catheter is sought for, corresponding to the site where a prickling sensation (paresthesia) is felt and covers the area of radiation of angina pain under neurostimulation. The electrode catheter is connected to an internal pulse generator placed in a subcutaneous abdominal or gluteal pocket through an extension lead connected to the electrode by subcutaneous tunneling. | Device | 1, 2, 3 |
Primary outcome
Reduction of angina symptoms
Time frame: 1, 3, 6 and 12 months
improvement of quality of life
Time frame: 1, 3, 6 and 12 months
2 secondary outcomes
Improvement of exercise induced myocardial ischemia
Time frame: 3, 6 and 12 months
evaluation of adverse events and complications
Time frame: 0, 1, 3, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2009.
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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.
Gaetano A Lanza, MD principal investigator
Catholic University of the Sacred Heart
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 in people with Angina Pectoris, run by Catholic University of the Sacred Heart at 1 site in Italy.
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 10 Mar 2009. 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 Italy. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gaetano A Lanza, MD (+390630154187, g.a.lanza@rm.unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of angina symptoms (time frame: 1, 3, 6 and 12 months). The study lists 2 primary outcomes in all. 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 10 Mar 2009.