Using spinal cord stimulation to treat severe chest pain from refractory angina
Efficacy of Spinal Cord Stimulation in Patients With Refractory Angina Pectoris; a Randomized Controlled Trial
This study is testing whether spinal cord stimulation can help people with severe chest pain from refractory angina feel better when other treatments haven't worked.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Catharina Ziekenhuis Eindhoven Academic / other |
| Locations | 1 site (Eindhoven, Noord Brabant) |
| Trial ID | NCT04915157 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy of spinal cord stimulation (SCS) as a treatment for patients suffering from refractory angina pectoris, a chronic condition characterized by severe chest pain that does not respond to conventional therapies. The SCS device is implanted to provide neurostimulation, which may alleviate pain and improve quality of life through various mechanisms, including reduced pain perception and improved blood flow. Eligible patients will have stable angina pectoris and significant coronary artery disease that is not amenable to revascularization. The study aims to assess the impact of this last-resort treatment option on patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients with stable refractory angina pectoris who have not responded to optimal medical therapy and have significant coronary artery disease.
Not a fit: Patients with angina that can be managed through other medical or surgical interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from debilitating angina pectoris.
How similar studies have performed: Previous studies have shown promising results for spinal cord stimulation in managing chronic pain conditions, suggesting potential efficacy for refractory angina pectoris.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Refractory Angina Pectoris: * Stable angina pectoris CCS class III or IV, with a minimum of 5 episodes of angina pectoris over the course of one week, during a minimum period of three months prior to screening * Coronary angiogram (CAG) performed within the last 12 months showing significant coronary artery disease defined as at least one coronary artery stenosis of \>75% or 50 - 75% with proven ischaemia (see below), not suitable for revascularisation. Confirmed by one (or two in case of doubt) interventional cardiologist based on CAG images. * Optimal anti-anginal medication. Patients should at least use the maximal tolerable dose of a b-blocker, calcium channel blocker and short- and/or long-acting nitrate. If the patient doesn't use one of these groups of medication the reason (side-effects) should be clear. * Proven ischemia: * MIBI-SPECT: summed stress score (SSS) of at least 1, in combination with summed difference score (SDS) of at least 1 (1-4 mild ischaemia, \> 4 moderate to severe ischaemia). * FFR: \< 0.80, with no intervention options (determined by interventional cardiologist) * MRI perfusion: ≥ 1 segment of subendocardial hypoperfusion during stress perfusion, not present at rest and no matching fibrosis (using 16 segment AHA heart model) * PET: Semi-quantitative measurement: SSS score of at least 1, in combination with SDS score of at least 1 (1-4 mild ischaemia, \> 4 moderate to severe ischaemia). Quantitative measurement: reduced myocardial perfusion reserve. * No revascularisation (PCI and/or CABG) performed between ischaemia testing and study inclusion. * Age \> 18 years Exclusion Criteria: * Acute coronary syndrome (ACS) during the three month period prior to screening * Life expectancy less than 12 months * Inability to perform a 6-minute walking test * Inability to give informed consent * No proven ischemia * Spinal cord disease which could prevent correct positioning of the lead in the epidural space; to be determined by the anaesthesiologist performing the implantation * Anticoagulation therapy that cannot be stopped/bridged prior to spinal cord stimulator implantation * Inadequate paraesthesia coverage, during implantation, of the thoracic region where angina complaints are localized * Pregnancy * Mild Cognitive Impairment or dementia * Concomitant symptomatic valvular heart disease including severe aortic stenosis and/or regurgitation, severe mitral valve stenosis and/or regurgitation or severe tricuspid valve regurgitation.
Where this trial is running
Eindhoven, Noord Brabant
- Catharina Hospital — Eindhoven, Noord Brabant, Netherlands (Recruiting)
Study contacts
- Study coordinator: Inge Wijnbergen, MD, PhD
- Email: inge.wijnbergen@catharinaziekenhuis.nl
- Phone: 0031402397000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.