Refractory angina Circulatory System Angina pectoris
Conditions
Interventions
Participants will be randomised to receive either a spinal cord stimulator (SCS) with usual care or to receive usual care alone.
One group will therefore have a SCS implanted following a successful
Sponsors
South Tees Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Limiting angina despite optimal anti-angina therapy 2. Canadian Cardiovascular Society Functional Classification of Angina (CCS) Class III and IV 3. Angiographically documented coronary artery disease (CAD) 4. CAD not suitable for revascularisation in the opinion of the referring cardiologist/cardiothoracic surgeon 5. Satisfactory multidisciplinary assessment in accordance with British Pain Society (BPS) guidelines for SCS 6. Demonstrable ischaemia on functional testing
Exclusion criteria
Exclusion criteria: 1. Presence of pacemaker or implanted defibrillator that is incompatible with SCS 2. Patient refusal to participate in the study 3. Presence of co morbidity considered by the assessing clinician to overshadow the effect of the angina or render them an unsuitable candidate for neuromodulation (e.g. advanced spinal disease or deformity) 4. Poor cognitive ability 5. Ongoing anticoagulation therapy, where anticoagulants cannot be safely discontinued without jeopardising patient safety
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HRQoL as measured using the disease-specific measure the Seattle angina questionnaire (SAQ) UK version. We expect the SAQ to be the primary outcome in the definitive trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Intake of angina medications and angina attacks 2. Exercise capacity (at baseline and 6-months only) 3. Complications and adverse events 4. Healthcare utilisation (e.g. cardiac specific hospitalisations and primary care visits, management of complications/adverse events) 5. Generic measures HRQoL will be assessed using the EuroQol (EQ-5D) and Short Form -36 (SF-36) questionnaires | — |
Countries
United Kingdom
Outcome results
None listed