Efficacy of Spinal Cord Stimulation in Patients With Refractory Angina Pectoris

Launched by CATHARINA ZIEKENHUIS EINDHOVEN · May 31, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating whether a treatment called spinal cord stimulation (SCS) can help patients with refractory angina pectoris (RAP), a severe chest pain condition that doesn’t improve with standard medical treatments or surgeries. The study aims to see if a specific type of SCS, which does not cause tingling sensations, can significantly reduce heart muscle strain (myocardial ischemia) in these patients. Participants will undergo a 12-month process where they will receive SCS for six months and then have a six-month period without stimulation, helping researchers understand the effects of the treatment compared to no treatment at all.

To be eligible for this trial, participants must be at least 18 years old and have experienced significant chest pain (CCS class III or IV) with at least five episodes per week for three months. They should also have evidence of severe coronary artery disease that is not suitable for surgery. Participants will undergo various tests, including a walking test and imaging studies to measure heart function and pain. Throughout the study, both patients and doctors will not know whether they are receiving the treatment or a placebo, ensuring the results are unbiased. This trial is crucial for understanding how effective spinal cord stimulation can be for patients suffering from this debilitating condition.

Gender

ALL

Eligibility 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.