An interventional study of Spinal Cord Stimulator in Refractory Angina Pectoris and Spinal Cord Stimulation, sponsored by Catharina Ziekenhuis Eindhoven. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-01.
Sponsored by Catharina Ziekenhuis Eindhoven · Not applicable, Interventional, and Treatment
There are a growing number of patients with refractory angina pectoris (RAP). RAP is defined as a 'chronic condition (> three months) characterized by diffuse coronary artery disease in the presence of proven ischemia, which is not amendable to a combination of medical therapy, angioplasty or coronary bypass surgery'. These patients are severely restricted in performing daily activities due to debilitating angina complaints, leading to a decreased quality of life.
Spinal cord stimulation (SCS) is a last resort treatment option for patients with RAP. SCS is a device with a lead located in the thoracic epidural space and an Implantable Pulse Generator (IPG) in the abdomen or buttock that provides neurostimulation. Four possible mechanisms explaining the beneficial effects of SCS on RAP have been described: reduction of pain perception, decreased sympathetic tone, reduced myocardial oxygen demand, and improved coronary microcirculatory blood flow.
Research into the effect of SCS on RAP up to date have mainly been observational studies, with only four placebo-controlled randomized controlled trials. All studies confirm that treatment with SCS leads to a reduction in the number of angina pectoris attacks. What is currently not clear, is whether there is a placebo effect as results vary between the studies. One study looked at the effect of SCS in patients with RAP on the reduction of ischemia (using MIBI-SPECT) with no control arm. After 12 months myocardial ischemia was reduced, but not after three months of treatment. Leading to the conclusion that the reduction is myocardial ischemia was not a direct effect of SCS, but rather due to better coronary collateralization.
The 2020 ESC guideline 'chronic coronary syndromes' mentions non-existing to promising levels of evidence with regard to treatment options in patients with RAP and concludes that SCS may be considered (Class IIB; level of evidence B). It concludes that 'larger RCTs are required to define the role of each treatment modality for specific subgroups, to decrease non-responder rates and ascertain benefit beyond potential placebo effects'.
The aim of the current randomized controlled trial (double-blind, cross-over, placebo-controlled, single center) is to determine if high density spinal cord stimulation, a paresthesia free form of stimulation, leads to a significant reduction in myocardial ischemia (using PET with Rubidium-82 as tracer) in patients with refractory angina pectoris.
All patients included in this study will receive an implanted spinal cord stimulator after a positive TENS treadmill outcome and proven ischemia using the imaging modality PET with Rubidium-82 as tracer. Using a cross-over design all patients will have a 6 month period with high density stimulation and 6 month period of no stimulation. Randomization will determine in which order the patient receives these treatments. Both the patient and the treating physicians are blinded for this randomization process. At baseline a 6-minute walking test, the Seattle Angina Questionnaire, the RAND-36 questionnaire, the NRS scale and the CCS class will be performed/filled out.
Cross-over takes place at 6 months (switch from high density stimulation to no stimulation or vice versa) prior to which the PET scan is repeated, as well as the 6-minute walking test, the Seattle Angina Questionnaire, the RAND-36 questionnaire, the NRS-scale and the CCS-class.
At the end of the study period (12 months) the PET scan is repeated, as well as the 6-minute walking test, the Seattle Angina Questionnaire, the RAND-36 questionnaire, the NRS-scale and the CCS-class.
519 studies on the registry are indexed under Angina Pectoris; 82 are open to participants now.
This study's planned enrollment of 72 is below the median of 123 across 336 interventional studies indexed under Angina Pectoris.
Browse Angina Pectoris studies →Catharina Ziekenhuis Eindhoven is the lead sponsor of 80 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Refractory Angina Pectoris:
Proven ischemia:
Exclusion Criteria:
Patients in this group will receive high density stimulation (parasthesia free form of stimulation) during the first 6 months of the study period. After 6 months cross-over will take place and patients will receive no stimulation during the final 6 months of the study period.
Device: Spinal Cord Stimulator
Patients in this group will receive no stimulation during the first 6 months of the study period. After 6 months cross-over will take place and patients will receive high density stimulation (parasthesia free form of stimulation) during the final 6 months of the study period.
Device: Spinal Cord Stimulator
All patients will receive an implanted spinal cord stimulator.
Also known as: Medtronic PrimeADVANCED™ SureScan® myStim & Vectris Compact™ SureScan MRI electrode
Myocardial ischaemia
The primary endpoint is the change in the percentage of myocardial ischaemia (% of left ventricular myocardium) measured using PET perfusion scan at the end of the six month period of HD stimulation compared to baseline.
Time frame: 6 months
Patient condition
Patient condition measured using the 6-minute walking test
Time frame: From date of randomization until six and twelve months later
Frequency of angina pectoris attacks
Frequency of angina pectoris attacks measured using the Seattle Angina Questionnaire; scale 0 - 100 with higher scores representing a better outcome.
Time frame: From date of randomization until six and twelve months later
Severity of angina pectoris attacks
Severity of angina pectoris attacks using the Numeric Rating Scale (NRS-scale); scale 0 - 10 with higher scores representing a worse outcome.
Time frame: From date of randomization until six and twelve months later
Grading of angina pectoris
Grading of angina pectoris using the Canadian Cardiovascular Society (CCS) class; grading scale of I - IV with higher scores representing worse outcome.
Time frame: From date of randomization until six and twelve months later
Frequency of short-acting nitroglycerin use
Frequency of short-acting nitroglycerin use measured using the Seattle Angina Questionnaire; scale 0 - 100 with higher scores representing a better outcome.
Time frame: From date of randomization until six and twelve months later
Quality of life outcome
Quality of life outcome measured using the RAND 36-Item Health Survery (RAND-36 questionnaire); scale 0 - 100 with higher scores representing a better outcome.
Time frame: From date of randomization until six and twelve months later
Hospital admissions due to acute coronary syndrome
Number of hospital admissions due to acute coronary syndrome (ACS)
Time frame: From date of randomization until six and twelve months later
Revascularization
Occurence of revascularization (CABG and/or PCI)
Time frame: From date of randomization until six and twelve months later
Emergency room visits due to angina pectoris
Number of presentations at the emergency room due to angina pectoris
Time frame: From date of randomization until six and twelve months later
Cardiovascular mortality
Occurence of cardiovascular mortality
Time frame: From date of randomization until six and twelve months later
Changes in regional and global myocardial blood flow and myocardial flow reserve
Changes in the regional and global myocardial blood flow and myocardial flow reserve measured using PET perfusion scan
Time frame: From date of randomization until six and twelve months later
Device infection
Number of device infections (lead and/or battery)
Time frame: From date of randomization until six and twelve months later
Device dislocation
Number of device dislocations (lead and/or battery)
Time frame: From date of randomization until six and twelve months later
Lead fractures
Number of lead fractures/breakages
Time frame: From date of randomization until six and twelve months later
Lead failure
Number of lead failures
Time frame: From date of randomization until six and twelve months later
Battery End of Life (EOL)
Number of battery End of Life (EOL)
Time frame: From date of randomization until six and twelve months later
Plan to share: Undecided
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Catharina Ziekenhuis Eindhoven