Status:
UNKNOWN
Efficacy of Spinal Cord Stimulation in Patients With Refractory Angina Pectoris
Lead Sponsor:
Catharina Ziekenhuis Eindhoven
Conditions:
Refractory Angina Pectoris
Spinal Cord Stimulation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04915157
Start Date
December 21 2021
End Date
June 1 2025
Last Update
September 1 2023
Active Locations (1)
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1
Catharina Hospital
Eindhoven, North Brabant, Netherlands, 5623EJ