Efficacy of Spinal Cord Stimulation in patients with Refractory Angina Pectoris; a randomized controlled trial

Recruiting

• Conditions: refractory angina pectoris. End stage coronary artery disease; 10011082

• Registration Number: NL-OMON55130
• Lead Sponsor: Catharina-ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 72

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; b-blocker and/or calcium channel blocker, 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 intervention 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 or older

Exclusion Criteria

- Acute coronary syndrome (ACS) during 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 (see Inclusion criteria for definition)
- 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 prior to spinal cord
stimulator implantation
- Inadequate paresthesia 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified