NL-OMON55130
Recruiting
Not Applicable
Efficacy of Spinal Cord Stimulation in patients with Refractory Angina Pectoris; a randomized controlled trial - SCRAP trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- refractory angina pectoris. End stage coronary artery disease
- Sponsor
- Catharina-ziekenhuis
- Enrollment
- 72
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
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; b\-blocker and/or calcium channel blocker, short\- and/or
- •long\-acting nitrate. If the patient doesn\*t use one of these groups of
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
Outcomes
Primary Outcomes
Not specified
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