Spinal Cord Stimulation for Vasospastic Angina Pectoris - a Prospective Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 10
- Primary Endpoint
- Seattle Angina Questionnaire (SAQ)
Study Overview
Brief Summary
According to the 2020 Dutch guideline on chest pain (AP) without obstructive coronary artery disease, 70% of female and 30% of male patients undergoing a coronary angiogram (CAG), have no obstructive coronary artery disease.In the majority of patients the complaints are based on vascular dysfunction, including epicardial vascular spasms. For patients who are refractory to drug treatment, spinal cord stimulation (SCS) can be a treatment option. SCS is used for the treatment of refractory neuropathic and ischaemic pain. In recent studies the use of SCS is proven for refractory angina pectoris, but the group with refractory vasospastic angina pectoris (rVSA) predominantly seen in women with invalidating impairment of quality of life, is overlooked, as no evidence of obstruction is found at CAG. With this pilot study the investigators hypothesize that SCS is effective in reducing the number and intensity of angina attacks, reducing nitrate use, reducing inhospital treatment and ER presentations, thereby reducing medical costs, and above all, increasing quality of life.
Detailed Description
Rationale:
Of the patients undergoing a coronary angiogram because of chest pain (AP), 67% of female and 33% of male patients have no obstructive coronary artery disease. In the majority of patients (59-89%) the complaints are based on vascular dysfunction, including epicardial vascular spasms (EVS). For patients who are refractory to drug treatment, spinal cord stimulation (SCS) can be a treatment option. SCS is used for the treatment of refractory neuropathic and ischaemic pain. In recent studies the use of SCS is proven effective for refractory angina pectoris, but the group with refractory vasospastic angina pectoris (rVSA), predominantly seen in women with invalidating impairment of quality of life, is overlooked, as no evidence of obstruction is found at CAG. With this study the investigators hypothesize that SCS is effective in reducing the number and intensity of angina attacks, reducing nitrate use, reducing inhospital treatment and ER presentations, thereby reducing medical costs, and above all, increasing quality of life.
Objective: the main objective of this study is to evaluate the clinical effects of SCS on the number and intensity of VSA attacks. Secondary objective is to objectivate the effects of SCS on coronary spasms during the provocative acetylcholine test, and assess medical costs, patient satisfaction and quality of life.
Study design: prospective study in two phases. Phase 1: evaluation of clinical effectiveness. Phase 2: evaluation of SCS on vascular spasms during acetylcholine provocation test.
Study population: 10 patients with refractory AP due to epicardial vascular spasms.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •VSA is objectivated with a provocative acetylcholine test
- •mentally competent and able to fill in the questionnaires
- •refractory VSA defined as disabling chest pain with a maximum tolerated dosage of calcium antagonists, long acting nitrates, angiotensin converting enzyme inhibitors for a minimum of three months
- •absence of obstructive coronary artery disease evident in a main coronary artery (diameter stenosis<50%, Instant Flow Reserve (IFR) >0.89, or Fractional Flow reserve (FFR) >0.80)
- •able to use the remote control of the SCS system
Exclusion Criteria
- •inability to visit the outpatient department for the follow-up visits
- •unable to provide informed consent
- •myocardial infarction in the previous three months
- •procedures like percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), nor instability of the clinical signs and symptoms of refractory angina in the previous three months
- •implanted pacemaker or implantable cardioverter-defibrillator (ICD) incompatible with SCS
- •indication for ongoing anticoagulation therapy
- •pregnant women and those who are breastfeeding
Outcomes
Primary Outcomes
Seattle Angina Questionnaire (SAQ)
Time Frame: baseline (before implant) - 1 month after implant - 3 months after implant
For patients with coronary artery disease, the Seattle Angina Questionnaire (SAQ) has emerged as the most commonly used measure of disease-specific health status to quantify patients' symptoms of angina and the extent to which their angina affects their functioning and quality of life. Scores of 0 to 30 translate to daily angina, 31 to 60 to weekly angina, 61 to 99 to monthly angina, and 100 to no angina.
Secondary Outcomes
- Euroquol Quality of Life questionnaire (EQ5D-5L)(baseline (before implant) -1 month after implant - 3 months after implant)
- Complications and side effects(through study completion, an average of 6 months)
- Patient satisfaction - Numeric Rating Scale (NRS) 0-10(1 month and 3 months after implant)
- Acetylcholine provocation test during coronary angiogram(6 months after implant)
Investigators
Frank Wille, MD
Principal Investigator
Amsterdam UMC, location VUmc