Angina Pectoris - Chest Pain
Conditions
Interventions
Implantation with a SCS defice with one or two lead(s) in the epidural space of
T1 to T4, active elctrodes depending on mapping of the painfull area, under
local anesthesia and sedation. Acetylcholi
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - age 18 to 90 of either sex - VSA is objectivated with a provocative acetylcholine test - mentally competent and able to fill in the questionnaires - refractory VSA defined as chest pain with a maximum tolerated dosage of calcium antagonists, long acting nitrates, and ACE for a minimum of three months - no procedures like PCI or CABG, nor instability of the clinical signs and symptoms of refractory angina in the previous three months - absence of obstructive coronary artery disease evident in a main coronary artery (diameter stenosis0.89, or FFR >0.80) - able to use the remote control of the SCS system
Exclusion criteria
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 - implanted pacemaker or ICD incompatible with SCS - indication for ongoing anticoagulation therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primairy endpoint is the *Seattle Angina Questionnaire* (SAQ) at month 1 and 3. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundairy endpoints are presentation at ER and patient satisfaction measured on a 11 point Numeric Rating Scale and quality of life with the EQ5D at month 1, 3 and 6 months, compared to baseline. Endpoints of the acetylcholine test are changes in coronary flow and coronary diameter compared to baseline. Added: Questionnaires 12 months after implant | — |
Countries
Netherlands
Outcome results
None listed