Spinal Cord Stimulation for Vasospastic Angina Pectoris - a prospective study

Conditions: Angina Pectoris - Chest Pain
10011082

Registration Number: NL-OMON53627

Lead Sponsor: Amsterdam UMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 10

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 stenosis<50%, iFR>0.89, or 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
- implanted pacemaker or ICD incompatible with SCS
- indication for ongoing anticoagulation therapy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primairy endpoint is the Seattle Angina Questionnaire (SAQ) at month 1 and 3. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundairy endpoints are presentation at ER and patient satisfaction measured<br />on a 11 point Numeric Rating Scale and quality of life with the EQ5D at month<br />1, 3 and 6 months, compared to baseline. Endpoints of the acetylcholine test<br />are changes in coronary flow and coronary diameter compared to baseline. </p>