SCS for Vasospastic Angina Vasospastic Angina Pectoris - a Prospective Study (NCT06176391) | Clinical Trial Compass
UnknownNot Applicable
SCS for Vasospastic Angina Vasospastic Angina Pectoris - a Prospective Study
10 participantsStarted 2024-01-02
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Seattle Angina Questionnaire (SAQ)
Timeframe: baseline (before implant) - 1 month after implant - 3 months after implant