Status:
UNKNOWN
SCS for Vasospastic Angina Vasospastic Angina Pectoris - a Prospective Study
Lead Sponsor:
Amsterdam UMC, location VUmc
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Angina Pectoris; Angiospastic
Eligibility:
All Genders
18-90 years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06176391
Start Date
January 2 2024
End Date
December 31 2024
Last Update
December 19 2023
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