MedTrace Logo

SCS for Vasospastic Angina Vasospastic Angina Pectoris - a Prospective Study

NCT06176391 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-12-19

No results posted yet for this study

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.

Conditions

  • Angina Pectoris; Angiospastic

Interventions

DEVICE

Spinal Cord Stimulation

Single lead placement in the posterior thoracic epidural space (T1-T4) connected to a subcutaneous battery

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Amsterdam UMC, location VUmc

    lead OTHER

Principal Investigators

  • Markus Hollmann, MD, PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-02
Primary Completion
2024-10-31
Completion
2024-12-31
FDA Device
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06176391 on ClinicalTrials.gov