Using electrical stimulation to treat angina in patients without blocked arteries
The Novel Use of Transcutaneous Electrical Nerve Stimulation in Patients With Angina and Non-Obstructive Coronary Arteries: a Pilot Study
This study is testing if a treatment called TENS can help people with angina who don't have blocked arteries feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Catharina Ziekenhuis Eindhoven Academic / other |
| Locations | 1 site (Eindhoven, North Brabant) |
| Trial ID | NCT06401291 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of Transcutaneous Electrical Nerve Stimulation (TENS) in patients suffering from angina pectoris who do not have obstructive coronary artery disease (ANOCA). The study focuses on two specific types of ANOCA: microvascular angina (MVA) and vasospastic angina (VSA), both of which are associated with significant health risks and impaired quality of life. Participants will be selected based on specific criteria related to their angina symptoms and responses to medical therapy. The goal is to assess the effectiveness of TENS in alleviating symptoms and improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with persistent angina and no obstructive coronary artery disease, specifically those diagnosed with microvascular or vasospastic angina.
Not a fit: Patients who have both endotypes of angina or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive treatment option for patients suffering from angina without obstructive coronary artery disease.
How similar studies have performed: While the use of electrical stimulation for pain management is established, the specific application for ANOCA is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Angina and no obstructive coronary artery disease (ANOCA) (CCS class III or IV) * Microvascular angina (MVA): * FFR \> 0.8 * CFR \< 2.0 * IMR ≥ 25 * Vasospastic angina (VSA): * FFR \> 0.8 * CFR ≥ 2.0 * IMR \< 25 * During acetylcholine testing: ≥ 90% diameter reduction, angina pectoris and ischaemic ECG changes * Persisting angina pectoris despite optimal medical therapy (OMT) defined as: * MVA: Betablocker, calcium channel blocker, nicorandil and/or ivabradine (Important side note: ranolazine and trimetazidine cannot be prescribed in the Netherlands). * VSA: Calcium channel blocker, long-acting nitrate and/or nicorandil. In the maximum tolerated dose. If the patient is currently not using one of the medications due to side-effects, this should be clearly stated. * Age \> 18 years Exclusion Criteria: * Both endotypes (VSA and MVA) present based on CFT findings. * Inability to give informed consent * Inability to perform a 6-minute walking test * The presence of a cardiac implanted electronic device (CIED); pacemaker and/or Implantable Cardiac Defibrillator (ICD). Due to the risk of interference between TENS and CIED * Presence of a spinal cord stimulator for another indication such as complex regional pain syndrome, failed back surgery syndrome, etc.
Where this trial is running
Eindhoven, North Brabant
- Catharina Hospital — Eindhoven, North Brabant, Netherlands (Recruiting)
Study contacts
- Study coordinator: Inge Wijnbergen, MD, PhD
- Email: inge.wijnbergen@catharinaziekenhuis.nl
- Phone: +31402397000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.