Transcutaneous Electrical Nerve Stimulation in Patients With Angina and Non-Obstructive Coronary Arteries

Launched by CATHARINA ZIEKENHUIS EINDHOVEN · May 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a potential new treatment for patients who have angina (chest pain) but do not have blocked coronary arteries, a condition known as ANOCA. There are two types of ANOCA: microvascular angina, which involves problems with the tiny blood vessels in the heart, and vasospastic angina, where the larger arteries can spasm and restrict blood flow. The trial will investigate whether using transcutaneous electrical nerve stimulation (TENS) for one month can help reduce chest pain and improve the quality of life for these patients.

To be eligible for this study, participants must be over 18 years old and experience ongoing angina despite receiving standard treatment. Specifically, they need to have been diagnosed with either microvascular angina or vasospastic angina. Participants can expect to receive TENS therapy during the study to see if it helps relieve their symptoms. This trial is currently recruiting and aims to provide new insights into managing chest pain for those with ANOCA.

Gender

ALL

Eligibility 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.