The Novel Use of Transcutaneous Electrical Nerve Stimulation in Patients with Angina and Non-Obstructive Coronary Arteries; a Pilot Study

• Conditions: Microvascular coronary artery disease. Angina with non-obstructive coronary arteries; 10011082

• Registration Number: NL-OMON56491
• Lead Sponsor: Catharina-ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

- Angina and no obstructive coronary artery disease (ANOCA) (CCS class III or
IV)
o Microvascular angina (MVA): FFR > 0.8, CFR < 2.0, IMR >= 25
o Vasospastic angina (VSA): FFR > 0.8, CFR >= 2.0, IMR < 25 and during
acetylcholine testing: >=
90% diameter reduction, Angina pectoris & Ischaemic ECG changes.
- Persisting angina pectoris despite optimal medical therapy (OMT) defined as:
o MVA: Betablocker, calcium channel blocker, nicorandil and/or ivabradine
(Important side note:
ranolazine and trimetazidine cannot be prescribed in the Netherlands).
o 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)
o Pacemaker
o 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified