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Clinical Trials/NL-OMON56491
NL-OMON56491
Not yet recruiting
Not Applicable

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

Catharina-ziekenhuis0 sites20 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Catharina-ziekenhuis
Enrollment
20
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • \- Angina and no obstructive coronary artery disease (ANOCA) (CCS class III or
  • 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.

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.

Outcomes

Primary Outcomes

Not specified

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