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临床试验/NL-OMON56491
NL-OMON56491尚未招募不适用

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

Catharina-ziekenhuis0 个研究点目标入组 20 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • - 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.
  • 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

排除标准

  • - 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.

研究者

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