An interventional study of Transcutaneous Electrical Nerve Stimulation in Microvascular Angina and Vasospastic Angina, sponsored by Catharina Ziekenhuis Eindhoven. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-06.
Sponsored by Catharina Ziekenhuis Eindhoven · Not applicable, Interventional, and Treatment
In patients with angina pectoris undergoing a coronary angiography (CAG) up to 40% do not have obstructive coronary artery disease (CAD). The majority of patients with no obstructive CAD are women with a frequency of up to 70% compared to 50% in men. These patients are diagnosed as having angina and non-obstructive coronary arteries (ANOCA). There are two endotypes of ANOCA. The first endotype is microvascular angina (MVA) caused by a combination of structural microcirculatory remodelling and functional arteriolar dysregulation, also called coronary microvascular dysfunction (CMD). The second endotype is vasospastic angina (VSA) caused by epicardial coronary artery spasm that occurs when a hyper-reactive epicardial coronary segment is exposed to a vasoconstrictor stimulus. Both endotypes of ANOCA are associated with significantly greater one-year risk of myocardial infarction (MI) and all-cause mortality, have a significantly impaired quality of life and have a high health care resource utilisation.
The current treatment for ANOCA consists of three aspects. The first aspect is managing lifestyle factors such as weight management, smoking cessation and exercise. The second aspect is managing known cardiovascular risk factors such as hypertension, dyslipidaemia and diabetes mellitus. And the third aspect is antianginal medication. In both endotypes ACE inhibitors or angiotensin II receptor blockers should be considered. In MVA the antianginal medication that can be used are betablocker, calcium channel blocker, nicorandil, ranolazine, ivabradine and/or trimetazidine. In VSA calcium channel blocker, long-acting nitrate and/or nicorandil can be initiated as antianginal therapy. Despite these treatment option approximately 25% of ANOCA patients have refractory angina symptoms.
A possible treatment modality for ANOCA patients with refractory angina pectoris is spinal cord stimulation (SCS) or transcutaneous electrical nerve stimulation (TENS). Previous research (in patients with cardiac syndrome X) has shown that SCS improves time until angina and ischaemia, significantly less angina and an improvement in quality of life. These findings suggest that SCS and/or TENS could be a possible treatment modality for patients with ANOCA.
The aim of this pilot study is to investigate whether treatment with TENS during a one month period leads to a significant reduction of angina pectoris and therefore a significant improvement in quality of life in patients with proven ANOCA, encompassing both endotypes (MVA and VSA).
519 studies on the registry are indexed under Angina Pectoris; 82 are open to participants now.
This study's planned enrollment of 20 is below the median of 123 across 336 interventional studies indexed under Angina Pectoris.
Browse Angina Pectoris studies →Catharina Ziekenhuis Eindhoven is the lead sponsor of 80 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Microvascular angina (MVA):
Vasospastic angina (VSA):
Persisting angina pectoris despite optimal medical therapy (OMT) defined as:
Exclusion Criteria:
See intervention: all patients included in the study will receive TENS treatment for a period of 1 month
Device: Transcutaneous Electrical Nerve Stimulation
Device consists of two electrodes that are applied to the chest region and are connected to a battery operated TENS (Frequency 80Hz, pulse width 150us and amplitude variable (patient dependent)). The device will be used a minimum of three times daily for 30 minutes and additionally during symptoms.
Also known as: TENS
Change in summary score of Seattle Angina Questionnaire
Change in the summary score of the Seattle Angina Questionnaire (SS SAQ) after 1 month treatment with TENS, compared to baseline.
Time frame: Baseline; 1 month
Change in physical limitations domain of Seattle Angina Questionnaire
Change in physical limitations domain of the Seattle Angina Questionnaire (PL SAQ) after 1 month treatment with TENS, compared to baseline.
Time frame: Baseline; 1 month
Change in angina frequency domain of Seattle Angina Questionnaire
Change in angina frequency domain of the Seattle Angina Questionnaire (AF SAQ) after 1 month treatment with TENS, compared to baseline.
Time frame: Baseline; 1 month
Change in angina stability domain of Seattle Angina Questionnaire
Change in angina stability domain of the Seattle Angina Questionnaire (AS SAQ) after 1 month treatment with TENS, compared to baseline.
Time frame: Baseline; 1 month
Change in treatment satisfaction domain of Seattle Angina Questionnaire
Change in treatment satisfaction domain of the Seattle Angina Questionnaire (TS SAQ) after 1 month treatment with TENS, compared to baseline.
Time frame: Baseline; 1 month
Change in quality of life domain of Seattle Angina Questionnaire
Change in quality of life domain of the Seattle Angina Questionnaire (QoL SAQ) after 1 month treatment with TENS, compared to baseline.
Time frame: Baseline; 1 month
Changes in patient condition
Change in patient condition using the 6-minute walking test after 1 month treatment with TENS, compared to baseline
Time frame: Baseline; 1 month
Change in CCS class
Change in grading of angina pectoris using the Canadian Cardiovascular Society (CCS) class after 1 month treatment with TENS compared to baseline
Time frame: Baseline; 1 month
Side effects of TENS use
Register all side effects (such as skin irritation, tenderness and/or TENS discomfort) experienced by the patient over the 1 month treatment period
Time frame: 1 month
Plan to share: No
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Catharina Ziekenhuis Eindhoven