Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06401291
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-05-02
Brief Title:
Transcutaneous Electrical Nerve Stimulation in Patients With Angina and Non-Obstructive Coronary Arteries
Sponsor:
Catharina Ziekenhuis Eindhoven
Organization:
Catharina Ziekenhuis Eindhoven
Study Overview
Official Title:
The Novel Use of Transcutaneous Electrical Nerve Stimulation in Patients With Angina and Non-Obstructive Coronary Arteries a Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TENS-ANOCA
Brief Summary:
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 andor trimetazidine In VSA calcium channel blocker long-acting nitrate andor 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 andor 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
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 andor trimetazidine In VSA calcium channel blocker long-acting nitrate andor 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 andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None