Transcutaneous Electrical Nerve Stimulation in Patients With Angina and Non-Obstructive Coronary Arteries

NCT ID: NCT06401291

Last Updated: 2024-05-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-13
• Study Completion Date: 2024-10-01

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 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).

Conditions

Microvascular Angina; Vasospastic Angina

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open label

See intervention: all patients included in the study will receive TENS treatment for a period of 1 month

Group Type: OTHER

Transcutaneous Electrical Nerve Stimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

TENS

Eligibility Criteria

Inclusion Criteria

• Angina and no obstructive coronary artery disease (ANOCA) (CCS class III or IV)
• Microvascular angina (MVA):

• FFR > 0.8
• CFR < 2.0
• IMR ≥ 25
• Vasospastic angina (VSA):

• FFR > 0.8
• CFR ≥ 2.0
• IMR < 25
• During acetylcholine testing: ≥ 90% diameter reduction, angina pectoris and ischaemic ECG changes
• Persisting angina pectoris despite optimal medical therapy (OMT) defined as:

• MVA: Betablocker, calcium channel blocker, nicorandil and/or ivabradine (Important side note: ranolazine and trimetazidine cannot be prescribed in the Netherlands).
• 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); pacemaker and/or 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role: lead

Responsible Party

Inge Wijnbergen

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Catharina Hospital

Eindhoven, North Brabant, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Inge Wijnbergen, MD, PhD

Role: CONTACT

inge.wijnbergen@catharinaziekenhuis.nl

+31402397000

Fabienne Vervaat, MD

Role: CONTACT

fabienne.vervaat@catharinaziekenhuis.nl

+31402397000

Facility Contacts

Fabienne E Vervaat, MD

Role: primary

fabienne.vervaat@catharinaziekenhuis.nl

0031402397000

Other Identifiers

NL84910.100.23

Identifier Type: -

Identifier Source: org_study_id