Microvascular AnginaTENS-ANOCANCT06401291
Transcutaneous Electrical Nerve Stimulation in Patients With Angina and Non-Obstructive Coronary Arteries
A study testing Transcutaneous Electrical Nerve Stimulation in people with Microvascular Angina and Vasospastic Angina, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microvascular Angina, Vasospastic Angina
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Mar 2024to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
Show all 14Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Catharina Hospital
Eindhoven, North Brabant, 5623EJ
Fabienne E Vervaat, MD, 0031402397000, fabienne.vervaat@catharinaziekenhuis.nl
About this study
Official title: The Novel Use of Transcutaneous Electrical Nerve Stimulation in Patients With Angina and Non-Obstructive Coronary Arteries: a Pilot Study
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.
Read more
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
- Being tested
- Transcutaneous Electrical Nerve Stimulation
- Medical subject headings
- Microvascular Angina, Angina Pectoris, Variant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve StimulationDevice
Also called TENS
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.
| Study group | Role | What they receive |
|---|---|---|
| Open label | Other | See intervention: all patients included in the study will receive TENS treatment for a period of 1 month Receives: Device: Transcutaneous Electrical Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline; 1 month
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Baseline; 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start13 Mar 2024
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microvascular AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients who meet the inclusion criteria will receive TENS treatment for a period of 1 month. At baseline and at 1 month evaluation will take place.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inge Wijnbergen, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401291
- Sponsor's protocol ID
- NL84910.100.23
- Acronym
- TENS-ANOCA
- Status last verified
- May 2024
- First submitted
- 2 May 2024
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Novel Use of Transcutaneous Electrical Nerve Stimulation in Patients With Angina and Non-Obstructive Coronary Arteries: a Pilot Study
- ClinicalTrials.gov ID
- NCT06401291
- Acronym / sponsor ID
- TENS-ANOCA / NL84910.100.23
- Conditions
- Microvascular Angina, Vasospastic Angina
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients who meet the inclusion criteria will receive TENS treatment for a period of 1 month. At baseline and at 1 month evaluation will take place.
| Arm | Type | Receives |
|---|---|---|
| Open label | Other | Device: Transcutaneous Electrical Nerve StimulationSee intervention: all patients included in the study will receive TENS treatment for a period of 1 month |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Angina and no obstructive coronary artery disease (ANOCA) (CCS class III or IV)
- Microvascular angina (MVA):
- Vasospastic angina (VSA):
- Persisting angina pectoris despite optimal medical therapy (OMT) defined as:
- Age > 18 years
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Electrical Nerve StimulationAlso: TENSDevice 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. | Device | Open label |
Primary outcome
Change in summary score of Seattle Angina Questionnaire
Time frame: Baseline; 1 month
Change in the summary score of the Seattle Angina Questionnaire (SS SAQ) after 1 month treatment with TENS, compared to baseline.
7 secondary outcomes
Change in physical limitations domain of Seattle Angina Questionnaire
Time frame: Baseline; 1 month
Change in angina frequency domain of Seattle Angina Questionnaire
Time frame: Baseline; 1 month
Change in angina stability domain of Seattle Angina Questionnaire
Time frame: Baseline; 1 month
Change in treatment satisfaction domain of Seattle Angina Questionnaire
Time frame: Baseline; 1 month
Change in quality of life domain of Seattle Angina Questionnaire
Time frame: Baseline; 1 month
Changes in patient condition
Time frame: Baseline; 1 month
Change in CCS class
Time frame: Baseline; 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation in people with Microvascular Angina and Vasospastic Angina, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Inge Wijnbergen, MD, PhD (+31402397000, inge.wijnbergen@catharinaziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in summary score of Seattle Angina Questionnaire (time frame: Baseline; 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.