Coronary Microvascular Dysfunction (CMD)ERICOMNCT07670091
Endothelin Role In COronary Microcirculation
A study testing Cardiac MRI, Invasive Coronary Angiogram and Endothelin Receptor Antagonist in people with Coronary Microvascular Dysfunction (CMD) and Angina Pectoris With Normal Coronary Arteriogram, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Coronary microvascular dysfunction is an important cause of angina in patients who do not have significant blockages in the major coronary arteries. Previous studies suggest that endothelin-1, a naturally occurring substance that causes blood vessel constriction, may contribute to abnormalities in the coronary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Microvascular Dysfunction (CMD), Angina Pectoris With Normal Coronary Arteriogram, Microvascular Angina
- What is being tested?
- Cardiac MRI, Invasive Coronary Angiogram and Endothelin Receptor Antagonist
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2023to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Clinical diagnosis of symptomatic angina, defined as the presence of substernal chest pain or discomfort provoked by exertion or emotional stress and relieved by rest and/or glyceryl trinitrate (nitroglycerin).
- Age 18 years or older.
- Able and willing to provide written informed consent.
- Able and willing to adhere to study procedures and follow-up requirements.
Who cannot join
- Symptoms consistent with unstable angina, including:
- Angina at rest lasting more than 20 minutes.
- New-onset severe angina.
- Angina increasing in frequency, duration, or occurring at a lower threshold.
- Angina occurring following a recent myocardial infarction.
- Known significant coronary artery disease, defined as previous investigations demonstrating greater than 50% epicardial coronary artery stenosis.
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- Uncontrolled hypertension, defined as clinic blood pressure greater than 140/90 mmHg despite treatment with three or more antihypertensive medications.
- Pregnancy or breastfeeding.
- Poorly controlled asthma as defined in the study protocol.
- Severe heart failure or symptoms of active heart failure.
- Significant chronic kidney disease, defined as estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m².
- Clinical evidence of active infection at the time of recruitment.
- Significant liver disease, defined as Child-Pugh Class B or C liver disease (or worse than Child-Pugh Class A).
- Systolic blood pressure less than 90 mmHg at the time of recruitment.
- Previously documented allergy or hypersensitivity to endothelin receptor antagonists.
- Concurrent use of medications contraindicated with endothelin receptor antagonist therapy.
- Requirement for invasive coronary angiography for another clinical indication, including but not limited to valvular heart disease assessment or intervention.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NHS University Hospitals of Liverpool Group
Liverpool
About this study
Official title: Determining the Role of Endothelin in Microcirculatory Function in Myocardial Ischaemia
Coronary microvascular dysfunction is an important cause of angina in patients who do not have significant blockages in the major coronary arteries. Previous studies suggest that endothelin-1, a naturally occurring substance that causes blood vessel constriction, may contribute to abnormalities in the coronary microcirculation.
The ERICOM study aims to investigate whether treatment with bosentan, an endothelin receptor antagonist, can improve coronary microvascular function in patients with angina and evidence of coronary microvascular dysfunction. Participants undergo cardiovascular magnetic resonance (CMR) imaging before and after treatment, and some participants also undergo invasive coronary physiological assessment.
The results of this study may improve understanding of the role of endothelin-1 in coronary microvascular dysfunction and help identify new treatment strategies for patients with angina and non-obstructive coronary artery disease.
Read the detailed description
Coronary microvascular dysfunction (CMD) is increasingly recognised as a major cause of myocardial ischaemia and angina in patients without obstructive epicardial coronary artery disease. CMD is a key mechanism underlying ischaemia with non-obstructive coronary arteries (INOCA) and is associated with impaired quality of life, recurrent healthcare utilisation, and adverse cardiovascular outcomes.
Endothelin-1 (ET-1) is a potent endogenous vasoconstrictor peptide that has been implicated in endothelial dysfunction, vascular inflammation, and microvascular dysregulation. Elevated circulating ET-1 concentrations have been reported in patients with microvascular angina and may contribute to increased coronary microvascular resistance and impaired myocardial perfusion.
The ERICOM study is a prospective, single-arm mechanistic study designed to investigate the relationship between ET-1 and coronary microvascular dysfunction and to assess the effects of endothelin receptor antagonism on coronary microvascular function.
Participants with angina symptoms and evidence of coronary microvascular dysfunction undergo baseline clinical assessment, blood sampling for ET-1 measurement, and stress cardiovascular magnetic resonance (CMR) imaging. Participants receive bosentan therapy for four weeks followed by repeat stress CMR imaging. A subset of participants undergoes invasive coronary angiography with physiological assessment, including measurements of coronary flow reserve (CFR), index of microcirculatory resistance (IMR), fractional flow reserve (FFR), and resting full-cycle ratio (RFR).
The primary objective is to determine whether bosentan therapy improves coronary microvascular function as assessed by serial CMR-derived myocardial perfusion measurements. Secondary objectives include evaluating associations between ET-1 concentrations and CMD, assessing relationships between invasive and non-invasive measures of coronary microvascular function, and exploring mechanistic pathways linking endothelin signalling and coronary microvascular disease.
The study is sponsored by Liverpool University Hospitals NHS Foundation Trust and conducted in accordance with Good Clinical Practice, Research Ethics Committee approval, and Health Research Authority approval.
- Conditions
- Coronary Microvascular Dysfunction (CMD), Angina Pectoris With Normal Coronary Arteriogram, Microvascular Angina
- Being tested
- Cardiac MRI, Invasive Coronary Angiogram, Endothelin Receptor Antagonist
- Keywords
- ERICOM, Microvascular Angina, Ischemia With Non-Obstructive Coronary Arteries (INOCA), Coronary Microvascular Dysfunction
- Medical subject headings
- Microvascular Angina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRIDiagnostic test
Cardiac stress/perfusion MRI scan
Invasive Coronary AngiogramProcedure or surgery
Invasive Coronary Angiogram with pressure wire assessments
Endothelin Receptor AntagonistDrug
Participants will be given PO Bosentan 125 mg BD for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | 45 participants will undergo Cardiac MRI and invasive catheterization, and then given PO Endothelin Receptors Antagonists for 4 weeks. Participants will then have a repeat cardiac MRI. Receives: Diagnostic Test: Cardiac MRI; Procedure: Invasive Coronary Angiogram; Drug: Endothelin Receptor Antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Myocardial Perfusion Reserve Index (MPRI) following Bosentan treatment
Within-participant change in myocardial perfusion reserve index (MPRI) measured by stress cardiovascular magnetic resonance imaging before and after four weeks of Bosentan therapy.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start1 Jul 2023
- Primary completion31 Jul 2025
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Microvascular Dysfunction (CMD)Studies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Michael Fisher, Principal investigator, NHS University Hospitals of Liverpool Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670091
- Sponsor's protocol ID
- SP0323
- Acronym
- ERICOM
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Role of Endothelin in Microcirculatory Function in Myocardial Ischaemia
- ClinicalTrials.gov ID
- NCT07670091
- Acronym / sponsor ID
- ERICOM / SP0323
- Conditions
- Coronary Microvascular Dysfunction (CMD), Angina Pectoris With Normal Coronary Arteriogram, Microvascular Angina
- Keywords
- ERICOM, Microvascular Angina, Ischemia With Non-Obstructive Coronary Arteries (INOCA), Coronary Microvascular Dysfunction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Liverpool University Hospitals NHS Foundation TrustOther government
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 26 Jun 2026 (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.
Coronary microvascular dysfunction is an important cause of angina in patients who do not have significant blockages in the major coronary arteries. Previous studies suggest that endothelin-1, a naturally occurring substance that causes blood vessel constriction, may contribute to abnormalities in the coronary microcirculation.
The ERICOM study aims to investigate whether treatment with bosentan, an endothelin receptor antagonist, can improve coronary microvascular function in patients with angina and evidence of coronary microvascular dysfunction. Participants undergo cardiovascular magnetic resonance (CMR) imaging before and after treatment, and some participants also undergo invasive coronary physiological assessment.
The results of this study may improve understanding of the role of endothelin-1 in coronary microvascular dysfunction and help identify new treatment strategies for patients with angina and non-obstructive coronary artery disease.
Detailed description
Coronary microvascular dysfunction (CMD) is increasingly recognised as a major cause of myocardial ischaemia and angina in patients without obstructive epicardial coronary artery disease. CMD is a key mechanism underlying ischaemia with non-obstructive coronary arteries (INOCA) and is associated with impaired quality of life, recurrent healthcare utilisation, and adverse cardiovascular outcomes.
Endothelin-1 (ET-1) is a potent endogenous vasoconstrictor peptide that has been implicated in endothelial dysfunction, vascular inflammation, and microvascular dysregulation. Elevated circulating ET-1 concentrations have been reported in patients with microvascular angina and may contribute to increased coronary microvascular resistance and impaired myocardial perfusion.
The ERICOM study is a prospective, single-arm mechanistic study designed to investigate the relationship between ET-1 and coronary microvascular dysfunction and to assess the effects of endothelin receptor antagonism on coronary microvascular function.
Participants with angina symptoms and evidence of coronary microvascular dysfunction undergo baseline clinical assessment, blood sampling for ET-1 measurement, and stress cardiovascular magnetic resonance (CMR) imaging. Participants receive bosentan therapy for four weeks followed by repeat stress CMR imaging. A subset of participants undergoes invasive coronary angiography with physiological assessment, including measurements of coronary flow reserve (CFR), index of microcirculatory resistance (IMR), fractional flow reserve (FFR), and resting full-cycle ratio (RFR).
The primary objective is to determine whether bosentan therapy improves coronary microvascular function as assessed by serial CMR-derived myocardial perfusion measurements. Secondary objectives include evaluating associations between ET-1 concentrations and CMD, assessing relationships between invasive and non-invasive measures of coronary microvascular function, and exploring mechanistic pathways linking endothelin signalling and coronary microvascular disease.
The study is sponsored by Liverpool University Hospitals NHS Foundation Trust and conducted in accordance with Good Clinical Practice, Research Ethics Committee approval, and Health Research Authority approval.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Diagnostic Test: Cardiac MRI, Procedure: Invasive Coronary Angiogram, Drug: Endothelin Receptor Antagonist45 participants will undergo Cardiac MRI and invasive catheterization, and then given PO Endothelin Receptors Antagonists for 4 weeks. Participants will then have a repeat cardiac MRI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of symptomatic angina, defined as the presence of substernal chest pain or discomfort provoked by exertion or emotional stress and relieved by rest and/or glyceryl trinitrate (nitroglycerin).
- Age 18 years or older.
- Able and willing to provide written informed consent.
- Able and willing to adhere to study procedures and follow-up requirements.
Key exclusion criteria (17 listed)
- Symptoms consistent with unstable angina, including:
- Angina at rest lasting more than 20 minutes.
- New-onset severe angina.
- Angina increasing in frequency, duration, or occurring at a lower threshold.
- Angina occurring following a recent myocardial infarction.
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 |
|---|---|---|
| Cardiac MRICardiac stress/perfusion MRI scan | Diagnostic test | Interventional group |
| Invasive Coronary AngiogramInvasive Coronary Angiogram with pressure wire assessments | Procedure or surgery | Interventional group |
| Endothelin Receptor AntagonistParticipants will be given PO Bosentan 125 mg BD for 4 weeks. | Drug | Interventional group |
Primary outcome
Change in Myocardial Perfusion Reserve Index (MPRI) following Bosentan treatment
Time frame: Baseline and 4 weeks
Within-participant change in myocardial perfusion reserve index (MPRI) measured by stress cardiovascular magnetic resonance imaging before and after four weeks of Bosentan therapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Study Targeting Myocardial Perfusion and Symptom Relief in Women With SGLT2 Inhibitors (STRONG)
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Self-Expanding Coronary Sinus Reducer for Treatment of Symptomatic Coronary Microvascular Dysfunction (CMD) (SERRA-I Study)
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Women's Ischemia Syndrome Evaluation (WISE) Pre-HFpEF
Coronary Microvascular Dysfunction, Heart Failure With Preserved Ejection Fraction (HFpEF)
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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.
Michael Fisher principal investigator
NHS University Hospitals of Liverpool Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac MRI, Invasive Coronary Angiogram and Endothelin Receptor Antagonist in people with Coronary Microvascular Dysfunction (CMD) and Angina Pectoris With Normal Coronary Arteriogram, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 4 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2026. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Myocardial Perfusion Reserve Index (MPRI) following Bosentan treatment (time frame: Baseline and 4 weeks). 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 26 Jun 2026.