Coronary Microvascular Dysfunction (CMD)REDEFINE-CMDNCT07337005
CompREhensive Diagnostic Assessment of Coronary Endothelial Function Impairment and Vasospasm With CoNtinuous ThErmodilution in Patients With Suspected Coronary Microvascular and Vasomotor Dysfunction
A study testing Invasive coronary physiological measurements in people with Coronary Microvascular Dysfunction (CMD) and Vasospasm, Coronary, run by Mid and South Essex NHS Foundation Trust.
Trial summary
The goal of this observational study is to learn more about the diagnosis of coronary endothelium function and coronary vasospasm using a dedicated invasive protocol in patients who has angina without obstruction in their main heart arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Microvascular Dysfunction (CMD), Vasospasm, Coronary
- What is being tested?
- Invasive coronary physiological measurements
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2025to Dec 2027
- 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
- Patients with symptoms suggestive of angina.
- Evidence of unobstructed coronary arteries on invasive or non-invasive coronary angiography (coronary stenosis <50% and /or FFR >0.80).
- Above the age of 18.
- The subject has been informed of the nature of the study, agrees to its provisions and has signed written informed consent.
Who cannot join
- Pregnancy.
- Contraindication to angiography and/or physiological assessment with adenosine or acetylcholine.
- Previous coronary artery bypass graft (CABG).
- Moderate to severe valvular heart disease.
About this study
The goal of this observational study is to learn more about the diagnosis of coronary endothelium function and coronary vasospasm using a dedicated invasive protocol in patients who has angina without obstruction in their main heart arteries. The main question it aims to answer is the feasibility, reproducibility, and safety of this invasive protocol:
Does this invasive protocol diagnose coronary endothelial dysfunction and vasospasm without issues?
Read more
Participants already having invasive coronary angiogram and physiological studies will undergo additional physiological measurements during the same procedure.
Participants will enrol in a symptoms and quality of life questionnaire using dedicated questionnaires and a mobile application to assess the burden of their symptoms before and after the invasive procedure and up to 12 months follow up.
A subset of participants will undergo a repeat set of these measurements to assess reproducibility of the invasive protocol.
A subset of the participants will also undergo a cardiac MRI to assess correlation with the invasive protocol measurements.
- Being tested
- Invasive coronary physiological measurements
- Medical subject headings
- Coronary Vasospasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive coronary physiological measurementsProcedure or surgery
Invasive assessment of changes in coronary blood flow, resistance, and distal pressure in response to acetylcholine infusion. These will be measured during a clinical indicated invasive coronary angiogram procedure and physiological studies using a standard coronary pressure wire and a dedicated infusion catheter.
| Study group | Role | What they receive |
|---|---|---|
| Invasive Coronary function Assessment arm | Experimental | Invasive coronary endothelial function and vasospasm assessment Receives: Procedure: Invasive coronary physiological measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility outcome
Proportion of patients in whom the full invasive protocol (baseline and post-stimulation measurements) is successfully completed without major technical issues or protocol deviations.
Measured: At baseline
Secondary outcomes (5)
Reproducibility outcome
Intra- and inter-operator variability of measurements quantified using intraclass correlation coefficients and Bland-Altman plots in a predefined reproducibility subset.
Measured: At baseline
Safety outcome
Incidence of adverse events related to the procedure or medications.
Measured: At Baseline and up to 12 months
Correlation between invasive and non-invasive measures of endothelial-dependent coronary microvascular dysfunction.
Strength of correlation (unit of measure = correlation coefficient, r) between invasive indices of endothelial-dependent coronary microvascular function obtained during the study protocol (absolute coronary blood flow and absolute microvascular resistance measured by continuous thermodilution during intracoronary acetylcholine testing) and non-invasive measures of myocardial perfusion (myocardial perfusion reserve obtained from cardiac stress perfusion imaging). Diagnostic agreement for identifying endothelial-dependent microvascular dysfunction will also be assessed (unit of measure = area under ROC curve, sensitivity, and specificity), using the invasive assessment as the reference standard.
Measured: From baseline and up to 3 months
Correlation between invasive physiological indices of coronary microvascular function and symptom burden at baseline.
The strength of correlation (Pearson or Spearman correlation coefficient; unit of measure = correlation coefficient, r) between invasive physiological measurements of coronary microvascular function obtained during the study protocol (e.g., absolute coronary blood flow and absolute microvascular resistance derived by continuous thermodilution during acetylcholine testing) and patient-reported symptom burden assessed at baseline using validated questionnaires (Seattle Angina Questionnaire-7 [SAQ-7] and EQ-5D-5L scores).
Measured: Baseline (at time of invasive coronary function testing).
Change in symptoms, quality of life, and need for further investigation or treatment during follow-up.
Change from baseline to follow-up in patient-reported symptoms and quality of life (unit of measure = change in questionnaire score) as assessed using the SAQ-7 and EQ-5D-5L questionnaires, and the proportion of patients (%) requiring additional cardiac investigations or treatment changes during follow-up.
Measured: From baseline to 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start15 Dec 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mid and South Essex NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337005
- Sponsor's protocol ID
- IRAS 356198
- Acronym
- REDEFINE-CMD
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- 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 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CompREhensive Diagnostic Assessment of Coronary Endothelial Function Impairment and Vasospasm With CoNtinuous ThErmodilution in Patients With Suspected Coronary Microvascular and Vasomotor Dysfunction
- ClinicalTrials.gov ID
- NCT07337005
- Acronym / sponsor ID
- REDEFINE-CMD / IRAS 356198
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mid and South Essex NHS Foundation TrustUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Jan 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.
The goal of this observational study is to learn more about the diagnosis of coronary endothelium function and coronary vasospasm using a dedicated invasive protocol in patients who has angina without obstruction in their main heart arteries. The main question it aims to answer is the feasibility, reproducibility, and safety of this invasive protocol:
Does this invasive protocol diagnose coronary endothelial dysfunction and vasospasm without issues?
Participants already having invasive coronary angiogram and physiological studies will undergo additional physiological measurements during the same procedure.
Participants will enrol in a symptoms and quality of life questionnaire using dedicated questionnaires and a mobile application to assess the burden of their symptoms before and after the invasive procedure and up to 12 months follow up.
A subset of participants will undergo a repeat set of these measurements to assess reproducibility of the invasive protocol.
A subset of the participants will also undergo a cardiac MRI to assess correlation with the invasive protocol measurements.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Invasive Coronary function Assessment arm | Experimental | Procedure: Invasive coronary physiological measurementsInvasive coronary endothelial function and vasospasm assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with symptoms suggestive of angina.
- Evidence of unobstructed coronary arteries on invasive or non-invasive coronary angiography (coronary stenosis <50% and /or FFR >0.80).
- Above the age of 18.
- The subject has been informed of the nature of the study, agrees to its provisions and has signed written informed consent.
Key exclusion criteria (4 listed)
- Pregnancy.
- Contraindication to angiography and/or physiological assessment with adenosine or acetylcholine.
- Previous coronary artery bypass graft (CABG).
- Moderate to severe valvular heart disease.
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 |
|---|---|---|
| Invasive coronary physiological measurementsInvasive assessment of changes in coronary blood flow, resistance, and distal pressure in response to acetylcholine infusion. These will be measured during a clinical indicated invasive coronary angiogram procedure and physiological studies using a standard coronary pressure wire and a dedicated infusion catheter. | Procedure or surgery | Invasive Coronary function Assessment arm |
Primary outcome
Feasibility outcome
Time frame: At baseline
Proportion of patients in whom the full invasive protocol (baseline and post-stimulation measurements) is successfully completed without major technical issues or protocol deviations.
5 secondary outcomes
Reproducibility outcome
Time frame: At baseline
Safety outcome
Time frame: At Baseline and up to 12 months
Correlation between invasive and non-invasive measures of endothelial-dependent coronary microvascular dysfunction.
Time frame: From baseline and up to 3 months
Correlation between invasive physiological indices of coronary microvascular function and symptom burden at baseline.
Time frame: Baseline (at time of invasive coronary function testing).
Change in symptoms, quality of life, and need for further investigation or treatment during follow-up.
Time frame: From baseline to 12 months follow-up
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 13 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Coronary Microvascular Dysfunction (CMD)
Recruiting
Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women
ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD)
Recruiting
Mental Stress Reactivity in Women With CMD
Post-menopause
Active, not recruiting
Insulin Resistance and Coronary Microvascular Dysfunction in Patients With Myocardial Ischemia and Non-obstructive Coronary Artery Disease
Coronary Microvascular Dysfunction, Coronary Microvascular Disease
Not yet recruiting
A Plant-Based Diet in the Treatment of Coronary Microvascular Dysfunction
Coronary Microvascular Dysfunction
RecruitingPhase 1
Study Targeting Myocardial Perfusion and Symptom Relief in Women With SGLT2 Inhibitors (STRONG)
Angina Patients With Non-obstructive Coronary Artery Disease, Coronary Microvascular Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Invasive coronary physiological measurements in people with Coronary Microvascular Dysfunction (CMD) and Vasospasm, Coronary, run by Mid and South Essex NHS Foundation Trust.
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 4 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: opening soon, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Feasibility outcome (time frame: At baseline). 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 13 Jan 2026.