NCT06070662 Non-invasive Diagnosis of Coronary Microvascular Disease: Pilot Study
| NCT ID | NCT06070662 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Leicester |
| Condition | Microvascular Angina |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-11-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2023-11-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
* 40% of patients presenting with stable chest pain (angina) have no significant blockage of the main heart arteries. Identifying why these patients have symptoms will mean better treatment options can be developed. * About 60% of these patients have evidence of coronary microvascular disease (CMD). In this condition there is a problem with the heart's microvessels (very small blood vessels that branch from the main heart arteries). Due to problems with these vessels there is a mismatch between the blood supply to the heart and its oxygen consumption, causing chest pain and this can also lead to major heart events. * At present, to diagnose this condition, specialised techniques during an invasive test, called a coronary angiogram, are required. As this is an invasive test, it can be lead to complications and cause discomfort. * Non-invasive ways of diagnosing CMD are required to improve the diagnosis and management of this condition. * This study aims to provide initial data on whether novel imaging techniques using CT and MRI scans, which are much less invasive, could identify CMD. * To do this, patients with suspected angina referred for angiography and who are already participants in the main research study 'CMR versus CT-FFR in CAD' study will be recruited. * These will be patients with suspected CMD and also those with blockage of the main heart arteries (triple vessel disease) to compare against. * Participants in this pilot study will have additional tests used to diagnose CMD during their invasive angiography procedure. Participants will then have an MRI scan involving novel techniques and exercise MRI, where individuals exercise use a cycle or stepping machine during the MRI scan. Further analysis will also be undertaken of CT images acquired as part of the main study. * These tests will be compared against invasive test results to see which show potential in being able to diagnose CMD.
Eligibility Criteria
Inclusion Criteria: * Current participant of the 'CMR versus CT-FFR in CAD' study * Continue to meet the inclusion criteria for the main study: * Patients aged ≥18 years * Referred for invasive coronary angiography for investigation of chest pain * Willing and able to give informed consent * Willing and able (in the Investigators opinion) to comply with all study requirements. * Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study. * Able to understand written English * Able to perform exercise in the MRI scanner Study arm: * No evidence of obstructive or non-obstructive CAD on research CTCA * Myocardial perfusion defect detected on adenosine stress CMR indicative of CMD Control arm: • Evidence of multivessel CAD on research CTCA Exclusion Criteria: * Meet the exclusion criteria for the main study: * Recent acute coronary syndrome (\< 6 months) * Severe claustrophobia * Absolute contraindications to CMR - those with MR conditional or safe devices will be included * Second-/third-degree atrioventricular block * Severe chronic obstructive pulmonary disease * Moderate-severe asthma * Estimated glomerular filtration rate \<30 ml/min/1.73m2 * Women who are pregnant, breast-feeding or of child-bearing potential (premenopausal women) * Contraindication to iodinated contrast * Participants who have participated in a research study involving an investigational product in the past 12 weeks * Patients unable to understand written English
Contact & Investigator
Ranjit Arnold
PRINCIPAL INVESTIGATOR
University of Leicester
Frequently Asked Questions
Who can join the NCT06070662 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Microvascular Angina. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06070662 currently recruiting?
Yes, NCT06070662 is actively recruiting participants. Contact the research team at jra14@leicester.ac.uk for enrollment information.
Where is the NCT06070662 trial being conducted?
This trial is being conducted at Leicester, United Kingdom.
Who is sponsoring the NCT06070662 clinical trial?
NCT06070662 is sponsored by University of Leicester. The principal investigator is Ranjit Arnold at University of Leicester. The trial plans to enroll 20 participants.