Non-invasive Diagnosis of Coronary Microvascular Disease: Pilot Study

NCT06070662 | Recruiting

• 1 other identifier: 0844
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Microvascular Angina

Keywords

Coronary microvascular disease; Angina; Non-invasive testing

Outcome Measures

Primary Outcomes (5)

• The ability of coronary luminal volume to myocardial mass (V/M) ratio measured using CT to identify the presence of CMD demonstrated by invasive coronary physiological assessment in patients with angina.

  At time of imaging scan

• The ability of T1 mapping at rest and exercise to identify the presence of CMD demonstrated by invasive coronary physiological assessment in patients with angina.

  At time of imaging scan

• The ability of Blood oxygen level-dependent CMR (BOLD-CMR) at rest and exercise at rest and exercise to identify the presence of CMD demonstrated by invasive coronary physiological assessment in patients with angina.

  At time of imaging scan

• The ability of CMR perfusion imaging at rest and exercise to identify the presence of CMD demonstrated by invasive coronary physiological assessment in patients with angina.

  At time of imaging scan

• The ability of myocardial blood volume as measured by CMR first-pass perfusion imaging at rest and during exercise to identify the presence of CMD demonstrated by invasive coronary physiological assessment in patients with angina.

  At time of imaging scan

Secondary Outcomes (2)

• T1 mapping at rest and adenosine-induced hyperaemia to identify the presence of CMD demonstrated by invasive coronary physiological assessment in patients with angina.

  At time of imaging scan

• CMR perfusion imaging at rest and adenosine-induced hyperaemia to identify the presence of CMD demonstrated by invasive coronary physiological assessment in patients with angina.

  At time of imaging scan

Study Arms (3)

Suspected coronary microvascular disease confirmed at angiography (expected n=8)

Individuals with suspected coronary microvascular disease based on CT and MRI scans completed as part of the main research study. Those with confirmed coronary microvascular disease will complete an MRI scan as part of this pilot study and their CT scan will undergo additional analysis.

Diagnostic Test: Coronary microvascular disease testing during coronary angiography; Diagnostic Test: Cardiac magnetic resonance scan including exercise; Diagnostic Test: Additional analysis of already acquired CT scan

Suspected coronary microvascular disease not confirmed at angiography (expected n=4)

Individuals with suspected coronary microvascular disease based on CT and MRI scans completed as part of the main research study. If this is not confirmed coronary microvascular disease they will not undergo any further investigations as part of this research study.

Diagnostic Test: Coronary microvascular disease testing during coronary angiography

Multivessel coronary artery disease (n=12)

Individuals with multivessel coronary artery disease, diagnosed based on CT and MRI scans completed as part of the main research study and confirmed at angiography.

Diagnostic Test: Coronary microvascular disease testing during coronary angiography; Diagnostic Test: Cardiac magnetic resonance scan including exercise; Diagnostic Test: Additional analysis of already acquired CT scan

Interventions

Coronary microvascular disease testing during coronary angiography DIAGNOSTIC_TEST

During invasive coronary angiography, in addition to coronary angiography performed as per routine clinical care, participants will have angiographic testing for coronary microvascular disease using routine clinical procedures. This will consist of fractional flow reserve (FFR), coronary flow reserve, index of microvascular resistance and vasospasm provocation testing with acetylcholine (Ach).

Multivessel coronary artery disease (n=12); Suspected coronary microvascular disease confirmed at angiography (expected n=8); Suspected coronary microvascular disease not confirmed at angiography (expected n=4)

Cardiac magnetic resonance scan including exercise DIAGNOSTIC_TEST

Participants will undergo a cardiac magnetic resonance scan compromising 1) T1 mapping, 2) oxygenation-sensitive MRI and 3) perfusion imaging. All will be obtained at rest and during exercise using a step ergometer.

Multivessel coronary artery disease (n=12); Suspected coronary microvascular disease confirmed at angiography (expected n=8)

Additional analysis of already acquired CT scan DIAGNOSTIC_TEST

Previously acquired CTCA images from the main research study will be transferred to Heartflow for computation of coronary blood volume.

Multivessel coronary artery disease (n=12); Suspected coronary microvascular disease confirmed at angiography (expected n=8)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with suspected angina referred for invasive coronary angiography who are a current participants of the 'CMR versus CT-FFR in CAD' study.

You may qualify if:

• Current participant of the 'CMR versus CT-FFR in CAD' 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leicester: lead

Study Sites (1)

Glenfield Hospital, University Hospitals of Leicester

Leicester, Leicestershire, United Kingdom

RECRUITING

MeSH Terms

Conditions

Microvascular Angina; Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ranjit Arnold

  University of Leicester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ranjit Arnold

CONTACT

+44116 258 3038; jra14@leicester.ac.uk

Sarah L Ayton, MBBS

CONTACT

sa768@leicester.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: October 6, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

GB (1)