Non-invasive Diagnosis of Coronary Microvascular Disease: Pilot Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Leicester

About this trial

* 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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 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).

  • 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.

  • 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.

Treatment groups

20 Participants
are divided into 3 treatment groups
Group A: Suspected coronary microvascular disease confirmed at angiography (expected n=8)3 interventions
Group B: Suspected coronary microvascular disease not confirmed at angiography (expected n=4)1 intervention
Group C: Multivessel coronary artery disease (n=12)3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
At time of imaging scan
2

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.

Time frame
At time of imaging scan
3

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.

Time frame
At time of imaging scan
4

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.

Time frame
At time of imaging scan

Secondary outcomes

1

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

Time frame
At time of imaging scan
2

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.

Time frame
At time of imaging scan

Other outcomes

Sponsors and contacts

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