Health TrialsbyHealthPanel

ACCELERATE-CMR for Coronary Artery Disease Detection

ConditionCAD - Coronary Artery Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Leicester

About this trial

Coronary heart disease occurs when the blood vessels that supply the heart become narrowed or blocked. It is a leading cause of illness and death in the UK. Accurate diagnosis is important because effective treatments are available, but current tests are invasive, uncomfortable, and carry some risks.

Cardiovascular magnetic resonance (CMR), also known as a heart MRI scan, is a safe and accurate test for diagnosing coronary heart disease. However, access to CMR is limited because standard scans take around 45 to 50 minutes, restricting the number of patients who can be scanned.

Researchers have developed a faster CMR scan that takes only 15 to 20 minutes. Previous studies suggest that this shorter scan provides similar accuracy to the standard scan while improving patient comfort.

This study will recruit 2022 adults with suspected coronary heart disease from hospitals in the UK. Participants will be randomly assigned to receive either the standard CMR scan or the faster CMR scan.

The study will compare whether the accelerated scan provides similar clinical outcomes to the standard scan and whether patients prefer it. If successful, the accelerated scan could increase access to CMR by allowing more patients to be scanned each day, and enabling more efficient use of NHS resources.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

A) with chest pain or angina equivalent OR

Willing and able to consent to participate in the trial

Disqualifiers

absolute contraindications to CMR (non-conditional cardiac implantable electronic devices, metallic implants/foreign bodies),

contraindications to adenosine (severe pulmonary disease, sinus-node/high-grade atrioventricular disease)

severe kidney dysfunction (estimated glomerular filtration rate [eGFR] <30ml/min/1.73m2)

uncontrolled arrhythmia or unstable chest pain

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard stress cardiovascular magnetic resonance (CMR)

    Procedure/Surgery

    Standard stress cardiovascular magnetic resonance (CMR) scan performed according to the study protocol.

  • Accelerated stress cardiovascular magnetic resonance (CMR)

    Procedure/Surgery

    Accelerated stress cardiovascular magnetic resonance (CMR) scan performed according to the study protocol.

Treatment groups

2,022 Participants
are divided into 2 treatment groups
Group A: Standard care arm stress CMRActive comparator 1 intervention
Group B: Accelerated stress CMRExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Composite clinical endpoint

Composite of unnecessary invasive coronary angiography, unplanned coronary revascularisation, and additional non-invasive cardiac testing.

Time frame
12 months

Secondary outcomes

1

Patient acceptability assessed using the MRI Scan Acceptability Theoretical Framework of Acceptability (TFA) Questionnaire

Patient acceptability of the diagnostic pathway assessed immediately following the MRI scan using the MRI Scan Acceptability Theoretical Framework of Acceptability (TFA) Questionnaire.

Time frame
Baseline (immediately following the MRI scan)
2

Patient anxiety assessed using the MRI Scan Anxiety Questionnaire (MRI-AQ)

Patient anxiety during the diagnostic pathway assessed immediately following the MRI scan using the MRI Scan Anxiety Questionnaire (MRI-AQ).

Time frame
Baseline (immediately following the MRI scan)
3

Unnecessary invasive coronary angiography

Incidence of unnecessary invasive coronary angiography.

Time frame
12 months, 24 months
4

Unplanned coronary revascularisation

Incidence of unplanned coronary revascularisation.

Time frame
12 months, 24 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Leicester

Lead sponsor

University of Glasgow

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: