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Myocardial Infarction (MI)APRICOTNCT07112820

Contribution of Myocardial Perfusion Imaging in the Initial Assessment of Acute Coronary Syndromes Without ST Elevation for the Diagnosis of Myocardial Infarction or Differential Diagnoses

A study testing perfusion ultrasound in people with Myocardial Infarction (MI), run by Fondation Hôpital Saint-Joseph at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Patients with myocardial infarction require invasive treatment involving coronary angiography to confirm the diagnosis and, in most cases, treatment by angioplasty/stenting. Trans-thoracic ultrasound is central to the initial management of patients admitted to hospital with acute coronary syndrome without ST segment… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myocardial Infarction (MI)
What is being tested?
perfusion ultrasound
How many people
100 participants
Where
1 siteFrance
Study dates
24 Jun 2024to 30 Nov 2026
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

  • Patient over 18 years of age
  • Hospitalised in cardiology as an emergency for acute coronary syndrome without ST segment elevation with indication for coronary angiography within 72 hours of admission
  • Not yet undergone coronary angiography.
  • Troponin >99th percentile, i.e. >27ng/l (troponin I, hypersensitive, Abbott)
  • With de novo segmental kinetic disorder on TTE or ECG repolarisation disorder outside ST elevation
  • Patient affiliated with a health insurance scheme
  • French-speaking patient
  • Patient who has given their free, informed and written consent

Who cannot join

  • Haemodynamically unstable patient: HR > 100 and/or systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 60 mmHg and/or oxygen saturation < 92% in AA and/or clinical signs of hypoperfusion (mottling, cyanosis)
  • Rhythmically unstable patient: sustained ventricular tachycardia, sudden death recovered.
  • Patient with a known allergy to ultrasound contrast medium
  • Patient with ST segment elevation.
  • Patient with a contraindication to MRI.
  • Patient with a caricatured picture of myocarditis (fever and/or significant biological inflammatory syndrome with CRP>50mg/l)
Show all 11Show fewer
  • Patients already included in a type 1 interventional research protocol (RIPH1)
  • Patients under guardianship or curatorship
  • Patients deprived of their liberty
  • Patients under judicial protection
  • Pregnant or breastfeeding patients (negative pregnancy test for women of childbearing age)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yoann MOEUF, medical doctor contact

+33 1 44 12 62 44

ymoeuf@ghpsj.fr

France1 site, 1 recruiting
  • Hospital Paris Saint-Joseph

    Paris, Ilede France, 75014

    Recruiting

Other trials in France

About this study

Patients with myocardial infarction require invasive treatment involving coronary angiography to confirm the diagnosis and, in most cases, treatment by angioplasty/stenting. Trans-thoracic ultrasound is central to the initial management of patients admitted to hospital with acute coronary syndrome without ST segment elevation.

The aim of our study is therefore to compare perfusion ultrasound with coronary angiography and MRI in this population in order to determine whether the performance is satisfactory.

Read the detailed description

Patients with myocardial infarction require invasive treatment via coronary angiography to confirm the diagnosis and, in most cases, treatment by angioplasty/stenting. In the case of acute coronary syndrome without ST segment elevation (NSTEMI), myocardial infarction is suspected but cannot be confirmed. The recommendations suggest that, in cases of low suspicion, a non-invasive ischaemia test should be performed, but in cases of high suspicion, coronary angiography should be performed immediately (1). In cases of NSTEMI, segmental kinetic abnormalities on echocardiography place the patient under high suspicion of infarction and justify coronary angiography without prior ischaemia testing. However, certain kinetic abnormalities may be related to causes other than infarction: stress cardiomyopathy (TakoTsubo), left bundle branch block, pacemaker stimulation, myocarditis, leading to unnecessary and potentially harmful invasive examinations. Transthoracic echocardiography (TTE) is central to the initial management of patients hospitalised for NSTEMI, both to confirm the diagnosis and to detect any immediate complications.The use of contrast agents during TEE is already recommended to improve the quality of the examination, as it increases the echogenicity of patients, and several studies have demonstrated its usefulness in analysing myocardial perfusion (2). The only contrast agent currently available in France is Sonovue® (Bracco Imaging). Microbubbles are lipid 'shells' containing a gas (sulphur), with a diameter similar to that of red blood cells (less than 7 μm). The behaviour of microbubbles in the circulation and capillaries can therefore be likened to that of red blood cells, which allows for better visualisation of all the structures through which blood flows (3). Its use is not contraindicated in the acute phase of a myocardial infarction and has few adverse effects (4).

Several studies have shown that the use of contrast agents during perfusion ultrasound can improve the diagnosis of ischaemic heart disease (5) and distinguish stress-induced heart disease (TakoTsubo) from myocardial infarction (6-8). No studies have looked at patients with kinetic disorders of other aetiologies (bundle branch block, pacemaker).

Furthermore, in certain patients presenting with actual myocardial infarction with segmental kinetic abnormalities but no significant coronary lesions on coronary angiography, myocardial MRI is of definite value in confirming or ruling out the diagnosis of healthy coronary artery infarction (1). However, the use of MRI in routine practice is severely limited by the lack of MRI facilities in many centres or by delays in obtaining results that are incompatible with the urgency of diagnosis.

Compared to computed tomography (CT) and MRI, the advantages of contrast-enhanced ultrasound are 1) the possibility of real-time imaging and 2) the absence of nephrotoxicity, risk of hyperthyroidism and radiation exposure. The aim of our study is therefore to compare perfusion ultrasound with coronary angiography and MRI in this population so that, if the results are satisfactory, certain invasive examinations currently considered essential can be avoided.

Being tested
perfusion ultrasound
Keywords
acute coronary syndrome without ST segment elevation, emergency cardiology
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • perfusion ultrasoundOther

    During the examination, the power of the probe will be increased in order to assess myocardial perfusion.

    The contrast agent bubbles are destroyed by applying a 'flash', i.e. a temporary increase in the power of the ultrasound beam. Systole after systole, on a recorded loop, the filling velocity of the myocardium, which depends on myocardial blood flow, is analysed. The assessment of perfusion is visual and qualitative.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensitivity (SE) and specificity (SP), positive predictive value (PPV) and negative predictive value (NPV) (diagnosis obtained by consensus of two cardiologists based on all blinded examinations of the ultrasound results).

    Contrast-enhanced ultrasound (same measurements) according to recommendations, performed and interpreted by cardiologist 1, then reviewed and reinterpreted by the cardiologist.

    The reference diagnosis will be established by two cardiologists. The two cardiologists will therefore work blind to the examination being evaluated.

    Measured: inclusion visit

Secondary outcomes (1)
  1. Concordance between the diagnosis of TET from perfusion and the 'gold standard' (diagnosis obtained by consensus of two cardiologists based on all blinded examinations of the echo results). Kappa coefficient

    The two cardiologists will each give their diagnosis independently. If there's a disagreement between them, a third cardiologist (cardiologist number 5) will be called in to help, and the final decision will be made by majority vote.

    The two cardiologists will therefore work blind to the test being evaluated.

    Measured: visit inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2025
  2. Study start24 Jun 2024
  3. Primary completion31 Jul 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

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
Model description
prospective single-centre cohort study for diagnostic purposes
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07112820
Sponsor's protocol ID
APRICOT
Acronym
APRICOT
Status last verified
Aug 2025
First submitted
1 Aug 2025
Last updated
8 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing perfusion ultrasound in people with Myocardial Infarction (MI), run by Fondation Hôpital Saint-Joseph at 1 site in France.

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 8 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Contact Yoann MOEUF, medical doctor (+33 1 44 12 62 44, ymoeuf@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity (SE) and specificity (SP), positive predictive value (PPV) and negative predictive value (NPV) (diagnosis obtained by consensus of two cardiologists based on all blinded examinations of the ultrasound results). (time frame: inclusion visit). 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 8 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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