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.
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)
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- 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.
France1 site, 1 recruiting
- Recruiting
Hospital Paris Saint-Joseph
Paris, Ilede France, 75014
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.
- Conditions
- Myocardial Infarction (MI)
- 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.
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)
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.
- First posted8 Aug 2025
- Study start24 Jun 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Infarction (MI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yoann MOEUF, medical doctor, Principal investigator, Hospital Paris Saint-Joseph
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07112820
- Acronym / sponsor ID
- APRICOT / APRICOT
- Conditions
- Myocardial Infarction (MI)
- Keywords
- acute coronary syndrome without ST segment elevation, emergency cardiology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- prospective single-centre cohort study for diagnostic purposes
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| perfusion ultrasoundDuring 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. | Other | – |
Primary outcome
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
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.
1 secondary outcome
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
Time frame: visit inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yoann MOEUF, medical doctor principal investigator
Hospital Paris Saint-Joseph
1 site in 1 country: see every site and its status.
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.