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

NCT07112820 · tracked via the Priya Life Science France tracker

Sponsor

Fondation Hôpital Saint-Joseph

Phase

Not applicable

Started

2024-06-24

Last updated

2025-08-08

Condition(s) studied

Myocardial Infarction (MI)

Investigational drug(s) / intervention(s)

perfusion ultrasound

perfusion ultrasound: 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.

Study 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 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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 Exclusion Criteria: 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) * 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)

Primary outcome measure(s)

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). — 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.

Trial sites (1)

Facility	City	Region	Status
Hospital Paris Saint-Joseph	Paris	Ilede France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07112820 on ClinicalTrials.gov ↗ ← All trials in France