NCT07112820

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress77%
Jun 2024Nov 2026

Study Start

First participant enrolled

June 24, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 8, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

2.1 years

First QC Date

August 1, 2025

Last Update Submit

August 1, 2025

Conditions

Keywords

acute coronary syndrome without ST segment elevationemergency cardiology

Outcome Measures

Primary Outcomes (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.

    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

    visit inclusion

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Paris Saint-Joseph

Paris, Ilede France, 75014, France

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Yoann MOEUF, medical doctor

    Hospital Paris Saint-Joseph

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoann MOEUF, medical doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: prospective single-centre cohort study for diagnostic purposes
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2025

First Posted

August 8, 2025

Study Start

June 24, 2024

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

August 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations