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NCT Number: NCT07676201

One-year Prognostic Impact of Microcirculation Assessed by NH IMR Angio in Patients Hospitalized for Acute Myocarditis

The goal of this observational study is to evaluate the association between post-coronary angiography IMR and medium-term clinical prognosis in patients with acute myocarditis. The main question it aims to answer is:

Is there a correlation between impaired microcirculation and the occurrence of serious clinical events in this population of patients?

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients over the age of 18.
  • Patients hospitalized between June 2015 and July 2025.
  • Patients who presented with chest pain and at least 1 diagnostic criterion; or, in the absence of chest pain, at least 2 of the following diagnostic criteria:
  • Electrocardiographic abnormalities (ST-segment elevation or depression, T-wave inversions, conduction disturbances such as type 3 atrioventricular block),
  • Elevated troponin levels,
  • Abnormal kinematics on echocardiography.
  • Associated with MRI findings of ≥2 tissue abnormalities (edema, hyperemia, myocardial fibrosis).
  • Coronary angiography performed during the initial hospitalization
  • Patient enrolled in or eligible for a social security program.
  • Patient who has expressed consent to participate.

Exclusion criteria

  • Absence of coronary artery disease confirmed by coronary angiography
  • Myocarditis secondary to immunotherapy
  • Presence of documented coronary artery disease (coronary angiography or cardiac CT)
  • Presence of cardiomyopathy (hypertrophic cardiomyopathy, dilated cardiomyopathy)
  • Infiltrative heart disease (sarcoidosis or cardiac amyloidosis)
  • Severe valvular heart disease
  • Takotsubo syndrome
  • Constrictive or chronic pericarditis
  • Loeffler's endocarditis
  • Left ventricular noncompaction
  • Cardiac tumor
  • Pulmonary embolism
  • Coronary spasm
  • Patients covered by Articles L1121-5 through L1121-8 of the Public Health Code (pregnant women, women in labor, and breastfeeding women; persons deprived of their liberty by judicial or administrative decision; adults under guardianship)

Treatment and study plan

Coronary catheterization

Procedure

Coronary catheterization

Primary outcomes

  1. MACE

    Time frame: From the time of the coronary angiography up to one year

    The primary endpoint is the 1-year incidence rate of MACE. MACE is defined by a composite endpoint comprising: 1) all-cause mortality, 2) cardiac decompensation requiring readmission, 3) heart transplantation, 4) documented sustained ventricular arrhythmia lasting >30 seconds, and 5) recurrence of myocarditis.

Secondary outcomes

  1. Individual components of the 12-month MACE: cardiovascular death, transplantation, hospitalization for heart failure, and persistent heart failure (reported separately)

    Time frame: From the time of the coronary angiography up to one year

  2. Correlation between IMR angiographic NH (continuous variable) and: a) MRI imaging criteria (LVEF, fibrosis, septal involvement, edema); b) biological markers (maximum troponin, CRP)

    Time frame: From the time of the coronary angiography up to one year

  3. Predictive value of MRI angiography: diagnostic performance in predicting the primary endpoint (ROC, optimal cut-off values, sensitivity/specificity)

    Time frame: From the time of the coronary angiography up to one year

  4. Assessment of inter- and intra-observer reproducibility of the MR angiography NH calculation (if a subsample is reanalyzed)

    Time frame: From the time of the coronary angiography up to one year

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: MICROMYOC

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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