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

June 23, 2026 updated by: University Hospital, Grenoble

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients hospitalized in the cardiology department at CHUGA between 2015 and 2025 who had a diagnosis of myocarditis confirmed by cardiac MRI.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the time of the coronary angiography up to one year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
From the time of the coronary angiography up to one year
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
From the time of the coronary angiography up to one year
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
From the time of the coronary angiography up to one year
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
From the time of the coronary angiography up to one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 15, 2026

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

October 15, 2026

Study Registration Dates

First Submitted

June 23, 2026

First Submitted That Met QC Criteria

June 23, 2026

First Posted (Actual)

June 30, 2026

Study Record Updates

Last Update Posted (Actual)

June 30, 2026

Last Update Submitted That Met QC Criteria

June 23, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 38RC26.0180

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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