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Not yet recruiting NCT07676201

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

— Observational Myocarditis Acute

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Coronary catheterization.
Who it may be relevant to
Registry conditions: Myocarditis Acute. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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?

Interventions

  • Procedure Coronary catheterization
    Coronary catheterization

Primary outcome measures

  • MACE [Time frame: From the time of the coronary angiography up to one year]
Secondary outcome measures (4)
  • 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]
  • 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]
  • 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]
  • 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07676201 · 38RC26.0180

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗