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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07676201
Acronym
MICROMYOC
Enrollment
106
Registered
2026-06-30
Start date
2026-07-15
Completion date
2026-10-15
Last updated
2026-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocarditis Acute

Keywords

NH IMR, Coronary catheterization

Brief summary

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

Coronary catheterization

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
MACEFrom the time of the coronary angiography up to one yearThe 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

MeasureTime frame
Individual components of the 12-month MACE: cardiovascular death, transplantation, hospitalization for heart failure, and persistent heart failure (reported separately)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)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)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)From the time of the coronary angiography up to one year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 1, 2026