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

NCT07676201 | Not Yet Recruiting

• 1 other identifier: 38RC26.0180
• Study Type: observational
• Target: 106
• Locations: 0 countries
• Sites: N/A

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?

Conditions

Myocarditis Acute

Keywords

NH IMR; Coronary catheterization

Outcome Measures

Primary Outcomes (1)

• MACE

  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 Outcomes (4)

• 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

Interventions

Coronary catheterization PROCEDURE

Coronary catheterization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 30, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06