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- Essai clinique NCT07797634
Left Atrial Strain for Predicting MACE in NSTEMI
Incremental Prognostic Value of Left Atrial Reservoir Strain Beyond the GRACE 2.0 Score and Conventional Echocardiographic Parameters for Predicting 6-Month MACE in Patients With NSTEMI
Aperçu de l'étude
Statut
Description détaillée
Non-ST-elevation myocardial infarction (NSTEMI) carries significant short- and long-term risk of major adverse cardiovascular events despite advances in management. Current risk stratification relies on clinical scores such as GRACE 2.0 and conventional echocardiographic parameters including left ventricular ejection fraction (LVEF) and left atrial volume index (LAVI). These tools have limitations, as LVEF may remain preserved and LAVI mainly reflects chronic remodeling.
Left atrial (LA) reservoir strain assessed by two-dimensional speckle tracking echocardiography is a sensitive marker of left ventricular filling pressure and diastolic function. Reduced LA reservoir strain has been associated with adverse outcomes after NSTEMI, but data on its incremental prognostic value beyond established risk models remain limited.
This prospective observational study will assess whether LA reservoir strain independently predicts 6-month MACE and improves risk discrimination when added to the GRACE 2.0 score and conventional echocardiographic parameters in patients with NSTEMI.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ahmed A Abu Al-Abbass
- Numéro de téléphone: 0 10 03702766
- E-mail: ahmed.18313356@med.aun.edu.eg
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Age > 18 years
- Confirmed diagnosis of NSTEMI according to current ESC/ACC guidelines
- Willingness to provide informed consent and complete 6-month follow-up
- Undergoing coronary angiography or revascularization during the index hospitalization
Exclusion Criteria:
- ST-elevation myocardial infarction (STEMI)
- Atrial fibrillation or other significant arrhythmia at presentation
- Moderate to severe valvular heart disease (especially mitral valve disease)
- Prior cardiac surgery or valve replacement
- Poor echocardiographic image quality precluding reliable strain analysis
- Chronic kidney disease on dialysis
- Known cardiomyopathy (hypertrophic, dilated, or infiltrative)
- Pregnancy
- Refusal to participate
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
6-month major adverse cardiovascular events (MACE)
Délai: 6 months
|
Composite of cardiac death, recurrent myocardial infarction, heart failure hospitalization, or life-threatening arrhythmia occurring within 6 months of admission.
|
6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Left atrial reservoir strain
Délai: Baseline
|
Peak atrial longitudinal strain (PALS) during the reservoir phase measured by two-dimensional speckle tracking echocardiography (EchoPAC software), expressed as percentage (%).
Higher values indicate better left atrial function.
|
Baseline
|
|
Change in risk discrimination with addition of LA reservoir strain
Délai: 6 months
|
Change in risk discrimination for 6-month MACE when left atrial reservoir strain is added to the GRACE 2.0 score, left ventricular ejection fraction (LVEF), and left atrial volume index (LAVI), assessed by change in C-statistic, Net Reclassification Improvement (NRI), and Integrated Discrimination Improvement (IDI).
|
6 months
|
|
Optimal cutoff value of LA reservoir strain
Délai: 6 months
|
Optimal cutoff value of left atrial reservoir strain for predicting 6-month MACE determined by receiver operating characteristic (ROC) curve analysis.
|
6 months
|
|
Correlation of LA reservoir strain with clinical parameters
Délai: Baseline
|
Correlation between left atrial reservoir strain (expressed as percentage) and the following parameters: GRACE 2.0 score, peak troponin level (ng/L), left ventricular ejection fraction (%), and E/e' ratio.
Correlation will be assessed using Pearson or Spearman correlation coefficient.
|
Baseline
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Hatem A Helmy, prof, Department of Cardiology, Faculty of Medicine, Assiut University
Publications et liens utiles
Publications générales
- Schuster A, Backhaus SJ, Stiermaier T, Navarra JL, Uhlig J, Rommel KP, Koschalka A, Kowallick JT, Lotz J, Gutberlet M, Bigalke B, Kutty S, Hasenfuss G, Thiele H, Eitel I. Left Atrial Function with MRI Enables Prediction of Cardiovascular Events after Myocardial Infarction: Insights from the AIDA STEMI and TATORT NSTEMI Trials. Radiology. 2019 Nov;293(2):292-302. doi: 10.1148/radiol.2019190559. Epub 2019 Sep 17.
- Iwahashi N, Gohbara M, Kirigaya J, Abe T, Horii M, Hanajima Y, Toya N, Takahashi H, Kimura Y, Minamimoto Y, Okada K, Matsuzawa Y, Hibi K, Kosuge M, Ebina T, Tamura K, Kimura K. Prognostic Significance of the Combination of Left Atrial Reservoir Strain and Global Longitudinal Strain Immediately After Onset of ST-Elevation Acute Myocardial Infarction. Circ J. 2022 Sep 22;86(10):1499-1508. doi: 10.1253/circj.CJ-21-0907. Epub 2022 May 10.
- Leng S, Ge H, He J, Kong L, Yang Y, Yan F, Xiu J, Shan P, Zhao S, Tan RS, Zhao X, Koh AS, Allen JC, Hausenloy DJ, Mintz GS, Zhong L, Pu J. Long-term Prognostic Value of Cardiac MRI Left Atrial Strain in ST-Segment Elevation Myocardial Infarction. Radiology. 2020 Aug;296(2):299-309. doi: 10.1148/radiol.2020200176. Epub 2020 Jun 16.
- Beyls C, Hermida A, Nicolas M, Debrigode R, Vialatte A, Peschanski J, Bunelle C, Fournier A, Jarry G, Landemaine T, Malaquin D, Kubala M, Mahjoub Y, Leborgne L. Left atrial strain analysis and new-onset atrial fibrillation in patients with ST-segment elevation myocardial infarction: A prospective echocardiography study. Arch Cardiovasc Dis. 2024 Apr;117(4):266-274. doi: 10.1016/j.acvd.2024.01.002. Epub 2024 Feb 15.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- LA-Strain-NSTEMI-2026
Informations sur les médicaments et les dispositifs, documents d'étude
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