- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Ahmed A Abu Al-Abbass
- Telefonnummer: 0 10 03702766
- E-Mail: ahmed.18313356@med.aun.edu.eg
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
6-month major adverse cardiovascular events (MACE)
Zeitfenster: 6 months
|
Composite of cardiac death, recurrent myocardial infarction, heart failure hospitalization, or life-threatening arrhythmia occurring within 6 months of admission.
|
6 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Left atrial reservoir strain
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: Hatem A Helmy, prof, Department of Cardiology, Faculty of Medicine, Assiut University
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- LA-Strain-NSTEMI-2026
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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