- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ahmed A Abu Al-Abbass
- Phone Number: 0 10 03702766
- Email: ahmed.18313356@med.aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
6-month major adverse cardiovascular events (MACE)
Time Frame: 6 months
|
Composite of cardiac death, recurrent myocardial infarction, heart failure hospitalization, or life-threatening arrhythmia occurring within 6 months of admission.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Left atrial reservoir strain
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Hatem A Helmy, prof, Department of Cardiology, Faculty of Medicine, Assiut University
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LA-Strain-NSTEMI-2026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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