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Non-ST Elevation Myocardial Infarction (NSTEMI)NCT07797634

Left Atrial Strain for Predicting MACE in NSTEMI

An observational study of Non-ST Elevation Myocardial Infarction (NSTEMI) and Acute Coronary Syndrome, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This prospective observational study aims to evaluate whether left atrial reservoir strain, measured by two-dimensional speckle tracking echocardiography, independently predicts 6-month major adverse cardiovascular events (MACE) and provides incremental prognostic value beyond the GRACE 2.0 score, left ventricular… Read more about this study

Who is it for?
Ages 18 years and older
How many people
150 participants
Where
No sites listed yet
Study dates
26 Aug 2026to 25 May 2028
How long will I take part?
6 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients admitted with NSTEMI to the Cardiology Department / Coronary Care Unit of Assiut University Hospital who meet the eligibility criteria.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Known cardiomyopathy (hypertrophic, dilated, or infiltrative)
  • Pregnancy
  • Refusal to participate

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Ahmed A Abu Al-Abbass contact

0 10 03702766

ahmed.18313356@med.aun.edu.eg

About this study

Official title: 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

This prospective observational study aims to evaluate whether left atrial reservoir strain, measured by two-dimensional speckle tracking echocardiography, independently predicts 6-month major adverse cardiovascular events (MACE) and provides incremental prognostic value beyond the GRACE 2.0 score, left ventricular ejection fraction, and left atrial volume index in patients with non-ST-elevation myocardial infarction.

Read the 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.

Keywords
Left atrial strain, Reservoir strain, Speckle tracking echocardiography, GRACE score, Major adverse cardiovascular events, NSTEMI, Prognostic value
Medical subject headings
Non-ST Elevated Myocardial Infarction, Acute Coronary Syndrome, Myocardial Infarction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6-month major adverse cardiovascular events (MACE)

    Composite of cardiac death, recurrent myocardial infarction, heart failure hospitalization, or life-threatening arrhythmia occurring within 6 months of admission.

    Measured: 6 months

Secondary outcomes (4)

  1. Left atrial reservoir strain

    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.

    Measured: Baseline

  2. Change in risk discrimination with addition of LA reservoir strain

    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).

    Measured: 6 months

  3. Optimal cutoff value of LA reservoir strain

    Optimal cutoff value of left atrial reservoir strain for predicting 6-month MACE determined by receiver operating characteristic (ROC) curve analysis.

    Measured: 6 months

  4. Correlation of LA reservoir strain with clinical parameters

    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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2026
  2. Study start26 Aug 2026 (estimated)
  3. Primary completion26 Aug 2027 (estimated)
  4. Study completion25 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07797634
Sponsor's protocol ID
LA-Strain-NSTEMI-2026
Status last verified
Aug 2026
First submitted
26 Aug 2026
Last updated
1 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 31526253

  • 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.

    PubMed 35545531

  • 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.

    PubMed 32544032

  • 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.

    PubMed 38423888

Questions about this trial

What is this clinical trial studying?

An observational study of Non-ST Elevation Myocardial Infarction (NSTEMI) and Acute Coronary Syndrome, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ahmed A Abu Al-Abbass (0 10 03702766, ahmed.18313356@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-month major adverse cardiovascular events (MACE) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07797634, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.

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