- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Ahmed A Abu Al-Abbass
- 전화번호: 0 10 03702766
- 이메일: ahmed.18313356@med.aun.edu.eg
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
6-month major adverse cardiovascular events (MACE)
기간: 6 months
|
Composite of cardiac death, recurrent myocardial infarction, heart failure hospitalization, or life-threatening arrhythmia occurring within 6 months of admission.
|
6 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Left atrial reservoir strain
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
- 연구 의자: Hatem A Helmy, prof, Department of Cardiology, Faculty of Medicine, Assiut University
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- LA-Strain-NSTEMI-2026
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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