RDW and RV-PA Coupling in Acute PE
2026年5月27日 更新者：Entsar Hsanen、Assiut University
Association Between Admission Red Cell Distribution Width and Right Ventricular-Pulmonary Arterial Coupling in Acute Pulmonary Embolism
Prior work linking RDW to echocardiographic findings in PE has largely focused on isolated parameters such as TAPSE or PASP and has rarely incorporated modern measures of RV-PA coupling.
Whether admission RDW reflects the integrated RV-PA interaction - and not merely contractility or pressure in isolation - has not been adequately addressed.
Establishing this link would support RDW as a simple, universally available marker of RV vulnerability at first presentation, and would lay the groundwork for future prognostic and mechanistic studies.
研究概览
详细说明
Consecutive adults admitted via the emergency department or transferred to the participating center with confirmed acute PE will be screened by the study team.
Demographic and clinical
- Age, sex, body mass index and Smoking status.
- Comorbidities: hypertension, diabetes mellitus, coronary artery disease, heart failure, Chronic Obstructive Pulmonary Disease, chronic kidney disease, prior venous thromboembolism, active cancer, recent surgery, recent immobilization, history of COVID -19 infection and vaccination.
- Current medications relevant to erythropoiesis or hemodynamics (ACE inhibitors/ARBs, beta-blockers, diuretics, iron supplementation, erythropoiesis-stimulating agents, anticoagulants on admission).
Laboratory
- Complete blood count: hemoglobin, MCV, MCH, RDW-CV, RDW, white cell count and differential, platelet count, mean platelet volume.
- Renal and hepatic function: creatinine, eGFR, AST, ALT, total bilirubin.
- Cardiac biomarkers: high-sensitivity troponin. 3 Imaging
- CTPA: anatomic location of thrombus (main, lobar, segmental, subsegmental), presence of saddle embolus, RV/LV diameter ratio on axial imaging.
4.Echocardiography
All echocardiograms will follow a standardized acquisition protocol based on the American Society of Echocardiography and European Association of Cardiovascular Imaging recommendations for RV assessment. Key elements:
- Left lateral decubitus position when tolerated; semi-recumbent if dyspneic.
- ECG-gated digital loops of at least three consecutive cardiac cycles for each view.
- Mandatory views: parasternal long-axis and short-axis; apical four-chamber, RV-focused four-chamber, two-chamber, and three-chamber; subcostal four-chamber and IVC.
- M-mode through the lateral tricuspid annulus for TAPSE.
- Continuous-wave Doppler across the tricuspid valve for peak TR velocity (multiple windows attempted; agitated saline contrast may be used to improve TR signal at operator discretion).
- Tissue Doppler at the lateral tricuspid annulus for S'.
- Speckle-tracking acquisition optimized for RV strain (frame rate 50-80 fps). Studies will be acquired on a single ultrasound platform (or ≤2 platforms with documented inter-platform agreement) and analyzed offline using vendor-neutral software where possible. Studies failing image-quality criteria for the primary outcome will be flagged and the participant excluded from the primary analysis
研究类型
观察性的
注册 (估计的)
190
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Entsar Hsanen Mohamed, lecturer
- 电话号码：+201019968106
- 邮箱：entsar.hsanen@aun.edu.eg
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
Adults, hemodynamically stable with acute pulmonary embolism
描述
Inclusion Criteria:
Age ≥ 18 years. Acute PE confirmed by computed tomography pulmonary angiogram (CTPA) performed within 24 h of presentation.
CBC obtained within 24 h of admission and before any blood transfusion. Transthoracic echocardiography feasible within 24 h of admission. Written informed consent.
Exclusion Criteria:
- Active hematologic malignancy or recent chemotherapy with myelosuppressive intent.
- Red blood cell transfusion within the preceding 90 days.
- Known hemoglobinopathy (e.g., sickle cell disease, thalassemia major).
- Chronic dialysis or eGFR < 15 mL/min/1.73 m².
- Pre-existing severe pulmonary hypertension (resting mean PAP ≥ 35 mmHg by prior right heart catheterization or echocardiographic PASP ≥ 60 mmHg before this admission), severe left-sided valvular disease, or known severe biventricular dysfunction.
- Hemodynamic instability requiring vasopressors at the time of echocardiography, as their hemodynamics may distort RV-PA coupling estimates.
- Inadequate echocardiographic image quality precluding measurement of TAPSE and a quantifiable TR jet for PASP estimation.
- Inability to provide informed consent.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Acute PE confirmed by computed tomography pulmonary angiogram (CTPA) performed within 24 h
|
All echocardiograms will follow a standardized acquisition protocol based on the American Society of Echocardiography and European Association of Cardiovascular Imaging recommendations for RV assessment. Key elements:
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
assess the association between admission red cell distribution width (RDW) and right ventricular-pulmonary arterial coupling, measured by TAPSE/PASP ratio on transthoracic echocardiography performed within 24 hours of admission, in adults with acute PE
大体时间：24 hours
|
To assess the association between admission red cell distribution width (RDW) and right ventricular-pulmonary arterial coupling, measured by the TAPSE/PASP ratio on transthoracic echocardiography performed within 24 h of admission, in adults with acute pulmonary embolism
|
24 hours
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月15日
初级完成 (估计的)
2027年6月15日
研究完成 (估计的)
2027年12月15日
研究注册日期
首次提交
2026年5月21日
首先提交符合 QC 标准的
2026年5月27日
首次发布 (实际的)
2026年6月1日
研究记录更新
最后更新发布 (实际的)
2026年6月1日
上次提交的符合 QC 标准的更新
2026年5月27日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.