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Not yet recruitingNCT07616557Updated Jun 1, 2026

RDW and RV-PA Coupling in Acute PE

An observational study in Pulmonary Embolism Acute, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
190
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

Consecutive adults admitted via the emergency department or transferred to the participating center with confirmed acute PE will be screened by the study team.

  1. 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).
  2. 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
02

Conditions studied

  • Pulmonary Embolism Acute

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Keywords

  • Embolism
  • RDW
  • Right Ventricular-Pulmonary Arterial Coupling
03

In context

Embolism

104 studies on the registry are indexed under Embolism; 14 are open to participants now.

This study's planned enrollment of 190 is below the median of 500 across 41 observational studies indexed under Embolism.

Browse Embolism studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults, hemodynamically stable with acute pulmonary embolism

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

Exclusion Criteria:

  • Active hematologic 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 \< 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 .
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
190 participants (estimated)
Patient registry
No

Groups and cohorts

  • Acute PE confirmed by computed tomography pulmonary angiogram (CTPA) performed within 24 h

    Other: Echo-cardiography

Interventions

  • OtherEcho-cardiography

    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

06

What researchers measure

Primary outcomes

  1. 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

    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

    Time frame: 24 hours

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07616557
Lead sponsor
Assiut University
Responsible party
Entsar Hsanen (lecturer, Assiut University) — Principal investigator
First posted
Jun 1, 2026
Start date
Jun 15, 2026 (estimated)
Primary completion
Jun 15, 2027 (estimated)
Completion
Dec 15, 2027 (estimated)
Last update
Jun 1, 2026

Study contacts

Entsar Hsanen Mohamed, lecturer
Contact
entsar.hsanen@aun.edu.eg
+201019968106

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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