Pulmonary Embolism AcuteNCT07616557
RDW and RV-PA Coupling in Acute PE
An observational study of Pulmonary Embolism Acute, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism Acute
- What is being tested?
- Echo-cardiography
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 15 Dec 2027
- 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: Adults, hemodynamically stable with acute pulmonary embolism
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
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.
- 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
- Conditions
- Pulmonary Embolism Acute
- Being tested
- Echo-cardiography
- Keywords
- Embolism, RDW, Right Ventricular-Pulmonary Arterial Coupling
- Medical subject headings
- Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echo-cardiographyOther
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
| Study group | Role | What they receive |
|---|---|---|
| Acute PE confirmed by computed tomography pulmonary angiogram (CTPA) performed within 24 h | Not described Receives: Other: Echo-cardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Embolism AcuteStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Prospective
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Entsar Hsanen, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616557
- Sponsor's protocol ID
- RDW and RV-PA Coupling in PE
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Admission Red Cell Distribution Width and Right Ventricular-Pulmonary Arterial Coupling in Acute Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT07616557
- Acronym / sponsor ID
- RDW and RV-PA Coupling in PE
- Conditions
- Pulmonary Embolism Acute
- Keywords
- Embolism, RDW, Right Ventricular-Pulmonary Arterial Coupling
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute PE confirmed by computed tomography pulmonary angiogram (CTPA) performed within 24 h | – | Other: Echo-cardiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults, hemodynamically stable with acute pulmonary embolism
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echo-cardiographyAll 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 | Other | Acute PE confirmed by computed tomography pulmonary angiogram (CTPA) performed within 24 h |
Primary outcome
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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism Acute, 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 2 inclusion and 8 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 Jun 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 Entsar Hsanen Mohamed, lecturer (+201019968106, entsar.hsanen@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2026.