NCT07616557

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P50-P75 for all trials

Timeline
18mo left

Started Jun 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

June 15, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2027

Last Updated

June 1, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

May 21, 2026

Last Update Submit

May 27, 2026

Conditions

Keywords

EmbolismRDWRight Ventricular-Pulmonary Arterial Coupling

Outcome Measures

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

    24 hours

Study Arms (1)

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

Other: Echo-cardiography

Interventions

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

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults, hemodynamically stable with acute pulmonary embolism

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Embolism

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Central Study Contacts

Entsar Hsanen Mohamed, lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

May 21, 2026

First Posted

June 1, 2026

Study Start

June 15, 2026

Primary Completion (Estimated)

June 15, 2027

Study Completion (Estimated)

December 15, 2027

Last Updated

June 1, 2026

Record last verified: 2026-05