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RDW and RV-PA Coupling in Acute PE

27. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Studietype

Observasjonsmessig

Registrering (Antatt)

190

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Adults, hemodynamically stable with acute pulmonary embolism

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Acute PE confirmed by computed tomography pulmonary angiogram (CTPA) performed within 24 h
Annen: Echo-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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Assiut University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. juni 2026

Primær fullføring (Antatt)

15. juni 2027

Studiet fullført (Antatt)

15. desember 2027

Datoer for studieregistrering

Først innsendt

21. mai 2026

Først innsendt som oppfylte QC-kriteriene

27. mai 2026

Først lagt ut (Faktiske)

1. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RDW and RV-PA Coupling in PE

Plan for individuelle deltakerdata (IPD)

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UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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