Deep Learning-Based Automated Pressure-Strain Loop Analysis
Noninvasive left ventricular pressure-strain loop analysis estimates myocardial work from longitudinal strain, brachial systolic blood pressure, and cardiac valve-event timing. It provides global work index, constructive work, wasted work, and work efficiency.
This study evaluates a deep-learning method that automates myocardial work and loop-shape analysis. The method may reduce analysis time, improve reproducibility, and identify patterns associated with heart failure.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Håvard Dalen, Professor Havard Dalen, MD, Ph
- Telefonnummer: +4772828027
- E-post: havard.dalen@ntnu.no
Studiesteder
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Trondheim, Norge, 7006
- St. Olavs hospital
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Ta kontakt med:
- Ingrid Yttervoll, MD
- Telefonnummer: 90741665
- E-post: ingrid.yttervoll@ntnu.no
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
Heart failure participants:
- Age ≥18 years
- Able to provide informed consent
- Previous myocardial infarction
- Left ventricular ejection fraction ≤40% after myocardial infarction
Healthy volunteers:
- Age ≥18 years
- Able to provide informed consent
Exclusion Criteria:
Heart failure participants:
- Unstable disease
- Contraindication to exercise testing or echocardiography, as judged by an experienced cardiologist
Healthy volunteers:
- Hypertension
- Diabetes mellitus
- Dyslipidemia
- Current smoking
- Pregnancy
- Significant systemic disease
- Cardioactive medication affecting heart rate, myocardial contractility, or vascular tone
- Echocardiographic findings suggesting structural heart disease
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Participants With Heart Failure
Participants undergo echocardiography at rest, during sustained handgrip, and during semi-supine bicycle exercise. |
Participants perform sustained isometric handgrip at around 30 % of maximal voluntary contraction for 5 minutes during echocardiography. Participants perform graded semi-supine bicycle exercise during echocardiography. |
|
Eksperimentell: Healthy Volunteers
Healthy volunteers undergo echocardiography at rest, during sustained handgrip, and during semi-supine bicycle exercise. |
Participants perform sustained isometric handgrip at around 30 % of maximal voluntary contraction for 5 minutes during echocardiography. Participants perform graded semi-supine bicycle exercise during echocardiography. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Echocardiographic Acquisition Success
Tidsramme: During one study visit: at rest, during the handgrip and bicycle test.
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Percentage of acquired examinations successfully processed by the deep-learning pipeline to generate myocardial work indices, assessed separately at rest, during handgrip, and during bicycle exercise. |
During one study visit: at rest, during the handgrip and bicycle test.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Agreement Between Deep Learning- and Expert-Derived Myocardial Work Indices
Tidsramme: Echocardiograms acquired at rest and during handgrip and bicycle exercise at a single study visit.
|
Agreement for myocardial work indices will be assessed using mean bias with 95% limits of agreement, and mean absolute error. |
Echocardiograms acquired at rest and during handgrip and bicycle exercise at a single study visit.
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2019/1059_1
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Individual participant data sharing is not currently planned. Any future sharing would require appropriate ethical, institutional, and data-protection approvals.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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