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A Novel Automated & Comprehensive Approach for Ventricular Function Assessment in Heart Failure

4. april 2018 oppdatert av: National Heart Centre Singapore

Curvedness-based Imaging: A Novel Automated & Comprehensive Approach for Ventricular Function Assessment in Heart Failure

Heart failure is a major health care burden. It can occur with either normal or reduced LV ejection fraction, depending on different degrees of ventricular remodelling. The investigators recently published a new method, curvedness-based imaging. The investigators have also reported the diagnostic utility of curvedness-based imaging in various cardiac diseases. The investigators now propose to prospectively assess curvedness-based imaging for diagnosis of heart failure with normal ejection fraction and with reduced ejection fraction, and examine left ventricular systolic and diastolic function and predicts the prognosis in a cohort of HF patients.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

Heart failure imposes major global health care burden on society and suffering for the individual.In the US, HF affects 5.7 million patients, and is the leading cause of hospitalization for people over 65 years, with 25% to 50% rate or hospital readmission within 6 months.In Singapore, between 1991 and 1998, it accounted for 4.5% of all hospital admissions and 2.5% of mortality in the geriatric age group.It confers an annual mortality of 10%.

The early diagnosis and identification of the underlying etiology of HF is of paramount importance; some causes require specific treatment and may be correctable. From updated American College of Cardiology/American Heart Association guidelines, some questions must be addressed for suspected HF patients: Is the left ventricular ejection fraction preserved or reduced? Is the structure of the LV normal or abnormal? Are there other structural abnormalities such as right ventricular (RV) abnormalities that could account for the clinical presentation? Is there LV global and regional dysfunction and to what extent? Is the etiology ischemic or non-ischemic?

Cardiac imaging is important both for HF diagnosis and monitoring of progress. Impaired pump function, expressed reduced left ventricular ejection fraction is often used as a marker of HF. About 50% of HF have preserved EF.In this situation, more intricate and comprehensive imaging involving measurement of multiple diastolic and systolic parameters, usually using echocardiography, may become necessary to address the questions mentioned above.

Our solution is expected to result in a significant cost saving for HF patients. HF diagnosis is still very challenging, consisting of assessment of medical and family histories, a physical exam and diagnostic imaging tests. The investigators compare the cost difference in traditional way against our proposed solution. The traditional diagnostic tests include chest x-ray, BNP blood test, echocardiography, nuclear heart scan and cardiac catheterization. In this project, the investigators estimate the cost of echocardiography, nuclear heart scan and cardiac catheterization for HF diagnosis. Based on clinical experience, among 1000 patients undergoing echocardiography, 50% will be referred to nuclear heart scan and 30% will be referred to invasive cardiac catheterization. The cost of the whole workup is estimated to be $1.95 million. If 1000 patients undergo our proposed CBI solution directly, the cost estimated at $1.4 million. The cost saving is estimated at S$400 per patient.

Hence, the investigators will be exploring the following for this study:

Primary aim: Assess LV systolic and diastolic function from curvedness-based imaging in 120 HF patients with reduced ejection fraction and normal ejection fraction.

Secondary aim: Evaluate the utility of curvedness-based imaging for the diagnosis of etiology of HF, against gold standard gadolinium enhanced CMR in subgroup of HF patients.

Exploratory aim: Evaluate the utility of curvedness-based imaging for the prediction of prognosis during 6 month follow up, where clinical outcome include death, CV death and HF re-admission.

Studietype

Observasjonsmessig

Registrering (Faktiske)

78

Kontakter og plasseringer

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

Studiesteder

      • Singapore, Singapore, 169609
        • National Heart Centre Singapore

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

21 år til 90 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients presented to hospital with a primary diagnosis of Heart Failure or are attending a hospital clinic for management of Heart Failure within 6 months of an episode of decompensated heart failure, which either resulted in a hospital admission (primary diagnosis) or was treated in out-patient clinic

Beskrivelse

Inclusion Criteria:

  • Patients presented to hospital with a primary diagnosis of Heart Failure or are attending a hospital clinic for management of Heart Failure within 6 months of an episode of decompensated heart failure, which either resulted in a hospital admission (primary diagnosis) or was treated in out-patient clinic.
  • Written informed consent obtained

Exclusion Criteria:

  • Aged < 21 years
  • Contraindication to CMR examination.
  • Cardiac pacemaker
  • Brain aneurysm or clips
  • Electronic implants or prosthesis
  • Eye metal foreign body injury
  • Severe claustrophobia
  • Severe renal impairment, glomerular filtration rate < 30ml/min/1.73m2
  • Non-cardiac illness with life expectancy of less than 2 years
  • Previous heart, kidney, liver or lung transplantation.
  • HF primary due to severe valve disease
  • Other specific subgroups of HF: Including constrictive pericarditis, complex adult congenital heart disease, hypertrophic cardiomyopathy, eosinophilic myocarditis, cardiac amyloid and acute chemotherapy-induced cardiomyopathy.
  • Isolated right heart failure. Combined right and left heart failure will be included; Secondary to severe lung disease or pulmonary hypertension.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Kohort
  • Tidsperspektiver: Potensielle

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Heart Failure

Patients presented to hospital with a primary diagnosis of Heart Failure or are attending a hospital clinic for management of Heart Failure within 6 months of an episode of decompensated heart failure, which either resulted in a hospital admission (primary diagnosis) or was treated in out-patient clinic.

Cardiovascular Magnetic Resonance and Echocardiogram will be performed.

For evaluering av venstre ventrikkels volum, funksjon og masse. Dette er også for vurdering av myokardfibrose basert på forsinket forbedringsavbildningsteknikk.
For vurdering av diastolisk og systolisk funksjon samt klaffe- og hjertefunksjon. Ventrikulær-arteriell kobling vil også bli utført.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Allergic reaction due to MRI contrast
Tidsramme: Within first day of scan
Within first day of scan

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Hovedetterforsker: Ru San Tan, MD, National Heart Centre Singapore

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

1. november 2013

Primær fullføring (Faktiske)

1. august 2017

Studiet fullført (Faktiske)

1. august 2017

Datoer for studieregistrering

Først innsendt

31. mai 2016

Først innsendt som oppfylte QC-kriteriene

31. mai 2016

Først lagt ut (Anslag)

6. juni 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. april 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. april 2018

Sist bekreftet

1. september 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2013/934/C

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

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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