Transradial Selective Catheterization of the Celiac Artery in Obese Patients
25. november 2019 oppdatert av: Olivier F. Bertrand, Laval University
Transradial Selective Catheterization of the Celiac Artery in Obese Patients: A Pilot Study
BACKGROUND:
- Obesity, with its associated comorbidities, is set to become a major risk factor for cardiovascular disease in the 21st century. To this day, diet and medical therapy have proven only limited efficacy and bariatric surgery remains the last resort for many severely obese patients who wish to lose weight, modify their cardiovascular risk factors and ultimately modify their long-term prognosis. However, bariatric surgery remains associated with significant procedural morbidity and many patients are not eligible for such a surgery procedure as the risk-benefit ratio of bariatric surgery in severe obese patients with coronary artery disease is not yet well known.
- Recently, percutaneous left gastric artery embolization has been reported as a promising technique leading to a body weight loss that is equivalent to bariatric surgery.
- In the context of an endovascular procedure in obese patients, vascular access is a major concern. Transradial access (or radial artery approach) has been consistently associated with significant reductions in access-site related vascular complications and peri-procedural bleeding compared to the standard transfemoral access (or femoral artery approach). This is particularly evident in patients with severe obesity.
- Visceral arteries most often have an acute angulation with the aorta which makes them more easily cannulated from above (transradial access) compared to below (transfemoral access). Preliminary experience has shown that cannulation of the celiac artery is feasible from transfemoral and transradial access, the latter being associated with shorter procedural time and less contrast agent use. To date, several pilot studies have reported successful percutaneous embolization of the left gastric artery with biodegradable microspheres. This appears to be a promising technique to reduce weight in severely obese patients.
- Prior to launching a randomized trial, further study is warranted regarding the feasibility and safety aspects of transradial angiography of the celiac artery.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
RATIONALE:
- A significant proportion of patients referred to IUCPQ-UL catheterization laboratory are overweight (body mass index >25 kg/m²).
- Ongoing research and early clinical experience suggest that embolization of the left gastric artery could drastically reduce ghrelin levels and be associated with significant weight loss.
- In obese patients, catheterization using femoral artery access is associated with higher risks of vascular complications and peri-procedural bleeding compared to a radial artery approach.
- Given the anatomy (angle) of the celiac artery, selective catheterization of the celiac and left gastric arteries remains challenging, especially in obese patients.
- Before studying the effects of bariatric embolization, more data regarding the access of the left gastric artery is necessary.
HYPOTHESES:
- Transradial angiography of the celiac artery/left gastric artery is feasible and safe.
- Given the angulation of celiac artery, catheterization through a radial approach could be simpler.
- Selective angiography of the celiac artery and the left gastric artery can be performed in the setting of uncomplicated coronary angiography/percutaneous coronary intervention (PCI).
- Detailed anatomy of the celiac artery and its branches can be visualized by selective transradial angiography.
OBJECTIVES:
- The primary objective is to demonstrate the feasibility and safety of performing selective angiography of the celiac artery using a transradial approach in obese patients referred for diagnostic coronary angiography and/or PCI.
- The secondary objective is to observe anatomical variations of the celiac artery and the left gastric artery.
STUDY DESIGN:
> A prospective pilot study performed at Quebec Heart & Lung Institute (Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval; IUCPQ-UL).
Studietype
Intervensjonell
Registrering (Faktiske)
54
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Quebec
-
Quebec City, Quebec, Canada, G1V 4G5
- Quebec Heart & Lung Institute (IUCPQ-UL)
-
-
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
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Patients undergoing coronary angiography with a BMI >30 kg/m² will be eligible.
Exclusion Criteria:
- Kidney disease defined by a glomerular filtration rate less than 60 ml/min/m² according to the Modification of Diet in Renal Disease (MDRD) formula;
- Previous gastric or bariatric surgery;
- Emergency coronary procedure.
Furthermore, the procedure will be cancelled if one of the following criteria are met during the coronary angiography:
- Contrast volume >250 ml;
- Radiation dose >180 Gy.cm² as assessed by the dose area product (DAP).
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: Recruited patients
Transradial celiac artery angiography
|
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of successful selective angiographies
Tidsramme: Baseline
|
The primary end-point will be the percentage of successful selective angiographies of the celiac artery.
|
Baseline
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of complications of angiographies
Tidsramme: Baseline
|
As catheterization and angiography of the celiac artery is an endovascular procedure, the incidence of vessel trauma (such as dissection or perforation) during the procedure will be assessed.
All cine films will be reviewed by a multidisciplinary team.
|
Baseline
|
|
Procedure duration
Tidsramme: Baseline
|
Time (minutes) required to complete the angiography of the celiac artery
|
Baseline
|
|
Contrast volume
Tidsramme: Baseline
|
Volume (mL) of contrast required to complete the angiography of the celiac artery
|
Baseline
|
|
Radiation exposure (duration)
Tidsramme: Baseline
|
Fluoroscopy time (minutes) required to complete the angiography of the celiac artery
|
Baseline
|
|
Radiation exposure (dose)
Tidsramme: Baseline
|
Dose area product (Gy·cm2) required to complete the angiography of the celiac artery
|
Baseline
|
|
Number of catheters
Tidsramme: Baseline
|
The number of catheters required to complete the angiography of the celiac artery
|
Baseline
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Olivier F Bertrand, MD PhD, IUCPQ-UL and Laval 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 (Faktiske)
9. februar 2018
Primær fullføring (Faktiske)
31. mai 2019
Studiet fullført (Faktiske)
30. september 2019
Datoer for studieregistrering
Først innsendt
30. januar 2018
Først innsendt som oppfylte QC-kriteriene
9. februar 2018
Først lagt ut (Faktiske)
15. februar 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. november 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. november 2019
Sist bekreftet
1. november 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EASY-AngioBar
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
IPD-planbeskrivelse
To be completed
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. .