Costs, Effectiveness, QALYs, and Efficiency of Bioabsorbable Devices in Daily Clinical Practice (REPARA-QALY)
29. juli 2016 opdateret af: Sección Hemodinamica y Cardiologia Intervencionista
REgistry of PAtients Treated With bioabsoRbable Devices in dAily Clinical Practice: Costs, Effectiveness, QALYs, and Efficiency. REPARA-QALY Registry
A multicenter, prospective, observational cohort study with clinical, quality of life, and economic evaluation to ascertain the quality-adjusted life years (QALYs) gained by patients with ischemic heart disease revascularized with Absorb in standard clinical practice in Spain.
A before-after comparative analysis will be performed, so that each patient will act as his/her own control.
Studieoversigt
Status
Ukendt
Intervention / Behandling
Detaljeret beskrivelse
Economical evaluation study of the efficiency of Absorb in a cohort of patients with ischemic heart disease who have undergone revascularization with Absorb based on the criteria established according to standard clinical practice. A comparison group without Absorb cannot be used for ethical reasons. Thus, each patient will act as his/her own control, and a before-after comparison will be done. This is therefore a prospective, observational cohort study with concurrent data collection.
Primary objective:
- To assess utility (QALYs gained) in patients implanted Absorb in standard clinical practice conditions.
Secondary objectives:
- To assess effectiveness (clinical outcomes) in patients who undergo coronary revascularization with Absorb implantation.
- To assess costs (direct and indirect) derived from coronary revascularization with Absorb implantation.
- To assess efficiency in terms of cost/utility (cost per QALY gained) and cost/effectiveness (cost per MACE -major cardiac adverse events- free patient).
Undersøgelsestype
Observationel
Tilmelding (Forventet)
1000
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Madrid, Spanien, 28041
- Rekruttering
- Hospital 12 de Octubre
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Kontakt:
- Felipe Hernandez, MD
- Telefonnummer: +34 913908440
- E-mail: felipeivus@hotmail.com
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Kontakt:
- Sandra Mayordomo, MD
- Telefonnummer: +34 913908440
- E-mail: sandrinimg@hotmail.com
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 95 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients with ischemic heart disease who have undergone percutaneous coronary revascularization with Absorb according to standard clinical practice.
One thousand revascularized patients will be recruited at 40 sites.
Beskrivelse
Inclusion Criteria:
- Age ranging from 18 and 95 years.
- Both sexes.
- Coronary revascularization with Absorb for any of the following lesions: de novo, restenosis, segment ST elevation myocardial infarction (STEMI), chronic total occlusion (CTO), trunk, venous graft, or bifurcations.
- Informed consent signed before participation in the study is started.
Exclusion Criteria:
- Pregnant or nursing woman..
- Cardiogenic shock.
- Refusal to participate in the study.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Coronary stenosis treated with Absorb
Patients with ischemic heart disease who have undergone percutaneous coronary revascularization with Absorb according to standard clinical practice.
One thousand revascularized patients will be recruited at 40 siteS.
|
Percutaneous coronary intervention
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Quality Adjusted Live Years (QALYs) gained since the first revascularization (the week before revascularization) to the end of follow-up (one year)
Tidsramme: 1 year follow-up
|
To construct QALYs, the EuroQoL-5D-3L (EQ-5D) will be used for the quality of life dimension, while the time elapsed between each EQ-5D measurement will be considered for the time dimension.
If a patient dies, the value of EQ-5D is 0 from the date of death.
|
1 year follow-up
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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"Target lesion failure", defined as cardiac death, target-vessel myocardial infarction, and target lesion ischemia at any time during the follow-up period.
Tidsramme: 1 year follow-up
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1 year follow-up
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Felipe Hernandez, MD, Hospital 12 de Octubre, Madrid
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2016
Primær færdiggørelse (Forventet)
1. december 2016
Studieafslutning (Forventet)
1. december 2017
Datoer for studieregistrering
Først indsendt
21. juli 2016
Først indsendt, der opfyldte QC-kriterier
29. juli 2016
Først opslået (Skøn)
3. august 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
3. august 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. juli 2016
Sidst verificeret
1. juli 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- COR-BVS-2016-01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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