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Impact of Guidelines on Cardiovascular and Economic Outcomes With Focus on Lipid Lowering Drugs (GuLLD)

23. november 2020 opdateret af: Gunilla Journath, Karolinska Institutet

Predicted Impact on Cardiovascular and Economic Outcomes of Swedish Atherosclerotic Cardiovascular Disease Guideline 2014 With Focus on Lipid Lowering Treatment

Methods: All patients <75 years registered in the Swedish Secondary Prevention after Heart Intensive care Admission registry (SEPHIA), will be followed-up within one year post-myocardia infarction (MI). The REACH risk prediction and a calibrated model for recurrent cardiovascular disease (CVD) events and death will be used to estimate base case, and calibrated CVD outcomes based on gender-specific risk factors. The predicted impact of the LDL-C reduction on the risk of CVD will be based on Cholesterol Treatment Trialists´ Collaboration findings.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

SWEDEHEART is a Swedish national registry consisting of several sub registries in which patients with acute coronary syndrome are prospectively registered. Patient characteristics, hospital treatments, drug treatments at discharge, and outcome for patients consecutively included and treated at all Swedish coronary care units are collected in this registry.SEPHIA is a sub registry collecting data on secondary prevention and cardiac rehabilitation. Follow-up are registered at six to ten weeks and at 12 to14 months post MI by office visits or phone. Around 80 % of all Swedish acute myocardial infarction (AMI) patients below the age of 75 years are included in this register.

In this study, a cohort of 5 904 (74% men) registered in the SEPHIA registry and who had one year follow-up during 2013, will be included. Data are aggregated and delivered from the SWEDEHEART/SEPHIA national registry. All patients were informed about their participation in the registry, the follow-up, and their right to decline participation. No written consent was obtained

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

5304

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

Ikke ældre end 74 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

a cohort of 5 904 (74% men) registered in the Swedish Secondary Prevention after Heart Intensive Care Admission (SEPHIA) registry and who have had one year follow-up during 2013

Beskrivelse

Inclusion Criteria: All patients with acute myocardial infarction registered in the SEPHIA registry and who had one year follow-up during 2013 -

Exclusion Criteria:none

-

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
Well-controlled cohort (LDL-C ≤ 1.8 mmol/L)
Individuals in the Swedish Secondary Prevention after Heart intensive care Admission (SEPHIA) is a sub register within SWEDEHEART collecting data on secondary prevention and cardiac rehabilitation with well-controlled LDL-cholesterol
Andet: Well-controlled
Both groups got treatment but well-controlled reached target of LDL-C<1.8 mmol/l
Andre navne:
  • Non-controlled
Non-controlled cohort
Individuals in the Swedish Secondary Prevention after Heart intensive care Admission (SEPHIA) is a sub register within SWEDEHEART collecting data on secondary prevention and cardiac rehabilitation and with not well-controlled LDL-C

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of AMI patients who have achieved target goal of LDL-cholesterol 1.8 mmol/L or not
Tidsramme: AMI patients with one year follow-up year 2013
Treatment gap will be analysed in well-controlled (LDL-C ≤1.8 mmol/L) and non-controlled ( LDL-C >1.8 mmol/L) cohort in men and women separately.
AMI patients with one year follow-up year 2013

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of predicted CVD events gained if target LDL-cholesterol was achieved in the non-controlled group
Tidsramme: Predicted number of events within a 10 year period
Number of events predicted to occur in the non-controlled group
Predicted number of events within a 10 year period
Health care costs in SEK saved, due to number of predicted CVD events gained if target LDL-cholesterol was achieved in the non-controlled group
Tidsramme: Predicted health care costs within a 10 year period
Health care costs predicted to be gained if the non-controlled group achieved target LDL-cholesterol
Predicted health care costs within a 10 year period

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Karolinska Institutet

Samarbejdspartnere

Uppsala University

Efterforskere

  • Ledende efterforsker: Gunilla Journath, PhD, Karolinska Institutet

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

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. januar 2015

Primær færdiggørelse (Faktiske)

1. januar 2016

Studieafslutning (Faktiske)

1. april 2016

Datoer for studieregistrering

Først indsendt

7. oktober 2016

Først indsendt, der opfyldte QC-kriterier

7. oktober 2016

Først opslået (Skøn)

11. oktober 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. november 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. november 2020

Sidst verificeret

1. november 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2015/4:7

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Kliniske forsøg med Well-controlled

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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