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Real-world Use and Prognosis of Beta Blocker in Patients With Acute Coronary Syndrome in the Central China (UPB-ACS)

27. april 2020 opdateret af: Chuanyu Gao, Henan Institute of Cardiovascular Epidemiology

Real-world Use and Prognosis of Beta Blocker in Patients With Acute Coronary Syndrome in the Central China：a Prospective, Multicenter, Observational Research

Beta Blocker therapy is a mainstay of treatment following acute coronary syndromes (ACS), particularly acute myocardial infarction (MI). Studies have repeatedly demonstrated the benefit of Beta blocker therapy following either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation ACS,and Beta blocker therapy has been a performance measure used to grade hospital performance by the Centers for Medicare and Medicaid Services and Joint Commission on Accreditation of Healthcare Organizations.Although the benefit of Beta blocker therapy has been clearly demonstrated, the doses that have been used in many of these studies are significantly higher than those typically used currently in clinical practice.The benefit of Beta blockers has been ascribed to dose-related heart rate reduction,although alternative mechanisms for their benefit have also been proposed.In addition, the classical Beta blocker trials were performed decades ago, before the modern therapeutic era,which includes reperfusion therapy, potent antithrombotics, and statins. This raises the question of whether titration of Beta blocker therapy to the high doses that had been previously studied provides substantial incremental benefit in current clinical practice over the more frequently prescribed and clinically tolerated doses of Beta blockers.Moreover, a recent study has reported that high-dose Beta blockers were not superior to low-dose Beta blockers,aprovocative finding requiring validation. And until now, there has been no registry on patients with ACS about Between Beta-blocker Treatment in Henan, the most populated (about 100 million) and predominantly rural (66%)province in central China.

This multicenter, prospective, observational study is aimed to analyze the application status and long-term prognostic benefit of beta-blockers in patients with acute coronary syndrome.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

  1. Henan institute of cardiology epidemiology is responsible for design, data quality control and statistical analysis.
  2. Data were collected using a uniformed Case Report Form(CRF) by trained staff at each hospital.
  3. Sample size estimation: Based on retrospective observational cohort of ACS patients, 1-year mortality in beta-blocker recipients and non-beta-blocker recipients were 2.5% and 5.6%, respectively. To achieve a precision of 5% with an α of 0.05, the loss ratio of following-up is 15%.The investigators would need a sample of 3000.
  4. Statistical analysis plan: the investigators will report summary statistics for patient characteristics, comorbidities, treatment strategies and outcomes. the investigators will also undertake the following prespecified subgroup analyses: age, sex, STE-ACS or NSTE-ACS, history of diabetes, history of hypertension, smoking.and analyze the association Between Beta-blocker Treatment and Long-term Mortality.
  5. Quality assurance plan 1)Diagnosis of ACS is according to the third universal definition.2)Before registry, a training program on study objectives, data collection, and ACS management is given to the primary investigator and related staff at each participating center.3)Henan institute of cardiology epidemiology will regularly monitored at least 10% of CRFs for accuracy against medical records. If the CRFs are not completed with 98% accuracy, all CRFs are considered unqualified and this staff will be retrained.4)Before entering into the computer, data is queried for invalid and illogical values by research staff in Henan institute of cardiology epidemiology. Participating centres who has the high error rate of data, and no change in 6 months shall be deemed abandoned automatically; participating centres who has the high quality of data will be issued a certificate to reward.5)Investigator meeting will be annually held to conclude the progress, solve existing problems and strengthen program training.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

3000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Henan
      • Zhengzhou, Henan, Kina, 450000
        • Henan Province People's Hospital

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Anticipated 40 eligible sites in Henan province will participate. Each site will enroll patients who meet the inclusion criteria consecutively.

Beskrivelse

Inclusion Criteria:

  1. Age≥18 years.
  2. Patients with clinical evidence of acute coronary syndrome, including ST segment elevation myocardial infarction (STEMI), non ST segment elevation myocardial infarction (NSTEMI) and unstable angina.
  3. Informed consent signed by patients or legal guardians.

Exclusion Criteria:

  • Expected survival <12 months

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Major adverse cardiovascular and cerebrovascular events
Tidsramme: 1 year
including all-caused death, nonfatal- myocardial infarction,and stroke
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Major adverse cardiovascular and cerebrovascular events
Tidsramme: At discharge(an average of 10 days),6 month
including all-caused death, nonfatal- myocardial infarction,and stroke
At discharge(an average of 10 days),6 month
Coronary revascularization
Tidsramme: 6 month,1 year
including PCI,CABG,and PTCA
6 month,1 year
Re-hospitalized
Tidsramme: 6 month,1 year
Including hospitalization due to heart disease and noncardiac disease
6 month,1 year
Bleeding
Tidsramme: At discharge(an average of 10 days),6 month,1 year
according to GUSTO bleeding grade(excluding hemorrhage stroke)
At discharge(an average of 10 days),6 month,1 year
Recurrent angina
Tidsramme: At discharge(an average of 10 days)
Recurrent angina during hospitalization
At discharge(an average of 10 days)
the aggravation of Angina pectoris
Tidsramme: 6 month,1 year
Angina pectoris graded of CCS(CanadianCardiovascularSociety) rating at least one level
6 month,1 year
New arrhythmia
Tidsramme: At discharge(an average of 10 days)，6 month,1 year
including atrial fibrillation，thoracicoutletsyndrome，ventricular fibrillation，sick sinus syndrome，grade atrioventricular block and so on
At discharge(an average of 10 days)，6 month,1 year

Samarbejdspartnere og efterforskere

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

Sponsor

Henan Institute of Cardiovascular Epidemiology

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 (Faktiske)

1. marts 2017

Primær færdiggørelse (Faktiske)

26. april 2020

Studieafslutning (Faktiske)

26. april 2020

Datoer for studieregistrering

Først indsendt

12. april 2017

Først indsendt, der opfyldte QC-kriterier

12. april 2017

Først opslået (Faktiske)

17. april 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. april 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. april 2020

Sidst verificeret

1. april 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HenanICE201701

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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