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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 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

3000

Kontakter og plasseringer

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

Studiesteder

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

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

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

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

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

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

Sponsor

Henan Institute of Cardiovascular Epidemiology

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)

1. mars 2017

Primær fullføring (Faktiske)

26. april 2020

Studiet fullført (Faktiske)

26. april 2020

Datoer for studieregistrering

Først innsendt

12. april 2017

Først innsendt som oppfylte QC-kriteriene

12. april 2017

Først lagt ut (Faktiske)

17. april 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. april 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. april 2020

Sist bekreftet

1. april 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HenanICE201701

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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