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NCT Number: NCT03116854

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

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Henan province people's hospital

Zhengzhou, Henan, 450000, China

About this study

  • Henan institute of cardiology epidemiology is responsible for design, data quality control and statistical analysis.
  • Data were collected using a uniformed Case Report Form(CRF) by trained staff at each hospital.
  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age≥18 years.
  • 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.
  • Informed consent signed by patients or legal guardians.

Exclusion criteria

  • Expected survival <12 months

Treatment and study plan

Primary outcomes

  1. Major adverse cardiovascular and cerebrovascular events

    Time frame: 1 year

    including all-caused death, nonfatal- myocardial infarction,and stroke

Secondary outcomes

  1. Major adverse cardiovascular and cerebrovascular events

    Time frame: At discharge(an average of 10 days),6 month

    including all-caused death, nonfatal- myocardial infarction,and stroke

  2. Coronary revascularization

    Time frame: 6 month,1 year

    including PCI,CABG,and PTCA

  3. Re-hospitalized

    Time frame: 6 month,1 year

    Including hospitalization due to heart disease and noncardiac disease

  4. Bleeding

    Time frame: At discharge(an average of 10 days),6 month,1 year

    according to GUSTO bleeding grade(excluding hemorrhage stroke)

  5. Recurrent angina

    Time frame: At discharge(an average of 10 days)

    Recurrent angina during hospitalization

  6. the aggravation of Angina pectoris

    Time frame: 6 month,1 year

    Angina pectoris graded of CCS(CanadianCardiovascularSociety) rating at least one level

  7. New arrhythmia

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Henan Institute of Cardiovascular Epidemiology

Other

Registry information

Official study title

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

Acronym: UPB-ACS

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 17, 2017
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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