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

NCT03116854 | Completed DMC

• 1 other identifier: HenanICE201701
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Coronary Syndrome

Keywords

Acute Coronary Syndrome; Beta Blockers; Prognosis

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular and cerebrovascular events

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

  1 year

Secondary Outcomes (7)

• Major adverse cardiovascular and cerebrovascular events

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

• Coronary revascularization

  6 month,1 year

• Re-hospitalized

  6 month,1 year

• Bleeding

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

• Recurrent angina

  At discharge(an average of 10 days)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Expected survival \<12 months

Sponsors & Collaborators

• Henan Institute of Cardiovascular Epidemiology: lead

Study Sites (1)

Henan province people's hospital

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: April 17, 2017
• Study Start: March 1, 2017
• Primary Completion: April 26, 2020
• Study Completion: April 26, 2020
• Last Updated: April 28, 2020

Record last verified: 2020-04

Locations

CN (1)