Real World Assessment of Effects of Beta-blockers on Patients With Acute Coronary Syndrome

Real World Assessment of Effects of Beta-blockers on Patients With Acute Coronary

The study is aimed to optimized the dose-adjusted regimen of beta-blockers in patients with acute coronary syndrome by investigating therapeutic and curative results of target doses Beta-blockers using the dose-adjusted pathway of beta-blockers.

Study Overview

• Status: Unknown
• Conditions: Acute Coronary Syndrome

• Study Type: Observational
• Enrollment (Anticipated): 2200

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Recruiting
      • Fuwai Hospital, Chinese Academy of Medical Sciences
      • Contact: Yi-Da Tang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with acute coronary syndrome

Description

Inclusion Criteria:

• Age ≥ 18 years
• Patients diagnosed as acute coronary syndromes including acute ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevated acute coronary syndrome (NSTE-ACS)
• Patients or whose legal representatives signed written informed consent form

Exclusion Criteria:

Patients should been excluded if they meet any of the following exclusion criteria:

• Patients with contraindications to the application of beta blockers, including: 1) cardiogenic shock or heart failure (Killip grade > II level);2) sick sinus syndrome; 3) II degree atrioventricular block;4) unstable decompensation of cardiac failure (pulmonary edema, hypotension or low perfusion); 5) symptomatic hypotension or bradycardia (heart rate<50 beats/min, blood pressure<90/60mmHg); 6) contraindications to beta blockers or allergy to any ingredient of beta blocker; 7) active asthma should be treated by inhalation preparation treatment
• Pregnant or lactating women
• Patients without signed written informed consent
• Patients who was considered by the researcher inappropriate to participate in this study (for example, patients with a higher risk of cardiogenic shock, etc.)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiovascular and cerebrovascular events (MACCE)	MACCE were defined as a composite of all-cause death, myocardial infarction (MI), unplanned target vessel revascularization (TVR), stent thrombosis (ST) and stroke.	Within 1 year after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting heart rate	The resting heart rate of the body is the number of contractions of the heart that occur in a single minute while the body is at complete rest.	Within 1 year after surgery
Blood pressure (systolic & diastolic)	Blood pressure (BP) is the pressure of circulating blood on the walls of blood vessels.	Within 1 year after surgery
Ejection fraction	Ejection fraction (EF) is the volumetric fraction of fluid (usually blood) ejected from a chamber (usually the heart) with each contraction (or heartbeat).	Within 1 year after surgery
Serum norepinephrine	Norepinephrine is a neurotransmitter that is secreted in response to stress.	Within 1 year after surgery

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
• Investigators: Principal Investigator: Yi-Da Tang, MD, Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2018
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): July 31, 2022

Study Registration Dates

• First Submitted: September 3, 2018
• First Submitted That Met QC Criteria: September 12, 2018
• First Posted (Actual): September 13, 2018

Study Record Updates

• Last Update Posted (Actual): September 17, 2018
• Last Update Submitted That Met QC Criteria: September 13, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: 20181082

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No