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

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT03669991
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-31
• Status Verified: 2018-09
• Study First Submitted: 2018-09-03
• Study First Submitted QC: 2018-09-12
• Study First Posted: 2018-09-13
• Last Update Submitted: 2018-09-13
• Last Update Posted: 2018-09-17
• Primary Completion: 2021-12-31
• Study Completion: 2022-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Serum norepinephrine	Within 1 year after surgery	Norepinephrine is a neurotransmitter that is secreted in response to stress.
Resting heart rate	Within 1 year after surgery	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.
Ejection fraction	Within 1 year after surgery	Ejection fraction (EF) is the volumetric fraction of fluid (usually blood) ejected from a chamber (usually the heart) with each contraction (or heartbeat).
Blood pressure (systolic & diastolic)	Within 1 year after surgery	Blood pressure (BP) is the pressure of circulating blood on the walls of blood vessels.

Trial Locations

Locations (1)

Fuwai Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China