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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03669991
• Other study ID #: 20181082
• Status: Recruiting
• Start date: August 31, 2018
• Est. completion date: July 31, 2022

Study information

• Verified date: September 2018
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Min Yang, MD
• Phone: +86-10-88396173
• Email: 13810727489[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2200
• Est. completion date: July 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Locations

Country	Name	City	State
China	Fuwai Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Blood pressure (systolic & diastolic)	Blood pressure (BP) is the pressure of circulating blood on the walls of blood vessels.	Within 1 year after surgery
Secondary	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
Secondary	Serum norepinephrine	Norepinephrine is a neurotransmitter that is secreted in response to stress.	Within 1 year after surgery