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Clinical Trials/NCT03669991
NCT03669991
Unknown
Not Applicable

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

Chinese Academy of Medical Sciences, Fuwai Hospital1 site in 1 country2,200 target enrollmentAugust 31, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Coronary Syndrome
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Enrollment
2200
Locations
1
Primary Endpoint
Major adverse cardiovascular and cerebrovascular events (MACCE)
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 31, 2018
End Date
July 31, 2022
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Responsible Party
Principal Investigator
Principal Investigator

Yi-Da Tang

Professor

Chinese Academy of Medical Sciences, Fuwai Hospital

Eligibility Criteria

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.)

Outcomes

Primary Outcomes

Major adverse cardiovascular and cerebrovascular events (MACCE)

Time Frame: 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 Outcomes

  • Serum norepinephrine(Within 1 year after surgery)
  • Resting heart rate(Within 1 year after surgery)
  • Ejection fraction(Within 1 year after surgery)
  • Blood pressure (systolic & diastolic)(Within 1 year after surgery)

Study Sites (1)

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