Real World Assessment of Effects of Beta-blockers on Patients With Acute Coronary Syndrome
1 other identifier
observational
2,200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 31, 2018
CompletedFirst Submitted
Initial submission to the registry
September 3, 2018
CompletedFirst Posted
Study publicly available on registry
September 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2022
CompletedSeptember 17, 2018
September 1, 2018
3.3 years
September 3, 2018
September 13, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Resting heart rate
Within 1 year after surgery
Blood pressure (systolic & diastolic)
Within 1 year after surgery
Ejection fraction
Within 1 year after surgery
Serum norepinephrine
Within 1 year after surgery
Eligibility Criteria
Patients with acute coronary syndrome
You may qualify if:
- 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
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100037, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yi-Da Tang, MD
Chinese Academy of Medical Sciences, Fuwai Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 3, 2018
First Posted
September 13, 2018
Study Start
August 31, 2018
Primary Completion
December 31, 2021
Study Completion
July 31, 2022
Last Updated
September 17, 2018
Record last verified: 2018-09