- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03669991
Real World Assessment of Effects of Beta-blockers on Patients With Acute Coronary Syndrome
September 13, 2018 updated by: Yi-Da Tang, Chinese Academy of Medical Sciences, Fuwai Hospital
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
Study Type
Observational
Enrollment (Anticipated)
2200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Min Yang, MD
- Phone Number: +86-10-88396173
- Email: 13810727489@163.com
Study Contact Backup
- Name: Kuo Zhang, MD
- Phone Number: +86-18813019602
- Email: kzhang23@outlook.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100037
- Recruiting
- Fuwai Hospital, Chinese Academy of Medical Sciences
-
Contact:
- Yi-Da Tang
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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)
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.
|
Within 1 year after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resting heart rate
Time Frame: 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.
|
Within 1 year after surgery
|
Blood pressure (systolic & diastolic)
Time Frame: Within 1 year after surgery
|
Blood pressure (BP) is the pressure of circulating blood on the walls of blood vessels.
|
Within 1 year after surgery
|
Ejection fraction
Time Frame: 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).
|
Within 1 year after surgery
|
Serum norepinephrine
Time Frame: Within 1 year after surgery
|
Norepinephrine is a neurotransmitter that is secreted in response to stress.
|
Within 1 year after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yi-Da Tang, MD, Chinese Academy of Medical Sciences, Fuwai Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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