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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03669991
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Yi-Da Tang, 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.

Condition or disease
Acute Coronary Syndrome

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Study Type : Observational
Estimated Enrollment : 2200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real World Assessment of Effects of Beta-blockers on Patients With Acute Coronary
Actual Study Start Date : August 31, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : July 31, 2022



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. Serum norepinephrine [ Time Frame: Within 1 year after surgery ]
    Norepinephrine is a neurotransmitter that is secreted in response to stress.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with acute coronary syndrome
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669991


Contacts
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Contact: Min Yang, MD +86-10-88396173 13810727489@163.com
Contact: Kuo Zhang, MD +86-18813019602 kzhang23@outlook.com

Locations
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China, Beijing
Fuwai Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100037
Contact: Yi-Da Tang         
Sponsors and Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital
Investigators
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Principal Investigator: Yi-Da Tang, MD Chinese Academy of Medical Sciences, Fuwai Hospital
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Responsible Party: Yi-Da Tang, Professor, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT03669991    
Other Study ID Numbers: 20181082
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases