Acute Coronary SyndromeNCT03669991
Real World Assessment of Effects of Beta-blockers on Patients With Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 2,200 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2018to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute coronary syndrome
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100037
Yi-Da Tang
About this study
Official title: 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.
- Conditions
- Acute Coronary Syndrome
- Medical subject headings
- Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 1 year after surgery
Secondary outcomes (4)
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.
Measured: Within 1 year after surgery
Blood pressure (systolic & diastolic)
Blood pressure (BP) is the pressure of circulating blood on the walls of blood vessels.
Measured: Within 1 year after surgery
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).
Measured: Within 1 year after surgery
Serum norepinephrine
Norepinephrine is a neurotransmitter that is secreted in response to stress.
Measured: Within 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start31 Aug 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Da Tang, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Yi-Da Tang, MD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669991
- Sponsor's protocol ID
- 20181082
- Status last verified
- Sep 2018
- First submitted
- 3 Sep 2018
- Last updated
- 17 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Assessment of Effects of Beta-blockers on Patients With Acute Coronary
- ClinicalTrials.gov ID
- NCT03669991
- Acronym / sponsor ID
- 20181082
- Conditions
- Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 31 Aug 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute coronary syndrome
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Resting heart rate
Time frame: Within 1 year after surgery
Blood pressure (systolic & diastolic)
Time frame: Within 1 year after surgery
Ejection fraction
Time frame: Within 1 year after surgery
Serum norepinephrine
Time frame: Within 1 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Da Tang, MD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Yang, MD (+86-10-88396173, 13810727489@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular and cerebrovascular events (MACCE) (time frame: Within 1 year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2018.