Clinical Performance and Quality Measures for Adults With Acute ST-Elevation Myocardial Infarction in China

October 8, 2019 updated by: China National Center for Cardiovascular Diseases
This study aims to investigate and evaluate clinical performance and quality measures for adults with acute ST-elevation myocardial infarction (STEMI) in China. Further more, the investigates like to develop quality improvement strategies and relevant tools focusing on treatment and clinical outcome in patients with STEMI. This is a annually survey , through consecutively recruiting all eligible inpatients and collecting relevant medical information, the performance of all participating hospitals. Further, quality improvement strategies including summary of clinical performance and quality measures, clinical pathways and team building will be organized for the purpose of quality improvement. All hospitals will consecutively recruit qualified patients in the same method adopted in baseline period. Then the reperfusion rates and other performance measures will be compared annually.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cardiovascular disease (CVD) is a major concern in public health globally, as well as in China, and remarkable variations of resources available and health system performance have been noted. Acute myocardial infarction is one of the leading causes of mortality and morbidity, both in rural and urban area.

This study aims to investigate and evaluate clinical performance and quality measures for adults with acute ST-elevation myocardial infarction (STEMI) in China. Further more, the investigates like to develop quality improvement strategies and relevant tools focusing on treatment and clinical outcome in patients with STEMI.

This is a annually survey , through consecutively recruiting all eligible inpatients and collecting relevant medical information, the performance of all participating hospitals. Demographic characteristics, clinical features, diagnostic tests, medications, procedures, and in-hospital outcomes of patients will be obtained and then, the treatment pattern and outcomes will be evaluated. Further, quality improvement strategies including summary of clinical performance and quality measures, clinical pathways and professional training will be organized for the purpose of quality improvement. All hospitals will consecutively recruit qualified patients in the same method adopted in baseline period. Then the reperfusion rates and other performance measures will be compared annually.

New knowledge will be generated about STEMI management in China, to improve STEMI patients prognosis in future.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200000

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Recruiting
        • Hongjian Wang
        • Contact:
        • Contact:
          • Yin Dong
          • Phone Number: 13552582795

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with STEMI who arrive at the hospital within 48 hours from the symptoms onset

Description

Inclusion Criteria:

  • Patients with STEMI who arrive at the hospital within 48 hours from the symptoms onset.

Exclusion Criteria:

  • None

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: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
All hospitals

All hospitals will take the treatment quality improvement strategies and tools into implementation.

Intervention: Behavioral: Quality improvement strategies and tools
Behavioral: Quality improvement strategies and tools
Quality improvement strategies and tools

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Aspirin at arrival
Time Frame: 24 hours after admission
Proportion of aspirin use within 24 hours of admission among eligible patients
24 hours after admission
Clopidogrel (or ticagrelor) at arrival
Time Frame: 24 hours after admission
Proportion of Clopidogrel (or ticagrelor) use within 24 hours of admission among eligible patients
24 hours after admission
β-blockers at arrival
Time Frame: 24 hours after admission
Proportion of β-blockers use within 24 hours of admission among eligible patients
24 hours after admission
ECG at arrival
Time Frame: 24 hours after admission
Proportion of ECG test within 10 minutes of admission among eligible patients
24 hours after admission
Reperfusion therapy rate
Time Frame: 24 hours after admission
Reperfusion therapy rate is defined as utilization rate of thrombolytic therapy or primary PCI treatment among patients indicated with the reperfusion therapy.
24 hours after admission
Time delay from failure of fibrinolysis to angiography(The time from start of fibrinolysis to evaluation of its efficacy is 60-90min)
Time Frame: 10 days on average (during hospitalization)
The proportion of failure of fibrinolysis to balloon within 90 minutes among all patients receiving PCI.
10 days on average (during hospitalization)
Time delay from start of fibrinolysis to angiography(if fibrinolysis is successful)
Time Frame: 10 days on average (during hospitalization)
The proportion of from fibrinolysis to balloon (if fibrinolysis is successful) within 2-24hours among all patients receiving PCI.
10 days on average (during hospitalization)
Timeliness of thrombolytic therapy
Time Frame: 24 hours after admission
The proportion of door to needle time (D2N) within 30 minutes among all patients receiving fibrinolytic therapy.
24 hours after admission
Timeliness of primary PCI
Time Frame: 24 hours after admission
The proportion of door to balloon (D2B) within 90 minutes among all patients receiving primary PCI.
24 hours after admission
Door-in-Door-Out Time
Time Frame: 24 hours after admission
Percentage of patients whose median time from the emergency department arrival at STEMI referral facility to emergency department discharge from STEMI referral facility is equal or less than 30 min. discharge from STEMI referral facility is 30 min.
24 hours after admission
Time to Primary PCI Among Transferred Patients
Time Frame: 24 hours after admission
Percentage of patients whose median time from first medical contact (at or before emergency department arrival to the STEMI referral facility [e.g., non-PCI-capable facility]) to primary PCI at the STEMI receiving facility (PCI-capable facility) is equal or less than 120 min
24 hours after admission
Evaluation of LDL-C
Time Frame: 10 days on average (during hospitalization)
Percentage of patients with documentation in the hospital record that LDL-C is evaluated during hospitalization
10 days on average (during hospitalization)
Evaluation of left ventricular ejection fraction
Time Frame: 10 days on average (during hospitalization)
Percentage of patients with documentation in the hospital record that left ventricular ejection fraction is evaluated during hospitalization
10 days on average (during hospitalization)
Aspirin use during hospitalization
Time Frame: 10 days on average (during hospitalization)
Proportion of Aspirin use during hospitalization among eligible patients.
10 days on average (during hospitalization)
Clopidogrel (or ticagrelor) use during hospitalization
Time Frame: 10 days on average (during hospitalization)
Proportion of Clopidogrel (or ticagrelor) use during hospitalization among eligible patients.
10 days on average (during hospitalization)
β-blockers use during hospitalization
Time Frame: 10 days on average (during hospitalization)
Proportion of β-blockers use during hospitalization among eligible patients.
10 days on average (during hospitalization)
Angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use during hospitalization
Time Frame: 10 days on average (during hospitalization)
Proportion of Angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use during hospitalization among eligible patients.
10 days on average (during hospitalization)
Statins use during hospitalization
Time Frame: 10 days on average (during hospitalization)
Proportion of statins use during hospitalization among eligible patients.
10 days on average (during hospitalization)
Aspirin use at discharge
Time Frame: 10 days on average (during hospitalization)
Proportion of aspirin use at discharge among eligible patients.
10 days on average (during hospitalization)
Clopidogrel (or ticagrelor) use at discharge
Time Frame: 10 days on average (during hospitalization)
Proportion of Clopidogrel (or ticagrelor) use at discharge among eligible patients.
10 days on average (during hospitalization)
β-blockers use at discharge
Time Frame: 10 days on average (during hospitalization)
Proportion of β-blockers use at discharge among eligible patients.
10 days on average (during hospitalization)
angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use at discharge
Time Frame: 10 days on average (during hospitalization)
Proportion of angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use at discharge among eligible patients.
10 days on average (during hospitalization)
Statins use at discharge
Time Frame: 10 days on average (during hospitalization)
Proportion of statins use at discharge among eligible patients.
10 days on average (during hospitalization)
Aldosterone Antagonist at Discharge
Time Frame: 10 days on average (during hospitalization)
Proportion of Aldosterone Antagonist use at discharge among eligible patients.
10 days on average (during hospitalization)
Smoking cessation advice/ counseling at Discharge
Time Frame: 10 days on average (during hospitalization)
Proportion of patients received smoking cessation advice/ counseling
10 days on average (during hospitalization)
all-cause mortality during hospitalization
Time Frame: 10 days on average (during hospitalization)
Proportion of patients who were all-cause death during hospitalization
10 days on average (during hospitalization)
Cardiac mortality during hospitalization
Time Frame: 10 days on average (during hospitalization)
Proportion of patients who were cardiac death during hospitalization
10 days on average (during hospitalization)
30-day all-cause mortality
Time Frame: From admission to 30days
Proportion of patients who were all-cause death from admission to 30days
From admission to 30days
30-day cardiac mortality
Time Frame: From admission to 30days
Proportion of patients who were cardiac death from admission to 30days
From admission to 30days
30-day readmission rates
Time Frame: From hospital discharge to 30 days
Proportion of patients readmission from hospital discharge to 30days
From hospital discharge to 30 days
Cost during hospitalization
Time Frame: 10 days on average (during hospitalization)
Cost during hospitalization
10 days on average (during hospitalization)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China National Center for Cardiovascular Diseases

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zhe Zheng, 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2035

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2035

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NCCQI-CAD

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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