Clinical Features, Treatment Mode and Health Outcomes of Chest Pain Patients in China (CHANGE) (CHANGE)

July 9, 2019 updated by: China Cardiovascular Association

Clinical Features, Treatment Mode and Health Outcomes of Chest Pain Patients in China: China Chest Pain Center Accreditation Programme,CHANGE-chest Pain Research

Chinese Cardiovascular Association is an association dedicated to establishing Chest Pain Centers in hospitals that have basic qualifications and meet pre-designed quality control targets.The vision of Chinese Cardiovascular Association is the cardiovascular health of every Chinese, and the mission is to realize the early arrival of the inflection point of cardiovascular events in China.The institute of China Heart House is responsible for the daily management and implementation of Chinese Cardiovascular Association and the implementation and management of the Chest Pain Center construction project.In order to improve standard treatment and chest pain system management to achieve better outcomes for patients, China Heart House established the chest pain center database.The database includes patients in 4129 registered hospitals in 31 provinces in China who have been admitted with chest pain.The database can reflect the clinical characteristics, treatment and outcome of patients with chest pain in China.

This non-interventional, retrospective study analyzed the chest pain center database to understand the demographics, clinical characteristics, treatment patterns and clinical outcomes of patients with chest pain, and to analyze the effects of different treatment patterns, including chest pain centers and related collaborative treatment networks.The results of the study will assess the gap between the real-world situation and the recommendations of the guidelines and reflect the effect of chest pain centers and related collaborative treatment networks on the treatment process and service quality.The research results can be directly translated into the basis of medical treatment system intervention, and also provide decision-making reference for improving the certification standards and quality control of chest pain centers.

Study Overview

Status

Status

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

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.

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.
50000

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

The study population was inpatients (18 years and older) admitted to the Chest Pain Central database with symptoms of chest pain.The database registration of this study was conducted in 4129 registered hospitals in 31 provinces in China.All hospitals participating in the Chest Pain Center program are encouraged to manage patients in accordance with local standard practices (as recommended by current Chinese guidelines).

This study will include data on all patients in the chest pain central database.

Description

Inclusion Criteria:

  • age 18 and above
  • patients admitted with chest pain
  • diagnosis is made by the treating physician based on local practice and clinical judgment

Exclusion Criteria:

  • No

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

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.
Patients with Myocardial Infarction

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
mean and standard deviation of STEMI (ST-segment elevated Myocardial Infarction)patients
Time Frame: baseline
mean and standard deviation of STEMI patients
baseline
Proportion of STEMI (ST-segment elevated Myocardial Infarction)patients
Time Frame: baseline
Proportion of female STEMI patients
baseline
emergency information of STEMI patients
Time Frame: baseline

Path to hospital

First medical contact time

Does the patient circumvent emergency

Telecardiogram transmission

STEMI Reperfusion Therapy

Initiation time of interventional surgery

Catheter chamber activation time

Time of arrival of patient in catheter room

Guide wire passage time

D2B time
baseline
admission status of STEMI patients
Time Frame: baseline
admission status of STEMI patients
baseline
hospitalization evaluation of STEMI patients
Time Frame: baseline
value of serum troponin and serum creatinin of STEMI patients
baseline
In-hospital mortality of STEMI patients
Time Frame: baseline
In-hospital mortality of STEMI patients
baseline
Hospitalization days of STEMI patients
Time Frame: baseline
Hospitalization days of STEMI patients
baseline
Total cost of STEMI patients
Time Frame: baseline
Total cost of STEMI patients
baseline

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 Cardiovascular Association

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Peking University
Peking University First Hospital
Shanghai Zhongshan 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 (Anticipated)

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 1, 2019

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.
August 1, 2019

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.
August 1, 2019

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).
July 3, 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.
July 9, 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.
July 10, 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.
July 10, 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.
July 9, 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.
July 1, 2019

More Information

Terms related to this study

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.
  • GUSU19005

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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