China Diabetes Cardiovascular Initiative (CDCV)

August 31, 2021 updated by: Dong ZHAO, Beijing Institute of Heart, Lung and Blood Vessel Diseases
As a collaborative project between American Heart Association, Chinese Society of Cardiology, American Diabetes Association and Chinese Diabetes Society, the China Diabetes Cardiovascular Initiative aims to enhance the attention and awareness of cardiovascular health care professionals (HCPs) in the managements of cardiovascular diseases and diabetes, to reduce diabetes-related complication and minimize adverse events in patients with cardiovascular disease, and to reduce the risk of cardiovascular morbidity and mortality in diabetic patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet 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.

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.
9600

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.

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

Non-Probability Sample

Study Population

Patients hospitalized with acute coronary syndrome and diabetes from 40 tertiary hospitals from China.

Description

Inclusion Criteria:

  1. Patients hospitalized with acute coronary syndrome and diabetes.
  2. Aged at least 18 years.

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

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
Time Frame
Proportion of patients receiving dual antiplatelet therapy at arrival (within 24 hours)
Time Frame: Duration of hospital stay, an expected average of 1 week
Duration of hospital stay, an expected average of 1 week
Proportion of STEMI patients receiving fibrinolytic therapy within 30 minutes after arrival among those receiving this treatment
Time Frame: Duration of hospital stay, an expected average of 1 week
Duration of hospital stay, an expected average of 1 week
Proportion of STEMI patients receiving reperfusion therapy by PCI
Time Frame: Duration of hospital stay, an expected average of 1 week
Duration of hospital stay, an expected average of 1 week
Proportion of STEMI patients receiving primary PCI within 90 minutes after arrival among those receiving this treatment
Time Frame: Duration of hospital stay, an expected average of 1 week
Duration of hospital stay, an expected average of 1 week
Proportion of NSTE-ACS patients receiving early cardiac troponin measurement (within 6 hours of arrival)
Time Frame: Duration of hospital stay, an expected average of 1 week
Duration of hospital stay, an expected average of 1 week
Proportion of NSTE-ACS patients receiving risk stratification at admission
Time Frame: Duration of hospital stay, an expected average of 1 week
Duration of hospital stay, an expected average of 1 week
Proportion of NSTE-ACS patients receiving PCI within recommended times for patients with high or intermediate risk
Time Frame: Duration of hospital stay, an expected average of 1 week
Duration of hospital stay, an expected average of 1 week
Proportion of patients prescribed dual antiplatelet medications at discharge
Time Frame: Duration of hospital stay, an expected average of 1 week
Duration of hospital stay, an expected average of 1 week
Proportion of patients with indications prescribed a beta-blocker at discharge
Time Frame: Duration of hospital stay, an expected average of 1 week
Duration of hospital stay, an expected average of 1 week
Proportion of patients prescribed a statin at discharge
Time Frame: Duration of hospital stay, an expected average of 1 week
Duration of hospital stay, an expected average of 1 week
Proportion of patients with indications prescribed an ACE-I or ARB at discharge
Time Frame: Duration of hospital stay, an expected average of 1 week
Duration of hospital stay, an expected average of 1 week
Proportion of patients that receiving an LDL-C assessment
Time Frame: Duration of hospital stay, an expected average of 1 week
Duration of hospital stay, an expected average of 1 week
Proportion of patients with evaluation for LV systolic function by echocardiography
Time Frame: Duration of hospital stay, an expected average of 1 week
Duration of hospital stay, an expected average of 1 week
Proportion of smoking patients that receiving smoking cessation advice/counseling
Time Frame: Duration of hospital stay, an expected average of 1 week
Duration of hospital stay, an expected average of 1 week
Proportion of patients receiving fasting glucose test at least twice
Time Frame: Duration of hospital stay, an expected average of 1 week
Duration of hospital stay, an expected average of 1 week
Proportion of patients receiving HbA1C test
Time Frame: Duration of hospital stay, an expected average of 1 week
Duration of hospital stay, an expected average of 1 week
Proportion of patients prescribed a SGLT-2 inhibitor or a GLP-1 receptor agonist at discharge with cardiovascular disease benefit
Time Frame: Duration of hospital stay, an expected average of 1 week
Duration of hospital stay, an expected average of 1 week
Proportion of patients with body height and weight measured and documented
Time Frame: Duration of hospital stay, an expected average of 1 week
Duration of hospital stay, an expected average of 1 week
Proportion of patients receiving guidance on individualized dietary
Time Frame: Duration of hospital stay, an expected average of 1 week
Duration of hospital stay, an expected average of 1 week
Proportion of patients receiving guidance on individualized physical activity
Time Frame: Duration of hospital stay, an expected average of 1 week
Duration of hospital stay, an expected average of 1 week

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.
Beijing Institute of Heart, Lung and Blood Vessel Diseases

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.
September 1, 2021

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, 2023

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, 2023

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).
August 31, 2021

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.
August 31, 2021

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 8, 2021

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.
September 8, 2021

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.
August 31, 2021

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.
August 1, 2021

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.
  • CDCV2021

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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