Clinical Outcomes of Patients With Coronary Artery Disease (COCAD)

January 21, 2024 updated by: Han Yaling, Shenyang Northern Hospital

Clinical Outcomes of Patients With Coronary Artery Disease Cohort Study

Coronary heart disease (CHD) stands as a foremost contributor to global mortality, characterized by complex pathogenesis that renders conventional "one-size-fits-all" preventive strategies inefficient. Therefore, the investigators designed a prospective, multi-center cohort study among patients hospitalized due to either confirmed or suspected CHD, which aimed to establish a holographic data set for the diagnosis and treatment of CHD and explore the impact of critical therapeutic strategies in the real world on the clinical outcomes of CHD patients, providing evidence to optimize the management pathway.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Coronary heart disease (CHD) stands as a foremost contributor to global mortality. Despite the increasing investment in the prevention of risk factors and the popularization of percutaneous coronary intervention (PCI), the age-standardized incidence and mortality of CHD continue to increase. CHD is characterized by complex pathogenesis, rendering conventional "one-size-fits-all" preventive strategies inefficient.

Currently, there is a need to address two critical challenges. The first centers on early detection, precise risk stratification, and personalized intervention strategies for high-risk CHD patients, with a focus on the exploration of inflammation-driven risks, lesion-based risk stratification, and tailored anti-thrombotic therapies. The second challenge lies in the transformation of clinical risk assessment and decision-making processes into a precise level through the utilization of big data mining techniques.

Therefore, the investigators designed a prospective, multi-center cohort study among patients hospitalized due to either confirmed or suspected CHD, which aimed to establish a holographic data set for the diagnosis and treatment of CHD and explore the impact of critical therapeutic strategies in the real world on the clinical outcomes of CHD patients, providing evidence to optimize the management pathway.

Study Type

Observational

Enrollment (Estimated)

10000

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 Backup

  • Name: Yaling Han, MD

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110016
        • General Hospital of Northern Theater Command
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patients hospitalized due to either confirmed or suspected CHD

Description

Inclusion Criteria:

  • Age ≥ 18 years old
  • Hospitalization due to either confirmed or suspected CHD combined with one of the following features: previous PCI or CABG; previous myocardial infarction; previous coronary angiography revealing ≥ 50% stenosis in major coronary vessels; presentation with chest pain and pre-test probability of CHD > 65%; laboratory tests revealing objective evidence of myocardial ischemia; coronary CT angiography (CTA) showed ≥ 30% stenosis in major coronary vessels
  • Subjects undergoing at least one coronary imaging and one functional examination. Imaging examinations include coronary CTA, intravascular ultrasound (IVUS), or optical coherence tomography (OCT). Functional examination include fraction flow reservation (FFR), CT-FFR or quantitative flow ratio (QFR).
  • Written informed consent provided.

Exclusion Criteria:

  • History of mental illness, drug or alcohol abuse, or being unable to cooperate with follow-up visits for any reason;
  • Life expectancy <1 year
  • Pregnant or plan to be pregnant within 1 year
  • Subjects participating in any other clinical trial
  • Other conditions deemed unsuitable for inclusion by the investigator

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

Outcome Measure
Measure Description
Time Frame
Ischemic events
Time Frame: During 12-month follow up
defined as the composite of cardiac death, myocardial infarction, or stroke
During 12-month follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular and cerebrovascular events (MACCE)
Time Frame: During 1/2/3/4/5-year follow up
defined as a composite of all-cause death, myocardial infarction, ischemic stroke and target-vessel revascularization
During 1/2/3/4/5-year follow up
Cardiac death
Time Frame: During 1/2/3/4/5-year follow up
During 1/2/3/4/5-year follow up
Stent thrombosis
Time Frame: During 1/2/3/4/5-year follow up
During 1/2/3/4/5-year follow up
Major bleeding events
Time Frame: During 1/2/3/4/5-year follow up
defined as BARC types 3 or 5 bleeding events
During 1/2/3/4/5-year follow up
Clinical relevant bleeding events
Time Frame: During 1/2/3/4/5-year follow up
defined as BARC type 2-5 bleeding events
During 1/2/3/4/5-year follow up

Collaborators and Investigators

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

Sponsor

Shenyang Northern Hospital

Investigators

  • Principal Investigator: Yaling Han, MD, The General Hospital of Northern Theater Command

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

February 1, 2024

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2030

Study Registration Dates

First Submitted

January 11, 2024

First Submitted That Met QC Criteria

January 11, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 21, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COCAD V1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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