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Clinical Outcomes of Patients With Coronary Artery Disease

Clinical Outcomes of Patients With Coronary Artery Disease Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06216847
Acronym
COCAD
Enrollment
10000
Registered
2024-01-22
Start date
2024-02-21
Completion date
2030-10-31
Last updated
2025-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease (CHD)

Brief summary

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.

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.

Interventions

None listed

Sponsors

Shenyang Northern Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Ischemic eventsDuring 12-month follow updefined as the composite of cardiac death, myocardial infarction, or stroke

Secondary

MeasureTime frameDescription
Major adverse cardiovascular and cerebrovascular events (MACCE)During 1/2/3/4/5-year follow updefined as a composite of all-cause death, myocardial infarction, ischemic stroke and target-vessel revascularization
Cardiac deathDuring 1/2/3/4/5-year follow up
Stent thrombosisDuring 1/2/3/4/5-year follow up
Major bleeding eventsDuring 1/2/3/4/5-year follow updefined as BARC types 3 or 5 bleeding events
Clinical relevant bleeding eventsDuring 1/2/3/4/5-year follow updefined as BARC type 2-5 bleeding events

Countries

China

Contacts

Primary ContactYi Li, MD
doctorliyi@126.com+86-24-28897309
Backup ContactYaling Han, MD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026