Clinical Outcomes of Patients With Coronary Artery Disease

Not yet recruiting

• Conditions: Coronary Heart Disease (CHD)

• Registration Number: NCT06216847
• Lead Sponsor: Shenyang Northern Hospital

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.

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-11
• Study First Submitted QC: 2024-01-11
• Last Update Submitted: 2024-01-21
• Study First Posted: 2024-01-22
• Last Update Posted: 2024-01-23
• Study Start: 2024-02-01
• Primary Completion: 2026-10-31
• Study Completion: 2030-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ischemic events	During 12-month follow up	defined as the composite of cardiac death, myocardial infarction, or stroke

Secondary Outcome Measures

Name	Time	Method
Major bleeding events	During 1/2/3/4/5-year follow up	defined as BARC types 3 or 5 bleeding events
Clinical relevant bleeding events	During 1/2/3/4/5-year follow up	defined as BARC type 2-5 bleeding events
Major adverse cardiovascular and cerebrovascular events (MACCE)	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
Cardiac death	During 1/2/3/4/5-year follow up
Stent thrombosis	During 1/2/3/4/5-year follow up

Trial Locations

Locations (1)

General Hospital of Northern Theater Command; 🇨🇳 Shenyang, Liaoning, China