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Clinical Trials/NCT06216847
NCT06216847
Recruiting
N/A

Clinical Outcomes of Patients With Coronary Artery Disease Cohort Study

Shenyang Northern Hospital1 site in 1 country10,000 target enrollmentFebruary 21, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Coronary Heart Disease (CHD)
Sponsor
Shenyang Northern Hospital
Enrollment
10000
Locations
1
Primary Endpoint
Ischemic events
Status
Recruiting
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 21, 2024
End Date
October 31, 2030
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Shenyang Northern Hospital
Responsible Party
Principal Investigator
Principal Investigator

Han Yaling

Prof.

Shenyang Northern Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Ischemic events

Time Frame: During 12-month follow up

defined as the composite of cardiac death, myocardial infarction, or stroke

Secondary Outcomes

  • Major bleeding events(During 1/2/3/4/5-year follow up)
  • Clinical relevant bleeding events(During 1/2/3/4/5-year follow up)
  • Major adverse cardiovascular and cerebrovascular events (MACCE)(During 1/2/3/4/5-year follow up)
  • Cardiac death(During 1/2/3/4/5-year follow up)
  • Stent thrombosis(During 1/2/3/4/5-year follow up)

Study Sites (1)

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