Clinical trial NCT06216847: Clinical Outcomes of Patients With Coronary Artery Disease
Official title: Clinical Outcomes of Patients With Coronary Artery Disease Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Coronary Heart Disease (CHD)
Lead sponsor: Shenyang Northern Hospital
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients hospitalized due to either confirmed or suspected 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.

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

Primary outcomes:
measure: Ischemic events
timeFrame: During 12-month follow up
Secondary outcomes:
measure: Major adverse cardiovascular and cerebrovascular events (MACCE)
timeFrame: During 1/2/3/4/5-year follow up
measure: Cardiac death
timeFrame: During 1/2/3/4/5-year follow up
measure: Stent thrombosis
timeFrame: During 1/2/3/4/5-year follow up
measure: Major bleeding events
timeFrame: During 1/2/3/4/5-year follow up
measure: Clinical relevant bleeding events
timeFrame: During 1/2/3/4/5-year follow up
Other outcomes:
Locations:
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command
state: Liaoning
Study officials:
affiliation: The General Hospital of Northern Theater Command
name: Yaling Han, MD
role: PRINCIPAL_INVESTIGATOR
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