Clinical trial NCT06137521: Risk Factors and Outcomes in Coronary Chronic Total Occlusion
Official title: Risk Factors and Outcomes in Patients With Stable Coronary Artery Disease and Coronary Chronic Total Occlusion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Total Occlusion
Coronary Artery Disease
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with coronary artery disease and CTO undergone coronary angiography at Ruijin Hospital, Shanghai, China will be consecutively enrolled.

Brief summary: This study aims to assess the risk factors and evaluate the long-term outcomes of patients with coronary chronic total occlusion (CTO) treated with percutaneous coronary intervention or medical treatment.

Detailed description: Coronary artery disease (CAD) is still one of the major contributors to global mortality. CTO is a special lesion type of CAD, defined as complete occlusion of at least one major epicardial coronary artery more than 3 months. Compared to non-CTO patients, those with CTO have worse prognosis. The prognosis of CTO patients is related to many factors including the baseline characteristics, modality of treatment and the degree of coronary collateral formation. Figuring out the factors which can indicate the outcomes of CTO is essential to clinical decision making. In this single center, observational study, we collect patient's clinical characteristics and blood samples to investigate potential factors associated with the development of coronary collateral formation and outcomes in patents with stable coronary artery disease.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years; Patients with angina or silent ischemia and documented ischemia; Patients with CTO ≥ 3months

Exclusion Criteria:

* eGFR\<15mL/(min·1.73m2); Chronic heart failure with NYHA grade ≥3; Had a history of coronary artery bypass grafting; Had received a percutaneous coronary intervention within the prior 3 months; Malignant tumor or immune system disorders; Pulmonary heart disease

Primary outcomes:
measure: The degree of collateral estimated visually by Rentrop score during coronary angiography
timeFrame: Immediate post-angiography
measure: Composite event of all-cause mortality, non-fatal myocardial infarction, heart failure and repeat revascularization
timeFrame: up to 5 years
Secondary outcomes:
measure: Event of all-cause mortality
timeFrame: up to 5 years
measure: Event of death from cardiac causes
timeFrame: up to 5 years
measure: Event of heart failure
timeFrame: up to 5 years
measure: The change of left ventricular ejection fraction
timeFrame: 1 year
measure: Events of repeat revascularization
timeFrame: up to 5 years
measure: Event rate of procedural success
timeFrame: Immediate post-PCI
measure: Event of procedural outcomes
timeFrame: 1 month post-angiography or PCI
Other outcomes:
measure: The level of serum markers and biochemical indexes which have been reported to closely related to cardiovascular diseases and collateral formation.
timeFrame: up to 5 years
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Study officials:
affiliation: Ruijin Hospital
name: Fenghua Ding, PhD, MD
role: STUDY_CHAIR
References: