Risk Factors and Outcomes in Coronary Chronic Total Occlusion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Coronary angiography.
- Who it may be relevant to
- Registry conditions: Chronic Total Occlusion, Coronary Artery Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Risk Factors and Outcomes in Patients With Stable Coronary Artery Disease and Coronary Chronic Total Occlusion
Overview
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.
Interventions
- Procedure Coronary angiography
Primary outcome measures
- The degree of collateral estimated visually by Rentrop score during coronary angiography [Time frame: Immediate post-angiography]
- Composite event of all-cause mortality, non-fatal myocardial infarction, heart failure and repeat revascularization [Time frame: up to 5 years]
Secondary outcome measures (7)
- Event of all-cause mortality [Time frame: up to 5 years]
- Event of death from cardiac causes [Time frame: up to 5 years]
- Event of heart failure [Time frame: up to 5 years]
- The change of left ventricular ejection fraction [Time frame: 1 year]
- Events of repeat revascularization [Time frame: up to 5 years]
- Event rate of procedural success [Time frame: Immediate post-PCI]
- Event of procedural outcomes [Time frame: 1 month post-angiography or PCI]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai
Identifiers
NCT: NCT06137521 · RFOCTO