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Risk Factors and Outcomes in Coronary Chronic Total Occlusion

Risk Factors and Outcomes in Patients With Stable Coronary Artery Disease and Coronary Chronic Total Occlusion

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06137521
Enrollment
3000
Registered
2023-11-18
Start date
2010-01-01
Completion date
2027-03-01
Last updated
2026-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Total Occlusion, Coronary Artery Disease

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.

Interventions

PROCEDURECoronary angiography

Sponsors

Ruijin Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
The degree of collateral estimated visually by Rentrop score during coronary angiographyImmediate post-angiographyThe degree of coronary collateralization supplying the distal area of the total coronary occlusion was visually graded using the Rentrop scoring system as follows: 0=no visible collaterals; 1=poorly opacified collaterals with faint visualization of the distal vessel; 2=partial filling of the collateral vessels; and 3=complete filling of the collateral vessels. Patients were then classified as poor coronary collaterals (Rentrop scores of 0 and 1) or good coronary collaterals (Rentrop scores of 2 and 3), according to the Rentrop score.
Composite event of all-cause mortality, non-fatal myocardial infarction, heart failure and repeat revascularizationup to 5 years

Secondary

MeasureTime frame
Event of all-cause mortalityup to 5 years
Event of death from cardiac causesup to 5 years
Event of heart failureup to 5 years
The change of left ventricular ejection fraction1 year
Events of repeat revascularizationup to 5 years
Event rate of procedural successImmediate post-PCI
Event of procedural outcomes1 month post-angiography or PCI

Countries

China

Contacts

CONTACTFenghua Ding, PhD, MD
ruijindfh@126.com0086 021 64370045
STUDY_CHAIRFenghua Ding, PhD, MD

Ruijin Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 19, 2026