Risk Factors and Outcomes in Coronary Chronic Total Occlusion

Recruiting

• Conditions: Coronary Artery Disease; Chronic Total Occlusion
• Interventions: Procedure: Coronary angiography

• Registration Number: NCT06137521
• Lead Sponsor: Ruijin Hospital

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.

Study Timeline

• Study Start: 2010-01-01
• Status Verified: 2023-11
• Study First Submitted: 2023-11-13
• Study First Submitted QC: 2023-11-13
• Study First Posted: 2023-11-18
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18
• Primary Completion: 2026-12-31
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with good coronary collaterals	Coronary angiography	Coronary collateral circulation development was graded according to the Rentrop score, grade 2 (partial filling of the epicardial segment by collateral vessels); grade 3 (complete filling of the epicardial artery by collateral vessels) were defined as good coronary collateral circulation.
Patients with poor coronary collaterals	Coronary angiography	Coronary collateral circulation development was graded according to the Rentrop score, grade 0 (no filling of any collateral vessels) and grade 1 (filling of side branches of the artery to be perfused by collateral vessels without visualization of the epicardial segment) were defined as poor coronary collateral circulation.

Primary Outcome Measures

Name	Time	Method
The degree of collateral estimated visually by Rentrop score during coronary angiography	Immediate post-angiography	The 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 revascularization	up to 5 years

Secondary Outcome Measures

Name	Time	Method
Event of death from cardiac causes	up to 5 years
The change of left ventricular ejection fraction	1 year
Event of all-cause mortality	up to 5 years
Event of heart failure	up to 5 years
Event of procedural outcomes	1 month post-angiography or PCI
Events of repeat revascularization	up to 5 years
Event rate of procedural success	Immediate post-PCI

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China