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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Chronic Total Occlusion
• Intervention / Treatment: Procedure: Coronary angiography

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 Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Fenghua Ding, PhD, MD; Phone Number: 0086 021 64370045; Email: ruijindfh@126.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
    • Contact: Jian Li; Phone Number: 0086 021 64370045; Email: ruijincrc@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with good coronary collaterals; 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.	Procedure: Coronary angiography
Patients with poor coronary collaterals; 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.	Procedure: Coronary angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite event of all-cause mortality, non-fatal myocardial infarction, heart failure and repeat revascularization		up to 5 years
The degree of collateral estimated visually by Rentrop score during coronary 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.	Immediate post-angiography

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
The level of serum markers and biochemical indexes which have been reported to closely related to cardiovascular diseases and collateral formation.	up to 5 years

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Study Chair: Fenghua Ding, PhD, MD, Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: RFOCTO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No