Risk Factors and Outcomes in Coronary Chronic Total Occlusion

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06137521
• Other study ID #: RFOCTO
• Status: Recruiting
• Start date: January 1, 2010
• Est. completion date: March 1, 2027

Study information

• Verified date: November 2023
• Source: Ruijin Hospital
• Contact: Fenghua Ding, PhD, MD
• Phone: 0086 021 64370045
• Email: ruijindfh[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: March 1, 2027
• Est. primary completion date: December 31, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Total Occlusion
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Coronary angiography

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	The degree of collateral estimated visually by Rentrop score during coronary angiography		Immediate post-angiography
Primary	Composite event of all-cause mortality, non-fatal myocardial infarction, heart failure and repeat revascularization		up to 5 years
Secondary	Event of all-cause mortality		up to 5 years
Secondary	Event of death from cardiac causes		up to 5 years
Secondary	Event of heart failure		up to 5 years
Secondary	The change of left ventricular ejection fraction		1 year
Secondary	Events of repeat revascularization		up to 5 years
Secondary	Event rate of procedural success		Immediate post-PCI
Secondary	Event of procedural outcomes		1 month post-angiography or PCI