Risk Factors and Outcomes in Coronary Chronic Total Occlusion

NCT06137521 | Recruiting

• 1 other identifier: RFOCTO
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Total Occlusion; Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• 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

• Composite event of all-cause mortality, non-fatal myocardial infarction, heart failure and repeat revascularization

  up to 5 years

Secondary Outcomes (7)

• 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

Other Outcomes (1)

• 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

Study Arms (2)

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

Interventions

Coronary angiography PROCEDURE

Patients with good coronary collaterals; Patients with poor coronary collaterals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥18 years; Patients with angina or silent ischemia and documented ischemia; Patients with CTO ≥ 3months

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Fenghua Ding, PhD, MD

  Ruijin Hospital

  STUDY CHAIR

Central Study Contacts

Fenghua Ding, PhD, MD

CONTACT

0086 021 64370045; ruijindfh@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: January 1, 2010
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: November 18, 2024

Record last verified: 2023-11

Locations

CN (1)