Risk Factors and Outcomes in Coronary Chronic Total Occlusion

Sponsor
Ruijin Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06137521
Collaborator
(none)
3,000
1
205.9
14.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
3000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Risk Factors and Outcomes in Patients With Stable Coronary Artery Disease and Coronary Chronic Total Occlusion
Actual Study Start Date :
Jan 1, 2010
Anticipated Primary Completion Date :
Dec 31, 2026
Anticipated Study Completion Date :
Mar 1, 2027

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. The degree of collateral estimated visually by Rentrop score during coronary angiography [Immediate post-angiography]

  2. Composite event of all-cause mortality, non-fatal myocardial infarction, heart failure and repeat revascularization [up to 5 years]

Secondary Outcome Measures

  1. Event of all-cause mortality [up to 5 years]

  2. Event of death from cardiac causes [up to 5 years]

  3. Event of heart failure [up to 5 years]

  4. The change of left ventricular ejection fraction [1 year]

  5. Events of repeat revascularization [up to 5 years]

  6. Event rate of procedural success [Immediate post-PCI]

  7. Event of procedural outcomes [1 month post-angiography or PCI]

Other Outcome Measures

  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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai China

Sponsors and Collaborators

  • Ruijin Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ruijin Hospital
ClinicalTrials.gov Identifier:
NCT06137521
Other Study ID Numbers:
  • RFOCTO
First Posted:
Nov 18, 2023
Last Update Posted:
Nov 18, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2023