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NCT Number: NCT06137521

Risk Factors and Outcomes in 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.

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Key information

Conditions

Chronic Total Occlusion Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location status: Recruiting

Location contact

Jian Li

CONTACT

[email protected]

0086 021 64370045

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coronary Angiography

Procedure

Primary outcomes

  1. The degree of collateral estimated visually by Rentrop score during coronary angiography

    Time frame: 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.

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

    Time frame: up to 5 years

Secondary outcomes

  1. Event of all-cause mortality

    Time frame: up to 5 years

  2. Event of death from cardiac causes

    Time frame: up to 5 years

  3. Event of heart failure

    Time frame: up to 5 years

  4. The change of left ventricular ejection fraction

    Time frame: 1 year

  5. Events of repeat revascularization

    Time frame: up to 5 years

  6. Event rate of procedural success

    Time frame: Immediate post-PCI

  7. Event of procedural outcomes

    Time frame: 1 month post-angiography or PCI

Other outcomes

  1. The level of serum markers and biochemical indexes which have been reported to closely related to cardiovascular diseases and collateral formation.

    Time frame: up to 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Fenghua Ding, PhD, MD

CONTACT

[email protected]

0086 021 64370045

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2026
Study completion
2027
First posted
Nov 18, 2023
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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