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NCT Number: NCT06542653

Effect of PCI on Clinical Prognosis of Chronic Coronary Artery Occlusion

Coronary chronic total occlusions (CTOs) are considered to increase the risk of adverse clinical outcomes. The purpose of this study was to evaluate whether long-term clinical outcomes could be improved by successful percutaneous coronary intervention (PCI) over optimal medical therapy (OMT) in CTO patients.

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Key information

Conditions

Coronary Atheroscleroses Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

patients with CTO lesions undergoing PCI at the First Affiliated Hospital of Nanjing Medical University from January 2011 to December 2017 were enrolled. After someone were excluded due to CABG surgery, patients who met the enrollment criteria were divided into successful CTO-PCI group and CTO-OMT group based on the treatment received. The study primary endpoint was major adverse cardiac cerebrovascular events (MACCE), including cardiac death, recurrent myocardial infarction, unplanned revascularization, and stroke. The secondary endpoint was all-cause death.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with at least one coronary CTO lesion at our hospital in between January 2011 and December 2017

Exclusion criteria

  • (1) patients with ST-segment elevation myocardial infarction (STEMI)
  • (2)a history of coronary artery bypass grafting (CABG)
  • (3) cardiogenic shock
  • (4) malignant tumor. Patients were referred for PCI based on CTO-related symptoms or evidence of viability, or corresponding ischemia in the area of the CTO artery.

Treatment and study plan

PCI

Procedure

successful percutaneous coronary intervention (PCI) in Coronary chronic total occlusions (CTOs) patients

Other names: percutaneous coronary intervention

OMT

Drug

optimal medical therapy (OMT) in CTO patients, such as aspirin 1td, ACEI/ARB 1td, β blocker 1td, statin 1td.

Other names: optimal medical therapy

Primary outcomes

  1. major adverse cardiac cerebrovascular events (MACCE)

    Time frame: January 2011 to December 2023

    including cardiac death, recurrent myocardial infarction, unplanned revascularization, and stroke.

Secondary outcomes

  1. all-cause death

    Time frame: January 2011 to December 2023

    all-cause death

Study contacts

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

Lei Jiang

CONTACT

[email protected]

0086 18705501372

Mei Wang

CONTACT

[email protected]

0086 15256095215

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 7, 2024
Registry last updated
Dec 27, 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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