Effect of PCI on Clinical Prognosis of Chronic Coronary Artery Occlusion

December 23, 2024 updated by: Chen Leilei, The First Affiliated Hospital with Nanjing Medical University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

258

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • The First Affiliated Hospital with Nanjing Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients were referred for PCI based on CTO-related symptoms or evidence of viability, or corresponding ischemia in the area of the CTO artery. The enrolled patients were divided into 2 groups, i.e., CTO-PCI group (n=187) and CTO-OMT group (n=46). The strategy to perform PCI on CTO patients was dependent on some factors, including co-morbidity, technical challenges, operators' preference

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CTO-PCI group
successful percutaneous coronary intervention (PCI)
Procedure: PCI
successful percutaneous coronary intervention (PCI) in Coronary chronic total occlusions (CTOs) patients
Other Names:
  • percutaneous coronary intervention
Drug: OMT
optimal medical therapy (OMT) in CTO patients, such as aspirin 1td, ACEI/ARB 1td, β blocker 1td, statin 1td.
Other Names:
  • optimal medical therapy
CTO-OMT group
optimal medical therapy (OMT)
Drug: OMT
optimal medical therapy (OMT) in CTO patients, such as aspirin 1td, ACEI/ARB 1td, β blocker 1td, statin 1td.
Other Names:
  • optimal medical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
major adverse cardiac cerebrovascular events (MACCE)
Time Frame: January 2011 to December 2023
including cardiac death, recurrent myocardial infarction, unplanned revascularization, and stroke.
January 2011 to December 2023

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all-cause death
Time Frame: January 2011 to December 2023
all-cause death
January 2011 to December 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Study Director: Leilei Chen, The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2023

Primary Completion (Actual)

September 17, 2024

Study Completion (Estimated)

September 17, 2025

Study Registration Dates

First Submitted

August 1, 2024

First Submitted That Met QC Criteria

August 3, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 23, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTO-PCI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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