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Effect of PCI on Clinical Prognosis of Chronic Coronary Artery Occlusion

NCT ID: NCT06542653

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

258 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-17

Study Completion Date

2025-09-17

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Atheroscleroses

Keywords

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Chronic total occlusion Percutaneous coronary intervention Major adverse cardiovascular events

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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CTO-PCI group

successful percutaneous coronary intervention (PCI)

PCI

Intervention Type PROCEDURE

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

OMT

Intervention Type DRUG

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

CTO-OMT group

optimal medical therapy (OMT)

OMT

Intervention Type DRUG

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

Interventions

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PCI

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

Intervention Type PROCEDURE

OMT

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

Intervention Type DRUG

Other Intervention Names

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percutaneous coronary intervention optimal medical therapy

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Chen Leilei

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leilei Chen

Role: STUDY_DIRECTOR

The First Affiliated Hospital with Nanjing Medical University

Locations

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The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Mei Wang

Role: CONTACT

Phone: 0086 15256095215

Email: [email protected]

Lei Jiang

Role: CONTACT

Phone: 0086 18705501372

Email: [email protected]

Facility Contacts

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Lei Jiang

Role: primary

Mei Wang

Role: backup

Other Identifiers

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CTO-PCI

Identifier Type: -

Identifier Source: org_study_id