Effect of PCI on Clinical Prognosis of Chronic Coronary Artery Occlusion

NCT06542653 | Recruiting

• 1 other identifier: CTO-PCI
• Study Type: observational
• Target: 258
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Atheroscleroses

Keywords

Chronic total occlusion; Percutaneous coronary intervention; Major adverse cardiovascular events

Outcome Measures

Primary Outcomes (1)

• major adverse cardiac cerebrovascular events (MACCE)

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

  January 2011 to December 2023

Secondary Outcomes (1)

• all-cause death

  January 2011 to December 2023

Study Arms (2)

CTO-PCI group

successful percutaneous coronary intervention (PCI)

Procedure: PCI; Drug: OMT

CTO-OMT group

optimal medical therapy (OMT)

Drug: OMT

Interventions

PCI PROCEDURE

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

Also known as: percutaneous coronary intervention

CTO-PCI group

OMT DRUG

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

Also known as: optimal medical therapy

CTO-OMT group; CTO-PCI group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• (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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Leilei Chen

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Mei Wang

CONTACT

0086 15256095215; 1513267113@qq.com

Lei Jiang

CONTACT

0086 18705501372; 2771248705@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 7, 2024
• Study Start: September 17, 2023
• Primary Completion: September 17, 2024
• Study Completion: September 17, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

CN (1)