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Observational study on the management of high-risk patients for sudden cardiac death after coronary revascularization and the prognosis of S-ICD implantation

Observational study on the management of high-risk patients for sudden cardiac death after coronary revascularization and the prognosis of S-ICD implantation (EPCI-S study) - EPCI-S

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400084372
Enrollment
Unknown
Registered
2024-05-15
Start date
2024-05-20
Completion date
Unknown
Last updated
2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-PCI patients

Interventions

Survey queue: ICD group and non-ICD group:NA
S-ICD group:NA
TV-ICD group:NA

Sponsors

The First Affiliated Hospital of Xinjiang Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Retrospective EPCI Research Inclusion Criteria: 1. Participants must be at least 18 years old upon enrollment. 2. Have undergone PCI surgery within 1-3 years prior to the research initiation point (the date of ethical approval at the research center), have had cardiac ultrasound results within 3-12 months post-PCI procedure, and the ultrasound must indicate a Left Ventricular Ejection Fraction (LVEF) of =35%. Prospective EPCI Research Inclusion Criteria:Key selection criteria: 1. Participants must be at least 18 years old upon enrollment. 2. Undergo PCI surgery and, according to the consensus of EPCI experts, exhibit one of the following high-risk factors for sudden cardiac death or reevaluation evidence before discharge: a) Sustained Ventricular Tachycardia (SVT) or Ventricular Fibrillation (VF); b) Unexplained syncope; c) Cardiac ultrasound showing LVEF =35% (Simpson method); d) Cardiac ultrasound showing 35% 10 times/hour) or Non-Sustained Ventricular Tachycardia (NSVT). Capable of providing informed consent, willing to participate in the program for follow-up visits and relevant examinations, and willing to provide the necessary data.

Exclusion criteria

Exclusion criteria: Retrospective EPCI Research Main Exclusion Criteria: 1. Patients with ICD implanted before PCI surgery; 2. Non-ischemic etiology causing high-risk sudden cardiac death other than ischemia-related factors; 3. Undergoing repeat revascularization within 1 year post-PCI. Prospective EPCI Research Main Exclusion Criteria: 1. Patients with ICD implanted before PCI surgery; 2. Non-ischemic etiology causing high-risk sudden cardiac death other than ischemia-related factors; 3. Planned elective repeat revascularization within 1 year post-PCI; 4. Anticipated life expectancy of less than 1 year post-PCI according to the investigator's judgment; 5. Participation in or planning to participate in another study during the research period that may interfere with this study's conduct or results.

Design outcomes

Primary

MeasureTime frame
One-year implantable cardioverter-defibrillator (ICD) implantation rate after percutaneous coronary intervention (PCI);One-year all-cause mortality rate after percutaneous coronary intervention (PCI);Inappropriate Shock,IAS;Procedure and device-related adverse events;Device-related adverse events;

Secondary

MeasureTime frame
Rate of major cardiovascular adverse events occurring within 1 year after percutaneous coronary intervention (PCI);Rate of indication and proportion of various indications for implantable cardioverter-defibrillator (ICD) in patients with elective percutaneous coronary intervention (EPCI) within 1 year.;Rate of indication and proportion of various indications for implantable cardioverter-defibrillator (ICD) in patients with elective percutaneous coronary intervention (EPCI) within 1 year.;Rate of new requirement for anti-tachycardia pacing (ATP) or indication for anti-bradycardia pacing in patients with elective percutaneous coronary intervention (EPCI) who had S-ICD implanted within 2 years post-operation.;Screening pass rate of patients with elective percutaneous coronary intervention (EPCI) who choose to undergo S-ICD implantation.;

Countries

China

Contacts

Public ContactBaopeng Tang

The First Affiliated Hospital of Xinjiang Medical University

tangbaopeng1111@163.com+86 135 7988 1111

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026