HanYang University Medical Center (HYUMC) Registry

Sponsor
Hanyang University Seoul Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05935397
Collaborator
Hanyang University (Other)
5,000
3
168
1666.7
9.9

Study Details

Study Description

Brief Summary

The HYUMC registry is a two-center, real-world registry of percutaneous coronary intervention in patients with coronary artery disease. From January 2012, PCI-treated patients from Hanyang University Seoul Hospitals and Hanyang University Guri Hospitals were enrolled in this registry.

The aim of this registry is to examine the long-term clinical outcomes and identify predictors of adverse outcomes following percutaneous coronary intervention conducted at academic hospitals.

Condition or Disease Intervention/Treatment Phase
  • Device: percutaneous coronary intervention

Detailed Description

In the HYUMC registry, the researchers have gathered and assessed various demographic, laboratory, echocardiographic, and angiographic measurements (both on-admission and during follow-up), as well as conducted questionnaires among patients who underwent percutaneous coronary intervention. The primary focus of this registry is to examine the effects of these parameters on long-term clinical outcomes.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
5000 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
HanYang University Medical Center (HYUMC) PCI Registry
Actual Study Start Date :
Jan 1, 2012
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
patients with CAD undergoing PCI

patients with CAD undergoing PCI with second generation DES

Device: percutaneous coronary intervention
patients with CAD undergoing PCI with second generation DES

Outcome Measures

Primary Outcome Measures

  1. MACCE (major adverse cardiac and cerebrovascular event) [10-year]

    the composite of all-cause death, myocardial infarction, stroke, or any revascularization

Secondary Outcome Measures

  1. All-cause death [10-year]

    death from any cause

  2. Myocardial infarction, [10-year]

    presence of clinical symptoms with the presence of electrocardiographic changes, or imaging evidence of new loss of viable myocardium or new regional wall motion abnormalities, in conjunction with elevated levels of cardiac biomarker above the 99th percentile upper reference limit

  3. Stroke [10-year]

    neurological deficit resulting from acute focal damage to the central nervous system due to a vascular cause, requiring hospitalization, and confirmed by a neurologist through imaging findings

  4. Any revascularization [10-year]

    PCI or coronary artery bypass surgery on either target or nontarget vessels

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Consecutive patients with CAD who underwent PCI one or more drug eluting stent (DES) with from 2012 at the Division of Cardiology of Hanyang University Seoul Hospital and Hanyang University Guri Hospital, Korea.

Exclusion Criteria:
  • second or subsequent hospitalization records of patients with multiple admissions

  • patients who died during index hospitalization

  • patients who treated with first-generation drug eluting stent

  • patients with an outpatient follow-up record of less than 6 months

  • patients with insufficient medical records.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hanyang University Guri Hospital Guri Korea, Republic of 11923
2 Hanyang University Seoul Hospital Seoul Korea, Republic of 04763
3 Young-Hyo Lim Seoul Korea, Republic of 04763

Sponsors and Collaborators

  • Hanyang University Seoul Hospital
  • Hanyang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Young-Hyo Lim, Prof., Hanyang University Seoul Hospital
ClinicalTrials.gov Identifier:
NCT05935397
Other Study ID Numbers:
  • HYUMC
First Posted:
Jul 7, 2023
Last Update Posted:
Jul 7, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2023