HanYang University Medical Center (HYUMC) Registry (HYUMC)

June 29, 2023 updated by: Young-Hyo Lim, Hanyang University Seoul Hospital

HanYang University Medical Center (HYUMC) PCI Registry

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

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

Study Locations

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

Consecutive patients with CAD

Description

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.

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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACCE (major adverse cardiac and cerebrovascular event)
Time Frame: 10-year
the composite of all-cause death, myocardial infarction, stroke, or any revascularization
10-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause death
Time Frame: 10-year
death from any cause
10-year
Myocardial infarction,
Time Frame: 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
10-year
Stroke
Time Frame: 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
10-year
Any revascularization
Time Frame: 10-year
PCI or coronary artery bypass surgery on either target or nontarget vessels
10-year

Collaborators and Investigators

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

Sponsor

Hanyang University Seoul Hospital

Collaborators

Hanyang 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)

January 1, 2012

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

June 29, 2023

First Submitted That Met QC Criteria

June 29, 2023

First Posted (Actual)

July 7, 2023

Study Record Updates

Last Update Posted (Actual)

July 7, 2023

Last Update Submitted That Met QC Criteria

June 29, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYUMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Drug and device information, study documents

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

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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