NCT06071741

Brief Summary

  • This is a hospital-based registry study that will be to describe clinical and paraclinical features, procedural-related characteristics, short and long-term outcomes, hospital costs of patients undergoing percutaneous coronary intervention (PCI) at University Medical Center of Ho Chi Minh City (UMC), together with investigating predictors for patients' adverse clinical outcomes.
  • The specific objectives of this study are:
  • To validate a framework/model of PCI registry in UMC
  • To investigate the demographic, clinical of cardiovascular diseases and procedural characteristics of patient undergoing PCI in UMC
  • To investigate the procedural success, in-hospital adverse events and patient outcomes at one-month, three-month, twelve-month, three-year and five-year follow-up after PCI in UMC
  • To estimate in-hospital and procedural costs associated with PCI in UMC
  • To develop a prognostic prediction model for patients after PCI in UMC

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,600

participants targeted

Target at P75+ for all trials

Timeline
58mo left

Started Mar 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Mar 2023Mar 2031

Study Start

First participant enrolled

March 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2031

Expected
Last Updated

May 22, 2024

Status Verified

May 1, 2024

Enrollment Period

3 years

First QC Date

October 1, 2023

Last Update Submit

May 20, 2024

Conditions

Coronary Artery Disease

Keywords

Percutaneous Coronary InterventionRegistryVietnamCoronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • MACE endpoint (Major adverse cardiovascular event)

    Composite endpoint (MACE: major adverse cardiovascular event): occurence of cardiovascular death, non-fatal or fatal myocardial infraction, non-fatal or fatal stroke, Target Lesion revascularisation or Target Vessel Revascularisation

    Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up

Secondary Outcomes (12)

  • Rate of Ischemia driven target lesion revascularization (ID-TLR)

    Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up

  • Rate of Target Lesion Revascularization (TLR)

    Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up

  • Rate of Target Vessel Revascularization (TVR)

    Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up

  • Rate of Ischemia driven target vessel revascularization (ID-TVR)

    Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up

  • Rate of Ischemia driven non target vessel revascularization (ID-NTVR)

    Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up

  • +7 more secondary outcomes

Study Arms (1)

PCI group

Patients undergoing Percutaneous Coronary Intervention

Procedure: Percutaneous Coronary Intervention

Interventions

Percutaneous Coronary InterventionPROCEDURE

balloon angioplasty, stent implantation, atherectomy, intravascular ultrasound.

PCI group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients performing any PCI procedure(s) in given timeframe will be included in this registry

You may qualify if:

  • All patients undergoing any PCI procedure(s) in given timeframe will be included in this registry

You may not qualify if:

  • No informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center

Ho Chi Minh City, 70000, Vietnam

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2023

First Posted

October 6, 2023

Study Start

March 1, 2023

Primary Completion

March 1, 2026

Study Completion (Estimated)

March 1, 2031

Last Updated

May 22, 2024

Record last verified: 2024-05

Locations

VN(1)