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The Percutaneous Coronary Intervention Registry in University Medical Center of Ho Chi Minh City

ConditionCoronary Artery Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Medical Center Ho Chi Minh City (UMC)

About this trial

* 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

No informed consent

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Percutaneous Coronary Intervention

    Procedure/Surgery

    balloon angioplasty, stent implantation, atherectomy, intravascular ultrasound.

Treatment groups

3,600 Participants
are divided into 1 treatment group
Group A: PCI group1 intervention

Trial outcomes

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

Secondary outcomes

1

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

Ischemia driven target lesion revascularization (ID-TLR)

Time frame
Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up
2

Rate of Target Lesion Revascularization (TLR)

All Target Lesion Revascularization

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

Rate of Target Vessel Revascularization (TVR)

All Target Vessel Revascularization

Time frame
Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up
4

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

Ischemia driven target vessel revascularization (ID-TVR)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Medical Center Ho Chi Minh City (UMC)

Lead sponsor

Source ClinicalTrials.gov
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