Coronary Artery DiseaseUMC-PCINCT06071741

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

An observational study of Coronary Artery Disease, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease
What is being tested?: Percutaneous Coronary Intervention
Type of treatment: Surgery or procedure
How many people: 3,600 participants
Where: 1 siteVietnam
Study dates: 1 Mar 2023to 1 Mar 2031
How long will I take part?: 5 Years
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

No informed consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Vietnam1 site, 1 recruiting

University Medical Center
Ho Chi Minh City, 70000
Vu H Vu, Master, +84 908431304, vu.vh@umc.edu.vn
Bao T Duong, Master, +84 936287137, bao.dt1@umc.edu.vn
Recruiting

Other trials in Vietnam

About this study

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

Read the detailed description

The central single-center registry study will be conducted and monitored over a period of 5 years on patients who have undergone percutaneous coronary intervention (PCI) at UMC. The UMC-PCI registry study will utilize the ACS-PCI variables that have been standardized by EUROHEART.
This study will help to understand the practice of PCI in one of the biggest PCI centers in Southern Vietnam, as it assesses the characteristics, treatments and outcomes of CVD patients who receive PCI procedures, as well as information regarding PCI cost. The collection tools capture the data that measures adherence to validated EUROHEART's data set about ACS-PCI.
Through the capture and reporting of trusted and reliable data, UMC-PCI Registry helps participants measure and benchmark in specific aims:
To examine patient baseline characteristics by demographics, medical history, clinical manifestations before PCI
To obtain information of revascularization procedure with: coronary balloon, drug-eluting balloon, bare-metal stent, drug-eluting stent, bioresorbable vascular scaffold, rotational atherectomy device, directional coronary atherectomy device, thrombus aspiration, distal protection, the use of mechanical circulatory support devices, procedural success/failure and access site
To estimate successful rate in procedure performance and clinical appearance
To investigate peri-procedure and in-hospital complications
To obtain results of cardiac enzymes and other biomarkers after procedure
To examine discharge medication and follow-up plan
To obtain: MACE (Major Adverse Cardiac Event), patient symptoms, wellbeing, medications and laboratory results at the one-month, three-month, twelve-month, three-year and five-year follow-up. The trial will be conducted in the University Medical Center at Ho Chi Minh City. The Interventional Cardiology department at Ho Chi Minh City is the setting to recruit patients requiring PCI in Ho Chi Minh City as well as neighboring provinces. Approximately 1200 cases are performed annually in this department. This is a relatively large number and has the potential to conduct meaningful studies regarding this field.
All patients with coronary artery diseases with PCI agreeing to participate will be included. Patients' data will be collected and managed through REDCap. These data include information of patients' demographics, clinical history and presentations, treatments, and blood test results. The data collection forms are based on EUROHEART's data set.
After PCI, data related to the procedure are collected including indications for performing the procedure, coronary angiogram result, degree of stenosis, coronary blood flow grade, thrombus burden, type, number and total length of stent(s) used, the usage of advance techniques during the procedure (e.g., use of intravascular ultrasound, measures of fractional flow reserve, and use of rotational atherectomy). These data will detail how PCI is performed, both in terms of technical aspects and patient outcomes.
In-hospital complications, discharge medications, intervention costs, such as angiography procedure costs, balloon and stent expense, and additional supporting devices charges..., as well as overall in-hospital costs will be gathered. These will help monitoring procedure's complications, identifying factors influencing the occurrence of these events, optimization of post-procedural medications and giving an overall view of the economic burden faced by the patient and the healthcare system.
All patients will be contacted by phone after one-month, three-month, twelve-month, three-year and five-year following the PCI procedure. The investigators will collect information on patients' status and incident data on MACE, bleeding complication, medications and impact of angina on quality of life using SAQ-7.
The data will be entered into the REDCap program, which will subsequently be processed with the R 4.1.0 program. With a p value < 0.05 and a 95 percent confidence interval, all of the analyses are statistically significant. The investigators employ descriptive statistics, one-variable statistics, and statistics with multiple variables. Qualitative data will be presented as rates and percentages using descriptive statistics, the data will then be processed using the Chi-square test. The investigators report quantitative data as mean (standard deviation) for normal distributions and median (interquartile range) for other distributions. The investigators will use an unpaired t-test to compare means.

Conditions: Coronary Artery Disease
Being tested: Percutaneous Coronary Intervention
Keywords: Percutaneous Coronary Intervention, Registry, Vietnam, Coronary Artery Disease
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Percutaneous Coronary InterventionProcedure or surgery
balloon angioplasty, stent implantation, atherectomy, intravascular ultrasound.

Study groups in NCT06071741
Study group	Role	What they receive
PCI group		Patients undergoing Percutaneous Coronary Intervention Receives: Procedure: Percutaneous Coronary Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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)
Ischemia driven target lesion revascularization (ID-TLR)
Measured: 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)
All Target Lesion Revascularization
Measured: 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)
All Target Vessel Revascularization
Measured: 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)
Ischemia driven target vessel revascularization (ID-TVR)
Measured: 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)
Ischemia driven non target vessel revascularization (ID-NTVR)
Measured: Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up
Rate of All revascularization
All revascularization
Measured: Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up
Rate of Death
Cardiovascular Death, All-Cause Death
Measured: Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up
Composite: Cardiovascular death or myocardial infarction
Composite: Cardiovascular death or myocardial infarction
Measured: Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up
Composite: All-cause death or myocardial infarction
Composite: All-cause death or myocardial infarction
Measured: Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up
Composite: All-cause death, myocardial infarction or target vessel revascularization
Composite: All-cause death, myocardial infarction or target vessel revascularization
Measured: Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up
Anginal Status
Anginal Status by Seattle Angina Questionnaire-7 (SAQ-7)
Measured: Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up
Rate of Stent Thrombosis
Composite: Probable or definite stent thrombosis Probable Stent Thrombosis Definite Stent Thrombosis
Measured: Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20231 Mar 2031

First posted6 Oct 2023
Study start1 Mar 2023
Primary completion1 Mar 2026 (estimated)
Study completion1 Mar 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 3,600 participants (estimated)
Target duration: 5 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT06071741
Sponsor's protocol ID: 257/2023/HD-DHYD
Acronym: UMC-PCI
Status last verified: May 2024
First submitted: 1 Oct 2023
Last updated: 22 May 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Hoang Vu V, Nguyen KD, Duong BT, Pham NM, Reid CM, Truong BQ, Norman R. An Euroheart-Based Percutaneous Coronary Intervention Registry in Vietnam: Design, Rationale, and Preliminary Results. Catheter Cardiovasc Interv. 2025 Aug;106(2):1425-1432. doi: 10.1002/ccd.31700. Epub 2025 Jun 19.
PubMed 40536053

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Percutaneous Coronary Intervention Registry in University Medical Center of Ho Chi Minh City
ClinicalTrials.gov ID: NCT06071741
Acronym / sponsor ID: UMC-PCI / 257/2023/HD-DHYD
Conditions: Coronary Artery Disease
Keywords: Percutaneous Coronary Intervention, Registry, Vietnam, Coronary Artery Disease
Study type: Observational
Recruitment status: Recruiting
Enrolment: 3,600 participants (estimated)
Lead sponsor: University Medical Center Ho Chi Minh City (UMC)University, hospital or other
Study start: 1 Mar 2023 (actual)
Primary completion: 1 Mar 2026 (estimated)
Study completion: 1 Mar 2031 (estimated)
First posted: 6 Oct 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

The central single-center registry study will be conducted and monitored over a period of 5 years on patients who have undergone percutaneous coronary intervention (PCI) at UMC. The UMC-PCI registry study will utilize the ACS-PCI variables that have been standardized by EUROHEART.
This study will help to understand the practice of PCI in one of the biggest PCI centers in Southern Vietnam, as it assesses the characteristics, treatments and outcomes of CVD patients who receive PCI procedures, as well as information regarding PCI cost. The collection tools capture the data that measures adherence to validated EUROHEART's data set about ACS-PCI.
Through the capture and reporting of trusted and reliable data, UMC-PCI Registry helps participants measure and benchmark in specific aims:
To examine patient baseline characteristics by demographics, medical history, clinical manifestations before PCI
To obtain information of revascularization procedure with: coronary balloon, drug-eluting balloon, bare-metal stent, drug-eluting stent, bioresorbable vascular scaffold, rotational atherectomy device, directional coronary atherectomy device, thrombus aspiration, distal protection, the use of mechanical circulatory support devices, procedural success/failure and access site
To estimate successful rate in procedure performance and clinical appearance
To investigate peri-procedure and in-hospital complications
To obtain results of cardiac enzymes and other biomarkers after procedure
To examine discharge medication and follow-up plan
To obtain: MACE (Major Adverse Cardiac Event), patient symptoms, wellbeing, medications and laboratory results at the one-month, three-month, twelve-month, three-year and five-year follow-up. The trial will be conducted in the University Medical Center at Ho Chi Minh City. The Interventional Cardiology department at Ho Chi Minh City is the setting to recruit patients requiring PCI in Ho Chi Minh City as well as neighboring provinces. Approximately 1200 cases are performed annually in this department. This is a relatively large number and has the potential to conduct meaningful studies regarding this field.
All patients with coronary artery diseases with PCI agreeing to participate will be included. Patients' data will be collected and managed through REDCap. These data include information of patients' demographics, clinical history and presentations, treatments, and blood test results. The data collection forms are based on EUROHEART's data set.
After PCI, data related to the procedure are collected including indications for performing the procedure, coronary angiogram result, degree of stenosis, coronary blood flow grade, thrombus burden, type, number and total length of stent(s) used, the usage of advance techniques during the procedure (e.g., use of intravascular ultrasound, measures of fractional flow reserve, and use of rotational atherectomy). These data will detail how PCI is performed, both in terms of technical aspects and patient outcomes.
In-hospital complications, discharge medications, intervention costs, such as angiography procedure costs, balloon and stent expense, and additional supporting devices charges..., as well as overall in-hospital costs will be gathered. These will help monitoring procedure's complications, identifying factors influencing the occurrence of these events, optimization of post-procedural medications and giving an overall view of the economic burden faced by the patient and the healthcare system.
All patients will be contacted by phone after one-month, three-month, twelve-month, three-year and five-year following the PCI procedure. The investigators will collect information on patients' status and incident data on MACE, bleeding complication, medications and impact of angina on quality of life using SAQ-7.
The data will be entered into the REDCap program, which will subsequently be processed with the R 4.1.0 program. With a p value < 0.05 and a 95 percent confidence interval, all of the analyses are statistically significant. The investigators employ descriptive statistics, one-variable statistics, and statistics with multiple variables. Qualitative data will be presented as rates and percentages using descriptive statistics, the data will then be processed using the Chi-square test. The investigators report quantitative data as mean (standard deviation) for normal distributions and median (interquartile range) for other distributions. The investigators will use an unpaired t-test to compare means.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 5 Years
Number of arms: 1

Arm	Type	Receives
PCI group	–	Procedure: Percutaneous Coronary InterventionPatients undergoing Percutaneous Coronary Intervention

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All patients performing any PCI procedure(s) in given timeframe will be included in this registry

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

No informed consent

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Percutaneous Coronary Interventionballoon angioplasty, stent implantation, atherectomy, intravascular ultrasound.	Procedure or surgery	PCI group

Primary outcome

MACE endpoint (Major adverse cardiovascular event)
Time frame: Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up
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

12 secondary outcomes

Rate of 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
Rate of Target Lesion Revascularization (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
Rate of Target Vessel Revascularization (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
Rate of 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
Rate of Ischemia driven non target vessel revascularization (ID-NTVR)
Time frame: Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up
Rate of All 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
Rate of Death
Time frame: Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up
Composite: Cardiovascular death or myocardial infarction
Time frame: Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up
Composite: All-cause death or myocardial infarction
Time frame: Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up
Composite: All-cause death, myocardial infarction or 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
Anginal Status
Time frame: Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up
Rate of Stent Thrombosis
Time frame: Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
Derived from this study: PubMed 40536053Hoang Vu V, Nguyen KD, Duong BT, Pham NM, Reid CM, Truong BQ, Norman R. An Euroheart-Based Percutaneous Coronary Intervention Registry in Vietnam: Design, Rationale, and Preliminary Results. Catheter Cardiovasc Interv. 2025 Aug;106(2):1425-1432. doi: 10.1002/ccd.31700. Epub 2025 Jun 19.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

University Medical Center

Ho Chi Minh City, Vietnam

+84 908431304

vu.vh@umc.edu.vn

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MACE endpoint (Major adverse cardiovascular event) (time frame: Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06071741, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.