Clinical trial NCT06071741: The Percutaneous Coronary Intervention Registry in University Medical Center of Ho Chi Minh City
Official title: The Percutaneous Coronary Intervention Registry in University Medical Center of Ho Chi Minh City
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Keywords: Percutaneous Coronary Intervention
Registry
Vietnam
Coronary Artery Disease
Lead sponsor: University Medical Center Ho Chi Minh City (UMC)
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 3600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients performing any PCI procedure(s) in given timeframe will be included in this registry

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

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* No informed consent

Primary outcomes:
measure: MACE endpoint (Major adverse cardiovascular event)
timeFrame: Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up
Secondary outcomes:
measure: Rate of Ischemia driven target lesion revascularization (ID-TLR)
timeFrame: Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up
measure: Rate of Target Lesion Revascularization (TLR)
timeFrame: Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up
measure: Rate of Target Vessel Revascularization (TVR)
timeFrame: Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up
measure: Rate of Ischemia driven target vessel revascularization (ID-TVR)
timeFrame: Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up
measure: Rate of Ischemia driven non target vessel revascularization (ID-NTVR)
timeFrame: Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up
measure: Rate of All revascularization
timeFrame: Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up
measure: Rate of Death
timeFrame: Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up
measure: Composite: Cardiovascular death or myocardial infarction
timeFrame: Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up
measure: Composite: All-cause death or myocardial infarction
timeFrame: Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up
measure: Composite: All-cause death, myocardial infarction or target vessel revascularization
timeFrame: Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up
measure: Anginal Status
timeFrame: Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up
measure: Rate of Stent Thrombosis
timeFrame: Time-To-Event measure up to 5-year from baseline: 1-month, 3-month, 12-month, 3-year, 5-year follow-up
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: University Medical Center
Study officials:
References: