An observational study in Risk Stratification, sponsored by Clinical Centre of Serbia. Completed at 1 site in Serbia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-10.
Sponsored by Clinical Centre of Serbia · Observational
Predict-VT is an investigator-initiated, prospective, observational clinical trial. Four hundred patients with ST elevation acute myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI) will be included. The primary end point is a composite of ventricular tachyarrhythmia (VTA) and sudden cardiac death (SCD). VTAs will be recorded using continuous electrocardiographic (ECG) monitoring in the coronary unit for the first 72 hours, standard ECG and ECG holter monitoring. For the analysis of myocardial function, conventional 2D echocardiography and tissue doppler will be used. For the evaluation of myocardial mechanics, 2D speckle tracking, strain, strain rate and mechanical dispersion will be obtained. Important clinical, laboratory and angiographic variables will also be examined. Patients will be followed-up at 40 days and 1 year. The optimal VTA prediction model will be constructed using logistic regression and bootstrap models. Patients who experience primary end point should undergo secondary SCD prevention using implantable cardioverter defibrillator (ICD). Patients with left ventricular ejection fraction (LVEF) \< 35%, 40 days post acute myocardial infarction (AMI), will be candidates for primary SCD prevention.
Study design Predict-VT is an investigator-initiated, prospective, open-label, single-center clinical trial. The research protocol has been approved by the Ethics Committee of the Clinical Center of Serbia. All participants will have to provide their informed consent in writing. The trial design will ensure that all participants abide by good clinical practice and the ethical principles of the Declaration of Helsinki II.
Study population The study will include at least 400 patients with acute myocardial infarction with ST elevation (STEMI) who are elgible for treatment with primary percutaneous coronary intervention (PPCI) within 12 hours from the onset of symptoms. Enrollment started on January 2017 . Recruitment will continue until 400 patients have been randomized. The end of the recruitment period is planned for January 2021. The trial will continue until all available survivors have been followed for at least 1 year.
Objectives, end points and definitions The primary objective of PREDICT-VT trial is to test the hypothesis that the occurrence of ventricular tachyarrhythmias (VTA) and sudden cardiac death (SCD) is predictable with acceptable accuracy among STEMI patients undergoing PPCI. Therefore, the PREDICT-VT specified primary end point is the analysis of independent predictors of VTA and SCD in a period of 3-40 days following STEMI. The second objective of the study is the stratification of risk for VTA by constructing optimal predictive models and defining the classes of risk. The third objective of the study is a validation of the model using an independent sample of patients. The study's subanalyses will include: a. Analysis of the significance of non-sustained VTA lasting \<30 seconds for the prognosis of patients with STEMI, b. Importance of frequent ventricular premature beats and/or emerging atrial fibrillation for the prognosis of patients and the emergence of SCD, c. Definition of risk factors for the occurrence of VTA in the subgroup of patients with preserved left ventricular ejection fraction (LVEF), considering that more than half of the SCD victims have preserved LVEF.
Noninvasive and invasive assessment A 24-hour ECG Holter monitoring will be performed in the period of 5 ± 2 days after STEMI.
Echocardiographic examination on Vivid E9 (General Electric) echocardiographic device will be performed 5 ± 2 days after STEMI and repeated after 50 ± 10 days. Standard echocardiographic methods of M-mode, 2D, color, pulse, continuous doppler, tissue doppler and 2D speckle tracking will be used. The analysis will include the parameters of systolic and diastolic functions and myocardial mechanics in accordance with the latest recommendations of the European / American Echocardiographic Association.
The following angiographic variables will be analyzed: significant coronary artery stenosis -localization and number, number of diseased coronary vessels, length of stenosis, type of stenosis, coronary flow before and after the intervention, type and number of implanted stents.
Patients will be followed-up after discharge from hospital for the occurrence of specified end points at 40 days and 1 year after enrollment by scheduled telephone interviews and outpatient visits. An independent Clinical Event Committee, composed of 3 cardiologists will review and adjudicate the occurrence of each suspected clinical end point.
2,270 studies on the registry are indexed under Myocardial Infarction; 371 are open to participants now.
This study's enrollment of 400 is below the median of 568 across 814 observational studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Clinical Centre of Serbia is the lead sponsor of 24 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study will include 600 patients with acute myocardial infarction (AMI) with ST elevation (STEMI) who are eligible for treatment with primary percutaneous coronary intervention (PPCI) within 12 hours from the onset of symptoms.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
For the analysis of myocardial function, conventional 2D echocardiography and tissue doppler will be used. For the evaluation of myocardial mechanics, 2D speckle tracking, strain, strain rate and mechanical dispersion will be obtained.
Composite of ventricular tachyarrhythmias and sudden cardiac death
Analysis of independent predictors of ventricular tachyarrhythmias and sudden cardiac death in a period of 3-40 days following STEMI. Predictors will be identified from clinical, laboratory, echocardiographic, angiographic and procedural variables collected in the study database, using statistical methods of univariable logistic regression and Cox proportional hazard model. Statistical methods of multivariable logistic regression, bootstrapping and receiver operating characteristic curve analysis will be used for the identification of independent predictors of outcome.
Time frame: 3-40 days after STEMI
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2017 to primary completion in Oct 2022, 69 months.
Of 296 non-industry observational studies under Myocardial Infarction, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 140. This study's 69 months is above that.
Counting every sponsor, half of 333 studies reached it within 48 months; a quarter within 17 and three quarters within 114.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Clinical Centre of Serbia