Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03263949 |
| Other study ID # |
1533/17 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 9, 2017 |
| Est. completion date |
February 1, 2023 |
Study information
| Verified date |
February 2023 |
| Source |
Clinical Centre of Serbia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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.
