Predicting Ventricular Tachyarrhythmias Following Acute ST Elevation Myocardial Infarction

NCT03263949 | Completed

• 1 other identifier: 1533/17
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Risk Stratification

Keywords

risk prediction; ventricular arrhythmia; myocardial infarction

Outcome Measures

Primary Outcomes (1)

• 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.

  3-40 days after STEMI

Interventions

Diagnostic OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• years and older
• willing consent in writing
• undergoing primary PCI for STEMI

You may not qualify if:

• cardiogenic shock at admission,
• noncardiac conditions that could interfere with compliance with the protocol,
• coexisting conditions associated with a limited life expectancy in the follow-up period.
• Prior documented arrhythmias like atrial fibrillation or ventricular tachyarrhythmias,
• Permanent pacemaker implanted,
• Previous haemodynamically significant valvular abnormalities,
• Chest wall deformities disabling adequate echocardiographic examination.

Sponsors & Collaborators

• Clinical Centre of Serbia: lead

Study Sites (1)

Clinical Centre of Serbia, Emergency Hospital

Belgrade, 11000, Serbia

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Igor Mrdovic

  Clinical Centre of Serbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: August 28, 2017
• Study Start: January 9, 2017
• Primary Completion: October 14, 2022
• Study Completion: February 1, 2023
• Last Updated: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)