Risk Stratification in Patients With Preserved Ejection Fraction (PRESERVE-EF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of Athens
Sponsor:
Collaborators:
Medtronic
General Electric
Information provided by (Responsible Party):
Kostantinos A. Gatzoulis, University of Athens
ClinicalTrials.gov Identifier:
NCT02124018
First received: April 24, 2014
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

The purpose of the study is to assess the prevalence and the prognostic value of non-invasive indexes and programmed ventricular stimulation for sudden cardiac death in post-MI patients with LVEF >40%.


Condition Intervention
Myocardial Infarction
Procedure: Programmed ventricular stimulation
Device: ICD implantation

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Post Myocardial Infarction Risk Stratification for Sudden Cardiac Death in Patients With Preserved Ejection Fraction: PRESERVE-EF

Resource links provided by NLM:


Further study details as provided by University of Athens:

Primary Outcome Measures:
  • Sudden cardiac death, sustained VT, appropriate ICD activation [ Time Frame: From enrollment till 3 years of follow-up ] [ Designated as safety issue: No ]
    Prevalence and prognostic value (positive and negative) of non-invasive and invasive indexes for SCD and appropriate ICD activation


Secondary Outcome Measures:
  • Non-invasive indexes variability [ Time Frame: 1 year after enrollment ] [ Designated as safety issue: No ]
    Repeat non-invasive indexes in fresh STEMI (first control in 40 days post-MI) 1 year later


Other Outcome Measures:
  • Predictors of VT inducibility [ Time Frame: Baseline evaluation ] [ Designated as safety issue: No ]
    Correlation of non-invasive indexes (SAECG, Holter monitoring) with VT induction in PVS


Estimated Enrollment: 1000
Study Start Date: April 2014
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Post-MI patients

Asymptomatic post-MI patients late after MI or 40 days after STEMI-NSTEMI with preserved ejection fraction and absence of active ischemia Programmed ventricular stimulation will be performed in high-risk patients based on non-invasive evaluation.

ICD implantation will be performed in patients with induced VT in programmed ventricular stimulation

Procedure: Programmed ventricular stimulation
Programmed ventricular stimulation in high-risk patients based on non-invasive evaluation
Device: ICD implantation
ICD implantation in patients with induced VT in programmed ventricular stimulation

Detailed Description:

1000 asymptomatic post-MI patients>40%, at least 40 days till 3 years post-MI, revascularized or without needing further revascularization (in any case without any evidence of ischemia) will be enrolled.

The patients will be divided into two categories:

  1. Asymptomatic patients with revascularized STEMI (remaining stenoses in non culprit vessels <70%) at 40 days post-MI (when LVEF>40% will be re-assessed)
  2. Asymptomatic patients late (till 3 years) after MI (initially STEMI-NSTEMI at discharge Q-non Q) with LVEF>40% right after a negative stress test or right after a negative for stenoses control coronary catheterization All patients will undergo non-invasive evaluation (ECG, Holter monitoring and 45-min high resolution recording). In case they fulfill at least one out of seven pre-specified criteria they will undergo programmed ventricular stimulation and ICD implantation (if inducible) All patients will be followed-up for 3 years for sudden cardiac death and its surrogate (appropriate ICD activation)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

1000 asymptomatic post-MI patients>40%, at least 40 days post-MI, revascularized or without needing further revascularization (in any case without any evidence of ischemia)

The patients will be divided into two categories:

  1. Asymptomatic patients with revascularized STEMI (remaining stenoses in non culprit vessels <70%) at 40 days post-MI (when LVEF>40% will be re-assessed)
  2. Asymptomatic patients late after MI (initially STEMI-NSTEMI at discharge Q-non Q) with LVEF>40% right after a negative stress test or right after a negative for stenoses control coronary catheterization
Criteria

Inclusion Criteria:

  • Asymptomatic patients with revascularized STEMI (remaining stenoses in non culprit vessels <70%) at 40 days post-MI (when LVEF>40% will be re-assessed)
  • Asymptomatic patients late after MI (initially STEMI-NSTEMI at discharge Q-non Q) with LVEF>40% right after a negative stress test or right after a negative for stenoses control coronary catheterization

Exclusion Criteria:

  • Episodes of sustained VT or aborted SCD 48 hours after the acute MI phase.
  • Episodes of syncope within the last 6 months
  • Cancer, liver failure (cirrhosis), end-stage renal disease
  • Use of anti-arrhythmic drugs other than b-blockers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02124018

Contacts
Contact: Konstantinos Gatzoulis, MD, PhD kgatzoul@med.uoa.gr
Contact: Dimitris Tsiachris, MD, PhD +306944849926 dtsiachris@yahoo.com

Locations
Greece
First Cardiology Clinic, Hippokration Hospital Recruiting
Athens, Greece, 11527
Contact: Konstantinos Gatzoulis, MD, PhD       kgatzoul@med.uoa.gr   
Contact: Dimitris Tsiachris, MD, PhD       dtsiachris@yahoo.com   
Sub-Investigator: Dimitris Tsiachris, MD, PhD         
Sponsors and Collaborators
University of Athens
Medtronic
General Electric
Investigators
Principal Investigator: Konstantinos Gatzoulis, MD, PhD University of Athens, Hippokration Hospital
  More Information

No publications provided

Responsible Party: Kostantinos A. Gatzoulis, Assoc. Professor of Cardiology, University of Athens
ClinicalTrials.gov Identifier: NCT02124018     History of Changes
Other Study ID Numbers: UOA-PRESERVE1
Study First Received: April 24, 2014
Last Updated: September 8, 2014
Health Authority: Greece: Ethics Committee

Keywords provided by University of Athens:
Myocardial infarction
Risk stratification
Sudden cardiac death
Preserved ejection fraction
Programmed ventricular stimulation

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Death, Sudden, Cardiac
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Heart Arrest
Death, Sudden
Death

ClinicalTrials.gov processed this record on September 22, 2014