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

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ClinicalTrials.gov Identifier: NCT02124018
Recruitment Status : Unknown
Verified December 2014 by Kostantinos A. Gatzoulis, University of Athens.
Recruitment status was:  Recruiting
First Posted : April 28, 2014
Last Update Posted : December 16, 2014
Sponsor:
Collaborators:
Medtronic
General Electric
Information provided by (Responsible Party):
Kostantinos A. Gatzoulis, University of Athens

Tracking Information
First Submitted Date April 24, 2014
First Posted Date April 28, 2014
Last Update Posted Date December 16, 2014
Study Start Date April 2014
Estimated Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 24, 2014)
Sudden cardiac death, sustained VT, appropriate ICD activation [ Time Frame: From enrollment till 3 years of follow-up ]
Prevalence and prognostic value (positive and negative) of non-invasive and invasive indexes for SCD and appropriate ICD activation
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02124018 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 24, 2014)
Non-invasive indexes variability [ Time Frame: 1 year after enrollment ]
Repeat non-invasive indexes in fresh STEMI (first control in 40 days post-MI) 1 year later
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 24, 2014)
Predictors of VT inducibility [ Time Frame: Baseline evaluation ]
Correlation of non-invasive indexes (SAECG, Holter monitoring) with VT induction in PVS
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Risk Stratification in Patients With Preserved Ejection Fraction
Official Title Post Myocardial Infarction Risk Stratification for Sudden Cardiac Death in Patients With Preserved Ejection Fraction: PRESERVE-EF
Brief Summary 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%.
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 (at any time after 40 days) 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)
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Years
Biospecimen Not Provided
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
Condition Myocardial Infarction
Intervention
  • 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
Study Groups/Cohorts 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

Interventions:
  • Procedure: Programmed ventricular stimulation
  • Device: ICD implantation
Publications * Gatzoulis KA, Tsiachris D, Arsenos P, Antoniou CK, Dilaveris P, Sideris S, Kanoupakis E, Simantirakis E, Korantzopoulos P, Goudevenos I, Flevari P, Iliodromitis E, Sideris A, Vassilikos V, Fragakis N, Trachanas K, Vernardos M, Konstantinou I, Tsimos K, Xenogiannis I, Vlachos K, Saplaouras A, Triantafyllou K, Kallikazaros I, Tousoulis D. Arrhythmic risk stratification in post-myocardial infarction patients with preserved ejection fraction: the PRESERVE EF study. Eur Heart J. 2019 May 3. pii: ehz260. doi: 10.1093/eurheartj/ehz260. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 24, 2014)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2019
Estimated Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Greece
Removed Location Countries  
 
Administrative Information
NCT Number NCT02124018
Other Study ID Numbers UOA-PRESERVE1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Kostantinos A. Gatzoulis, University of Athens
Study Sponsor University of Athens
Collaborators
  • Medtronic
  • General Electric
Investigators
Principal Investigator: Konstantinos Gatzoulis, MD, PhD University of Athens, Hippokration Hospital
PRS Account University of Athens
Verification Date December 2014