Risk Stratification in Patients With Preserved Ejection Fraction

NCT02124018 | Completed Results DMC

• 1 other identifier: UOA-PRESERVE1
• Study Type: observational
• Target: 575
• Locations: 1 country
• Sites: 1

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-myocardial infarction (MI) patients with left ventricular ejection fraction (LVEF)\>40%.

Conditions

Myocardial Infarction

Keywords

Myocardial infarction; Risk stratification; Sudden cardiac death; Preserved ejection fraction; Programmed ventricular stimulation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Major Arrhythmic Events (MAEs) - Present When One of the Following Occurred: Sudden Cardiac Death, Sustained Ventricular Tachycardia, or Implantable Cardioverter - Defibrillator (ICD) Activation

  The number of patients from each risk level group meeting the primary endpoint will be used to assess diagnostic accuracy (positive/negative predictive value, sensitivity and specificity) of the proposed two-stage, PVS-inclusive, risk stratification approach for the allocation of an ICD

  From stratification completion (i.e. allocation to one of three risk level groups) until either occurrence of primary endpoint or study completion (mean 32months) - study stopped early due to emergence of clearly defined high risk subgroup

Secondary Outcomes (1)

• Total Mortality

  From completion of risk stratification to study completion or outcome occurrence (mean 32 months)

Study Arms (1)

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 (PVS) will be performed in high-risk patients based on non-invasive evaluation. ICD implantation will be performed in patients with induced ventricular tachycardia (VT) upon PVS

Procedure: Programmed ventricular stimulation; Device: ICD implantation

Interventions

Programmed ventricular stimulation PROCEDURE

Programmed ventricular stimulation in high-risk patients based on non-invasive evaluation

Post-MI patients

ICD implantation DEVICE

ICD implantation in patients with induced VT in programmed ventricular stimulation

Post-MI patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Episodes of sustained VT or aborted sudden cardiac death (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

Sponsors & Collaborators

• University of Athens: lead
• Medtronic: collaborator
• General Electric: collaborator

Study Sites (1)

First Cardiology Clinic, Hippokration Hospital

Athens, 11527, Greece

Location

Related Publications (1)

• 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 Sep 14;40(35):2940-2949. doi: 10.1093/eurheartj/ehz260.

  PMID: 31049557 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Study was not a randomized clinical trial since almost all patients with a per protocol indication received a device, without the presence of a high-risk control group, thus potentially overestimating true arrhythmic risk.

Results Point of Contact

• Title: Professor Konstantinos A. Gatzoulis
• Organization: First Department of Cardiology, School of Medicine, National and Kapodistrian University of Athens

kgatzoul@med.uoa.gr

6944580369

Study Officials

• Konstantinos Gatzoulis, MD, PhD

  University of Athens, Hippokration Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Professor of Cardiology

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 28, 2014
• Study Start: April 1, 2014
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: September 4, 2019
• Results First Posted: August 26, 2019

Record last verified: 2019-08

Locations

GR (1)