Clinical Trials Logo

Clinical Trial Summary

The majority of deaths after myocardial infarction occurs in patients with preserved left ventricular ejection fraction (>35%) for whom no prophylactic strategies exist. Periodic Repolarization Dynamics (PRD) and Deceleration Capacity (DC) of heart rate are autonomic risk markers that identify a new high risk group of patients with LVEF 35-50% who have the same poor prognosis as patients with LVEF ≤35%. In SMART-MI, post-infarction patients with LVEF 35-50% and abnormal PRD and/or DC will be randomly assigned to biomonitoring-guided therapy or conventional follow-up.


Clinical Trial Description

Sudden cardiac death (SCD) is the most common single cause of death in the industrialized world. Patients after myocardial infarction (MI) are at increased risk of SCD. Current guidelines recommend prophylactic ICD-implantation in post-MI patients with reduced left ventricular ejection fraction (LVEF ≤35%). However, the majority of arrhythmic deaths after MI occurs in patients with LVEF >35% in whom no specific prophylactic strategies exist, indicating an important unmet medical need. There is a large body of evidence that presence of cardiac autonomic dysfunction after MI is associated with an increased susceptibility to malignant brady- and tachyarrhythmias eventually culminating in SCD. Periodic repolarization dynamics (PRD) and heart rate deceleration capacity (DC) are clinically validated autonomic risk markers that provide strong and independent prognostic information in post-MI patients with LVEF >35%. PRD and DC reflect different facets of autonomic function and can therefore be used in combination to predict risk. Previous studies demonstrated that combined assessment of PRD and DC identifies a new high-risk group among post-MI patients with moderately reduced LVEF (36-50%). This new high-risk group has similar characteristics with respect to prognosis and patient numbers as the established high-risk group identified by LVEF ≤35%. However, the exact mechanisms leading to death in this new high-risk group need to be investigated in order to develop specific preventive strategies. As known from studies with implantable cardiac monitors (ICM) in post-MI patients with LVEF ≤40% eventual death is often preceded by primarily asymptomatic serious arrhythmic events. These data suggest a potential time frame for pre-emptive interventions in case of arrhythmic events, which could improve outcome. Therefore, SMART-MI will assess the occurrence and prognostic implications of serious arrhythmic events in this newly identified high-risk group by remote monitoring with ICM. Survivors of acute MI (<40 days) and LVEF 36-50% undergo autonomic testing for presence of abnormal PRD and/or DC. Those with autonomic dysfunction will be randomly assigned to ICM-implantation or conventional follow-up. Superiority of ICMs in detection of predefined serious arrhythmic events will be tested based on a time-to-event analysis. A central ICM core lab will be implemented allowing for a response to arrhythmias within 48h. The effect of remote monitoring on clinical outcomes will be tested as secondary endpoints. The study will provide the rationale for a future guideline-relevant study testing prophylactic therapies in this newly identified high-risk group. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02594488
Study type Interventional
Source LMU Klinikum
Contact
Status Completed
Phase N/A
Start date May 6, 2016
Completion date February 2021

See also
  Status Clinical Trial Phase
Recruiting NCT06013813 - Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI N/A
Completed NCT04507529 - Peer-mentor Support for Older Vulnerable Myocardial Infarction Patients N/A
Recruiting NCT06066970 - Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery
Recruiting NCT03620266 - Effects of Bilberry and Oat Intake After Type 2 Diabetes and/or MI N/A
Completed NCT04097912 - Study to Gather Information to What Extent Patients Follow the Treatment Regimen of Low-dose Aspirin for Primary and Secondary Prevention of Diseases of the Heart and Blood Vessels
Completed NCT04153006 - Comparison of Fingerstick Versus Venous Sample for Troponin I.
Completed NCT03668587 - Feasibility and Security of a Rapid Rule-out and rule-in Troponin Protocol in the Management of NSTEMI in an Emergency Departement
Recruiting NCT01218776 - International Survey of Acute Coronary Syndromes in Transitional Countries
Completed NCT03076801 - Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease? N/A
Recruiting NCT05371470 - Voice Analysis Technology to Detect and Manage Depression and Anxiety in Cardiac Rehabilitation N/A
Recruiting NCT04562272 - Attenuation of Post-infarct LV Remodeling by Mechanical Unloading Using Impella-CP N/A
Completed NCT04584645 - A Digital Flu Intervention for People With Cardiovascular Conditions N/A
Active, not recruiting NCT04475380 - Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
Not yet recruiting NCT06007950 - Time-restricted Eating Study (TRES): Impacts on Anthropometric, Cardiometabolic and Cardiovascular Health N/A
Withdrawn NCT05327855 - Efficacy and Safety of OPL-0301 Compared to Placebo in Adults With Post-Myocardial Infarction (MI) Phase 2
Recruiting NCT02876952 - High Intensity Aerobic Interval Training With Mediterranean Diet Recommendations in Post-Myocardial Infarct Patients N/A
Completed NCT02711631 - Feasibility and Effectiveness of Remote Virtual Reality-Based Cardiac Rehabilitation N/A
Completed NCT02917213 - Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction
Completed NCT02382731 - Interventions to Support Long-Term Adherence aNd Decrease Cardiovascular Events Post-Myocardial Infarction N/A
Completed NCT02305602 - A Study of VentriGel in Post-MI Patients Phase 1