OAT:Defibrillator in Non-Ischemic Cardiomyopathy Treatment Evaluation Trial

The database (E-OTH-03-0802-018) hosts the Holter ECGs recorded during the OAT that was designed to determine whether opening an occluded infarcted artery (PCI) 3-28 days after an acute myocardial infarction in high-risk asymptomatic patients reduces the composite endpoint of mortality, recurrent myocardial infarction, and hospitalization for class IV congestive heart failure over a three year follow- up. The trial was conducted as a randomized study involving 2166 stable patients who had total occlusion of the infarct-related artery 3 to 28 days after myocardial infarction and who met a high-risk criterion (an ejection fraction of <50% or proximal occlusion).
Of these patients, 1082 were assigned to routine PCI and stenting with optimal medical therapy, and 1084 were assigned to optimal medical therapy alone. The trial demonstrated that PCI did not reduce the occurrence of death, reinfarction, or heart failure. Furthermore, there was a trend toward excess reinfarction during 4 years of follow-up in stable patients with occlusion of the infarct-related artery 3 to 28 days after myocardial infarction. Shared by New-York School of Medicine and SUNY, this new database includes 802 10-min ECG recordings from a subset of 223 patients enrolled in the OAT trial (3.6 Holter recordings per patient in average). The access to this database requires the user(s) to submit a short research proposal that will be reviewed by an ad-hoc committee consisting of the principal investigators of the OAT trial and its Holter-related substudy (i.e. Prof. Judith Hochman, MD from the NYU Langone Medical Center and Prof. Eric Rashba from Stony Brooke University of Medicine).

Study Design:

The Occluded Artery Trial (OAT) was a multicenter, international study that was designed to test the hypothesis that a strategy of late PCI to open the occluded IRA would reduce the first occurrence of a composite endpoint of death, reinfarction, or New York Heart Association (NYHA) IV heart failure by 25% compared with optimal medical treatment alone.

To be eligible, patients were required to have a confirmed MI with a completely occluded IRA (day 3-28), as well as high-risk criteria (ejection fraction < 50% and/or proximal occlusion of major epicardial vessel supplying > 25% of the left ventricle). Major exclusion criteria included left main or triple vessel disease, hemodynamic or electrical instability, rest or low-threshold angina, and NYHA class III-IV heart failure or shock.

Primary endpoint: Composite of death, rehospitalization for NYHA class IV heart failure or MI.

Secondary endpoints:

• The individual components of the primary endpoint;
  
  
• Clinical events; and
  
  
• Economic and quality-of-life endpoints.

ECG Number of Leads: 3 orthogonal lead configuration

ECG Sampling Frequency : 500 Hz and 1000Hz, provided in the ECG ISHNE file header for each patients

ECG Amplitude Resolution: provided in the ECG ISHNE file header for each patients

Clinical Information: This database includes many clinical factors and the study endpoints. A complete list of the recorded factors is provided in a pdf file (click here to download).

Publications based on the data:

1) Electrophysiological Effects of Late Percutaneous Coronary Intervention for Infarct-Related Coronary Artery Occlusion. The Occluded Artery Trial - Electrophysiological Mechanisms (OAT-EP). Eric J. Rashba, MD, Gervasio A. Lamas, MD, Jean-Philippe Couderc, PhD, Sharri M. Hollist, MPH, Vladimir Dzavik, MD, Witold Ruzyllo, MD, V. Fridrich, MD, Christopher E. Buller, MD, Sandra Forman, MA, Joseph A. Kufera, MA, Antonio C. Carvalho, MD, Judith S. Hochman, MD, and The OAT-EP Investigators. pubmed link