CClinicalTrials.gg
CompletedNCT00081666Updated Jul 29, 2016

Logical Analysis of Data and Cardiac Surgery Risk

An observational study in Cardiovascular Diseases, Heart Diseases and Coronary Disease, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Completed. Open to participants aged Up to 100 Years. Per ClinicalTrials.gov, last updated 2016-07-29.

Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Observational

Study type
Observational
Ages
Up to 100 Years
Sex
All
01

Study summary

To use a new statistical method, the Logical Analysis of Data (LAD), to predict cardiac surgery risk.

Read the detailed description

BACKGROUND:

One of the most important tasks that cardiovascular clinicians perform is risk stratification, as that enables appropriate targeting of aggressive treatments to patients that are most likely to benefit from them. Contemporary risk stratification strategies include clinical scoring systems along with performance of noninvasive tests. Although these approaches are commonly used, clinicians still find themselves needing to incorporate multiple pieces of clinical information into a cohesive global risk assessment. The concept of utilizing data from large observational data sets to develop complex risk scores and to encourage their use in routine practice is therefore gradually evolving and gaining acceptance. The Logical Analysis of Data (LAD) is a potentially useful approach for systematically analyzing large databases for the purpose of developing and validating clinically useful risk prediction schemes. Unlike standard regression techniques, LAD does not primarily focus on individual risk factors and two-way interactions between them. Rather, LAD is designed to identify complex patterns of findings, or syndromes, that predict outcomes. This method has been applied to problems in economics, seismology and oil exploration, but not to medicine.

DESIGN NARRATIVE:

The study has three specific aims: 1). to apply LAD to develop and validate risk prediction instruments among patients undergoing different types of cardiac surgery. 2. to compare the predictive value of LAD predictive instruments with predictive instruments developed using standard statistical methods, including multiple time-phase parametric modeling. 3. to develop predictive instruments using relative risk forests, a new Monte Carlo method for estimating risk values in large survival data settings with large numbers of correlated variables. Relative risk forests are an adaptation of random forests introduced by Breiman. When possible these methods will be compared to LAD. Internal estimates for the generalization error, a measure of how well the method will generalize to other data settings, will be computed and will be used in the development of the predictive instrument. Relative risk forests will also be compared to several other non-deterministic methods, including boosting and spike and slab variable selection. All of these techniques can be used to develop complex models while maintaining good prediction error and are ideal for high dimensional problems where traditional methods breakdown. Although this project will focus on risk assessment among patients undergoing cardiac surgery, it is important to recognize that we are primarily interested in the value of LAD as a means of analyzing very large and complex data sets within a medical sphere. Hence, the applicability of this work goes beyond determination of risk of patients undergoing cardiac surgery.

Data used for this study will consist of cardiac surgery data from the Cleveland Clinic Foundation Cardiovascular Information Registry (CVIR). Four cohorts of data will be assembled; Cohort I: 18,914 CABG patients between 1990 and 2000; Cohort II: 6952 patients undergoing aortic valve replacement; Cohort III: 2979 patients undergoing mitral valve replacement; Cohort IV: 10,482 patients undergoing mitral valve repair. The primary endpoint will be long term total mortality; for valve surgery patients it will be active follow-up.

02

Conditions studied

  • Cardiovascular Diseases
  • Heart Diseases
  • Coronary Disease
  • Aortic Valve Stenosis
  • Mitral Valve Stenosis
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

Browse Cardiovascular Diseases studies →

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,117 studies on the registry; 71 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 49 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

No eligibility criteria

05

Study design

06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00081666
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
First posted
Apr 21, 2004
Start date
Jul 2004
Primary completion
Jun 2007
Completion
Jun 2007
Last update
Jul 29, 2016

Study contacts

Michael Lauer
Clevland Clinic Lerner College of Medicine
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion