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NCT01114269 · ClinicalTrials.gov registry record

PRE-DETERMINE Cohort Study

A clinical trial of Coronary Artery Disease and Sudden Cardiac Death, sponsored by Brigham and Women's Hospital.

Active
Registry status
5,764
Enrollment target
20
Study locations

NCT01114269 is a study of Coronary Artery Disease and Sudden Cardiac Death that is active but no longer recruiting, run by Brigham and Women's Hospital. The registered enrollment target is 5,764 participants, above the 1,261-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (357% higher). The trial reports 20 study locations across 7 states.

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The verdict

NCT01114269, a study of Coronary Artery Disease and Sudden Cardiac Death, is active but no longer recruiting, sponsored by Brigham and Women's Hospital.

ACTIVE NOT RECRUITING
Registry status
5,764 participants
Enrollment target
20
Study locations

Study Summary

This is a prospective, multi-center cohort study of patients with a history of coronary artery disease (CAD) and documentation of either a prior myocardial infarction (MI) or mild to moderate left ventricular dysfunction (LVEF 35-50%). The primary objective of this study is to determine whether biologic markers and ECGs can be utilized to advance SCD risk prediction in patients with CHD and LVEF\>30-35%. The overarching goal of the study is to identify a series of markers that alone or in combination specifically predict risk of arrhythmic death as compared to other causes of mortality among this at risk population of coronary heart disease (CHD) patients with preserved left ventricular ejection fraction (LVEF\> 30-35%). If biologic or ECG markers are identified that can specifically predict risk of ventricular arrhythmias, then these markers may serve as relatively inexpensive methods to identify those at risk. The public health impact of identifying markers could be quite substantial, leading to more efficient utilization of ICDs and advances in our understanding of mechanisms underlying SCD.

Conditions Studied

Coronary Artery Disease Sudden Cardiac Death Left Ventricular Dysfunction

Study Locations (20)

Florida

  • Bay Area Cardiology Associates, P.A. - Brandon
  • University of Florida - Gainsville - Gainesville
  • Reliable Clinical Research - Miami
  • Mount Sinai Medical Center - Miami Beach
  • Florida Hospital - Orlando
  • Orlando Regional Medical Center - Orlando
  • Palm Beach Gardens Research Center - Palm Beach Gardens
  • Velella Research - Sarasota
  • Tallahassee Research Institute, Inc. - Tallahassee
  • Cardiology Associates of Palm Beach - West Palm Beach - West Palm Beach

Arizona

  • Phoenix Heart, PLLC - Glendale
  • Cardiovascular Consultants - Phoenix

Colorado

  • Memorial Health System - Colorado Springs
  • Colorado Heart and Vascular - Denver

Georgia

  • Georgia Heart Specialist - Covington
  • Northeast Georgia Heart Center, P.C. - Gainesville

Illinois

  • University of Chicago - Chicago
  • Advocate Medical Group - Chicago

Alaska

  • Alaska Heart Institute - Anchorage

California

  • Beaver Medical Group/Clinical Care Research - Banning

Trial Details

FieldValue
Enrollment Target 5,764 participants
Start Date 2007-07
Est. Completion 2026-11

Sponsor

Brigham and Women's Hospital

937 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01114269

The ClinicalTrials.gov registry entry for NCT01114269 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 5,764 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,261-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (357% higher). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 0 interventions.

NCT01114269 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Florida, Arizona, Colorado.

Frequently Asked Questions

What is clinical trial NCT01114269 about?

NCT01114269 is a clinical study titled "PRE-DETERMINE Cohort Study". This is a prospective, multi-center cohort study of patients with a history of coronary artery disease (CAD) and documentation of either a prior myocardial infarction (MI) or mild to moderate left ventricular dysfunction (LVEF 35-50%). The primary objective of this study is to determine whether biol...

What is the current status of trial NCT01114269?

This trial is currently active not recruiting. The enrollment target is 5,764 participants. The study started on 2007-07. Estimated completion is 2026-11.

What conditions does trial NCT01114269 study?

This clinical trial studies the following conditions: Coronary Artery Disease, Sudden Cardiac Death, Left Ventricular Dysfunction.

Who is sponsoring clinical trial NCT01114269?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01114269 being conducted?

This trial has 20 study locations across Alaska, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.