NCT00415948

Brief Summary

The purpose of the study is to procure blood samples from patients who present to the Emergency Department with suspected ACS (Acute Coronary Syndrome).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2006

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 25, 2006

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

December 18, 2009

Status Verified

December 1, 2009

First QC Date

December 21, 2006

Last Update Submit

December 17, 2009

Conditions

Keywords

HeartCardiacAcute Coronary SyndromeSample Procurement

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting the to the ED within 6 hours with symptoms consistent with ACS.

You may qualify if:

  • Age 18 years or older at time of enrollment
  • Patient presenting to the ED within 6 hours or less from symptom (chest discomfort consistent with possible ACS) onset
  • Patient experiencing at least 30 minutes of chest discomfort, consistent with possible ACS, from time of symptom onset; patients who have symptoms of shorter duration due to pharmacologic intervention may be included
  • Physician plans to perform objective cardiac testing as defined by the protocol

You may not qualify if:

  • Patient (or legal representative) unable or unwilling to provide informed consent
  • Patient (or legal representative) refusal of medical record review or telephone follow-up at 30 days or 6 months
  • Patient (or legal representative) refusal of multiple blood sample collection over the study period
  • Prisoners or other institutionalized individuals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

UC Davis

Sacramento, California, United States

Location

Yale University

New Haven, Connecticut, United States

Location

St Agnes Hospital

Baltimore, Maryland, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, United States

Location

Henry Ford Health System

Detroit, Michigan, United States

Location

Spectrum Health Hospitals

Grand Rapids, Michigan, United States

Location

Ingham Regional Medical Center

Lansing, Michigan, United States

Location

New York Methodist Hosptial

Brooklyn, New York, United States

Location

SUNY Stony Brook

Stony Brook, New York, United States

Location

Duke University Medical Center

Durham, North Carolina, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Location

Ohio State University Medical Center

Columbus, Ohio, United States

Location

University of Virginia

Charlottesville, Virginia, United States

Location

Sentara Norfolk General Hopsital

Norfolk, Virginia, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma Specimens

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Frank Peacock, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2006

First Posted

December 25, 2006

Study Start

December 1, 2006

Study Completion

June 1, 2008

Last Updated

December 18, 2009

Record last verified: 2009-12

Locations