NCT01984853

Brief Summary

This is an OBSERVATIONAL Specimen procurement and data collections trial for acute coronary syndrome that will be conducted in the Emergency Department at Henry Ford Hospital. The standard protocol for evaluating patients in the Emergency Department for possible acute myocardial infarction includes the measurement of cardiac troponin over 3 hours. Subjects presenting to the ED with chest discomfort or ischemic symptoms will be eligible for blood draw protocol. The study is blinded to treating physicians and does not change current standard of care. After informed consent patients will have blood samples drawn at 0, 30 minutes, 1 hour and 3 hours. Serum from the samples will be stored in a -80 research freezer to be evaluated at a later time as new cardiac markers for acute coronary syndrome are developed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
575

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

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

May 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 15, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

Enrollment Period

1.9 years

First QC Date

October 30, 2013

Last Update Submit

July 30, 2015

Conditions

Acute Coronary Syndrome

Keywords

ACSrepositoryObservational

Outcome Measures

Primary Outcomes (1)

  • Study Objective

    The study objective is to collect blood and plasma specimens for the assessment of ACS Biologic Assessments in patients presenting to the Emergency Department with symptoms consistent with ACS according to Henry Ford Medical Group current system guidelines.

    4 years

Secondary Outcomes (1)

  • ACS Marker Evaluation

    5 years

Study Arms (1)

OBSERVATIONAL REGISTRY

Individuals presenting with signs and/or symptoms of Acute Coronary Syndrome at the Henry Ford Hospital Emergency Department (ED).

Other: OBSERVATIONAL REGISTRY

Interventions

OBSERVATIONAL REGISTRYOTHER
Also known as: This is an observational registry only, there are no Interventions.
OBSERVATIONAL REGISTRY

Eligibility Criteria

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

Candidates for enrollment will be individuals presenting with signs and/or symptoms of Acute Coronary Syndrome at the Henry Ford Hospital Emergency Department (ED).

You may qualify if:

  • Patient greater than 21 years of age
  • Experiencing symptoms of possible ACS
  • Willing and able to comply with all aspect of the protocol

You may not qualify if:

  • Acute distress and/or requires immediate life-saving intervention
  • CPR, external defibrillation or cardioversion within 24 hours of presentation
  • Unable to provide or understand the informed consent
  • STEMI leading to immediate reperfusion
  • Transferred from another facility
  • Trauma related injuries
  • Pregnancy or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Approximately 6-8.5 ml of blood will be collected in each of two anticoagulant tube types: SST and K2EDTA plasma. The first blood collection in the ED is designated as t0 ED ECG time (+ 60 minutes). Additional blood draws of approximately 6-8.5 mL/tube type will occur at t1 = 30 (+/- 10 minutes) after t0, t2=1 (+/-15 minutes) hour after t0, t4 = 3 (+/- 15 minutes) hours after t0 (if the patient is still in the ED/hospital).

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Dr. Richard M Nowak, MD

    Henry Ford Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
18 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 30, 2013

First Posted

November 15, 2013

Study Start

May 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

July 31, 2015

Record last verified: 2015-07

Locations

US(1)