Cardiology-Emergency Medicine Cardiac Biomarker Research Initiative (ED~Cards)

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Other: OBSERVATIONAL REGISTRY

Detailed Description

Subjects considered for enrollment in this study will be identified and approached by either the Principal Investigator or trained study coordinator (SC). Candidates for enrollment will be individuals presenting with signs and/or symptoms of Acute Coronary Syndrome at the Henry Ford Hospital Emergency Department (ED).

This specimen collection study is a prospective serial draw plasma collection study designed to collect specimens for use in existing or future clinical studies. Specimen collection is expected to take approximately 30-36 months. Specimens will be collected from subjects that are being evaluated for Acute Coronary Syndrome (ACS).

Other than sample collection, no special procedures or medications are required by the study.

The study aims to enroll approximately 250-500 individuals evaluated for possible ACS in the ED.

Specimens will be obtained from the subject at the following time points:

t0 =Baseline ECG (ECG time + 60 minutes) t1= within 30 (+/- 10 minutes) minutes after t0 t2 = 1 (+/- 15 minutes) hours after t0 t3 = 3 (+/-15 minutes) hours after t0

Each sample will consist of approximately 6-8.5 ml of blood in each of two anticoagulant tube types: SST and K2EDTA plasma. Four serial specimens will be collected within 3 hours of presentation to the ED for observation of ACS.

• The Investigator or designee will obtain the subject's written informed consent prior to collecting the specimen.
• Each subject will be given a unique study number. An enrollment log will be used to document the enrollment of individuals by study number. This study number will be used to identify the individual throughout the study.
• Each subject will have a medical history reviewed and documented, as well as significant cardiac medical history documented in the subject's case report form in addition to demographic information including age, gender, race, ethnicity, and medication history.
• Each subject will have a baseline ECG obtained in the ED, vital signs and routine laboratory results. These will be documented in the subject's case report form.
• 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).
• For each draw, a minimum volume (after processing) of approximately 2 mL of plasma should be obtained. The specimens will be processed, aliquoted, and retained in a -70 secured freezer.

Inclusion/Exclusion Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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

• Study Type: Observational
• Enrollment (Actual): 575

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability 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).

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
OBSERVATIONAL REGISTRY; Individuals presenting with signs and/or symptoms of Acute Coronary Syndrome at the Henry Ford Hospital Emergency Department (ED).	Other: OBSERVATIONAL REGISTRY; Other Names: This is an observational registry only, there are no Interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACS Marker Evaluation	To evaluate early exclusion and/or inclusion of ACS with high sensitive cTn and newer cTn assays or other novel markers .	5 years

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Investigators: Principal Investigator: Dr. Richard M Nowak, MD, Henry Ford Health System

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: October 30, 2013
• First Submitted That Met QC Criteria: November 7, 2013
• First Posted (Estimate): November 15, 2013

Study Record Updates

• Last Update Posted (Estimate): July 31, 2015
• Last Update Submitted That Met QC Criteria: July 30, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Observational; ACS; repository
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Emergencies; Acute Coronary Syndrome
• Other Study ID Numbers: HFHS: ED-CARDS ACS Registry; HFHS: ED CARDS Registry (Registry Identifier: HFHS: ED~Cards Collaborative)