Clinical trial NCT01984853: Cardiology-Emergency Medicine Cardiac Biomarker Research Initiative
Official title: Cardiology-Emergency Medicine Cardiac Biomarker Research Initiative
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: ACS
repository
Observational
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2013-11-15
Enrollment: 575
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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

Eligibility 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

Primary outcomes:
measure: Study Objective
timeFrame: 4 years
Secondary outcomes:
measure: ACS Marker Evaluation
timeFrame: 5 years
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: Dr. Richard M Nowak, MD
role: PRINCIPAL_INVESTIGATOR
References: