Acute Coronary SyndromeED~CardsNCT01984853
Cardiology-Emergency Medicine Cardiac Biomarker Research Initiative
An observational study of Acute Coronary Syndrome, run by Henry Ford Health System at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- OBSERVATIONAL REGISTRY
- How many people
- 575 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Apr 2015
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Patient greater than 21 years of age
- Experiencing symptoms of possible ACS
- Willing and able to comply with all aspect of the protocol
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Acute Coronary Syndrome
- Being tested
- OBSERVATIONAL REGISTRY
- Keywords
- ACS, repository, Observational
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OBSERVATIONAL REGISTRYOther
Also called This is an observational registry only, there are no Interventions.
| Study group | Role | What they receive |
|---|---|---|
| OBSERVATIONAL REGISTRY | Individuals presenting with signs and/or symptoms of Acute Coronary Syndrome at the Henry Ford Hospital Emergency Department (ED). Receives: Other: OBSERVATIONAL REGISTRY |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Secondary outcomes (1)
ACS Marker Evaluation
To evaluate early exclusion and/or inclusion of ACS with high sensitive cTn and newer cTn assays or other novel markers .
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startMay 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 575 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard M Nowak, Henry Ford Health System
- Investigators
- Dr. Richard M Nowak, MD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984853
- Sponsor's protocol ID
- HFHS: ED-CARDS ACS Registry
- Other IDs
- HFHS: ED CARDS Registry
- Acronym
- ED~Cards
- Status last verified
- Jul 2015
- First submitted
- 30 Oct 2013
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiology-Emergency Medicine Cardiac Biomarker Research Initiative
- ClinicalTrials.gov ID
- NCT01984853
- Acronym / sponsor ID
- ED~Cards / HFHS: ED-CARDS ACS Registry
- Conditions
- Acute Coronary Syndrome
- Keywords
- ACS, repository, Observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 575 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 15 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OBSERVATIONAL REGISTRY | – | Other: OBSERVATIONAL REGISTRYIndividuals presenting with signs and/or symptoms of Acute Coronary Syndrome at the Henry Ford Hospital Emergency Department (ED). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- Patient greater than 21 years of age
- Experiencing symptoms of possible ACS
- Willing and able to comply with all aspect of the protocol
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OBSERVATIONAL REGISTRYAlso: This is an observational registry only, there are no Interventions. | Other | OBSERVATIONAL REGISTRY |
Primary outcome
Study Objective
Time frame: 4 years
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.
1 secondary outcome
ACS Marker Evaluation
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Richard M Nowak, MD principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Objective (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2015.