Acute Coronary SyndromeMidas 3NCT01134913
Multi-Markers In the Diagnosis of Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome, run by Abbott RDx Cardiometabolic at 6 sites in United States.
Trial summary
This is a prospective clinical study designed to procure blood samples from patients who present to the Emergency Department with suspected ACS (Acute Coronary Syndrome). Subjects enrolled in this study will sign and informed consent and have 4 blood samples drawn at different time points during their emergency… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 621 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2010to Dec 2011
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to the ED within 6 hours with symptoms consistent with ACS.
Who may be able to join
- Patient is 18 years of age or older at time of enrollment.
- Patient presenting to the ED within 6 hours from the onset of symptoms consistent with ACS.
- Subject presented with at least one symptom outlined below:
- Chest discomfort of at least 5 minutes duration from time of symptom onset. Episodic or stuttering chest discomfort is acceptable if last episode preceding the ED presentation is within 6 hours of symptom onset.
- Chest discomfort of shorter duration due to pharmacologic intervention.
- Ischemic Equivalent, Chest Pain Syndrome, Anginal Equivalent, or Ischemic ECG Abnormalities.
- Physician plans to perform objective cardiac testing as defined by the protocol in Section 3.2.
Who cannot join
- Patient (or Legal Representative) unable or unwilling to provide informed consent.
- Patient (or Legal Representative) refusal of telephone follow-up or medical record review at 30 days, 90 days and 180 days post-ED presentation.
- Patient (or Legal Representative) refusal for multiple blood sample collections over the study period.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Hospital
Boston, Massachusetts, 02215
New York Methodist Hospital
Brooklyn, New York, 11215
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University of Pennsylvania
Philidelphia, Pennsylvania, 19104
SUNY Stony Brook
Stony Brook, New York, 11794
About this study
Official title: Multi-Markers In the Diagnosis of Acute Coronary Syndrome - Sample Procurement Cohort 3
This is a prospective clinical study designed to procure blood samples from patients who present to the Emergency Department with suspected ACS (Acute Coronary Syndrome).
Subjects enrolled in this study will sign and informed consent and have 4 blood samples drawn at different time points during their emergency department visit. In addition, data will be collected about the patient's health history, hospital procedures, and final diagnosis. The enrolling center will also contact the patients at 30-days, 3 months and 6 months to inquire about their condition and survival.
Blood samples collected in this study will be sent to the sponsor organization for long-term storage and analysis in the future for novel blood markers as they become available. No genetic testing will be conducted on these samples.
Read the detailed description
This is a prospective, multi-center, observational, and sample procurement study of adult subjects presenting to an Emergency Department (ED) in whom ACS is in the differential diagnosis. Subjects must present to one of the participating EDs within 6 hours or less from the time of symptom onset, and must have experienced at least 5 minutes of chest discomfort.
Those ED patients with possible ACS who meet the inclusion/exclusion criteria will be approached for study enrollment by trained research personnel.
The patient's diagnostic work-up and treatment will continue per the standards of the treating institution. As indicated by their clinical presentation, it is anticipated that all patients in this study will have an electrocardiogram (ECG) upon admission to the ED and if the patient is found not to have an ST-elevation myocardial infarction (STEMI), objective cardiac testing will be conducted for evidence of MI. The Principal Investigator at each site will evaluate the results of the objective cardiac tests combined with biomarker evidence of myocardial necrosis to determine whether or not a patient enrolled at their site has a final diagnosis of ACS.
Cardiac events and procedure, such as angioplasty-stenting and coronary artery bypass surgery (CABG), will be recorded during the index ED visit, hospitalization and post-hospital follow-up period. Subjects will have a 30-day, 3 month and 6 month follow-up contact by phone or medical chart review to collect this information on cardiac events, procedures and survival.
Blood samples collected at several time points during the index ED visit will be used for future testing of novel blood markers as they become available.
- Conditions
- Acute Coronary Syndrome
- Keywords
- ACS, Acute Coronary Syndrome, Emergency Department
- Medical subject headings
- Acute Coronary Syndrome, Emergencies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- 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
- 621 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott RDx Cardiometabolic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01134913
- Sponsor's protocol ID
- BSTE-0101-1
- Acronym
- Midas 3
- Status last verified
- Aug 2012
- First submitted
- 29 May 2010
- Last updated
- 31 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Smith SW, Diercks DB, Nagurney JT, Hollander JE, Miller CD, Schrock JW, Singer AJ, Apple FS, McCullough PA, Ruff CT, Sesma A Jr, Peacock WF. Central versus local adjudication of myocardial infarction in a cardiac biomarker trial. Am Heart J. 2013 Mar;165(3):273-279.e1. doi: 10.1016/j.ahj.2012.12.012. Epub 2013 Jan 26.
PubMed 23453092Peacock WF, Nagurney J, Birkhahn R, Singer A, Shapiro N, Hollander J, Glynn T, Nowak R, Safdar B, Miller C, Peberdy M, Counselman F, Chandra A, Kosowsky J, Neuenschwander J, Schrock J, Plantholt S, Lewandrowski E, Wong V, Kupfer K, Diercks D. Myeloperoxidase in the diagnosis of acute coronary syndromes: the importance of spectrum. Am Heart J. 2011 Nov;162(5):893-9. doi: 10.1016/j.ahj.2011.08.017.
PubMed 22093206
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Markers In the Diagnosis of Acute Coronary Syndrome - Sample Procurement Cohort 3
- ClinicalTrials.gov ID
- NCT01134913
- Acronym / sponsor ID
- Midas 3 / BSTE-0101-1
- Conditions
- Acute Coronary Syndrome
- Keywords
- ACS, Acute Coronary Syndrome, Emergency Department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 621 participants (actual)
- Lead sponsor
- Abbott RDx CardiometabolicUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 2 Jun 2010 (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 a prospective clinical study designed to procure blood samples from patients who present to the Emergency Department with suspected ACS (Acute Coronary Syndrome).
Subjects enrolled in this study will sign and informed consent and have 4 blood samples drawn at different time points during their emergency department visit. In addition, data will be collected about the patient's health history, hospital procedures, and final diagnosis. The enrolling center will also contact the patients at 30-days, 3 months and 6 months to inquire about their condition and survival.
Blood samples collected in this study will be sent to the sponsor organization for long-term storage and analysis in the future for novel blood markers as they become available. No genetic testing will be conducted on these samples.
Detailed description
This is a prospective, multi-center, observational, and sample procurement study of adult subjects presenting to an Emergency Department (ED) in whom ACS is in the differential diagnosis. Subjects must present to one of the participating EDs within 6 hours or less from the time of symptom onset, and must have experienced at least 5 minutes of chest discomfort.
Those ED patients with possible ACS who meet the inclusion/exclusion criteria will be approached for study enrollment by trained research personnel.
The patient's diagnostic work-up and treatment will continue per the standards of the treating institution. As indicated by their clinical presentation, it is anticipated that all patients in this study will have an electrocardiogram (ECG) upon admission to the ED and if the patient is found not to have an ST-elevation myocardial infarction (STEMI), objective cardiac testing will be conducted for evidence of MI. The Principal Investigator at each site will evaluate the results of the objective cardiac tests combined with biomarker evidence of myocardial necrosis to determine whether or not a patient enrolled at their site has a final diagnosis of ACS.
Cardiac events and procedure, such as angioplasty-stenting and coronary artery bypass surgery (CABG), will be recorded during the index ED visit, hospitalization and post-hospital follow-up period. Subjects will have a 30-day, 3 month and 6 month follow-up contact by phone or medical chart review to collect this information on cardiac events, procedures and survival.
Blood samples collected at several time points during the index ED visit will be used for future testing of novel blood markers as they become available.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the ED within 6 hours with symptoms consistent with ACS.
Key inclusion criteria (7 listed)
- Patient is 18 years of age or older at time of enrollment.
- Patient presenting to the ED within 6 hours from the onset of symptoms consistent with ACS.
- Subject presented with at least one symptom outlined below:
- Physician plans to perform objective cardiac testing as defined by the protocol in Section 3.2.
Key exclusion criteria (3 listed)
- Patient (or Legal Representative) unable or unwilling to provide informed consent.
- Patient (or Legal Representative) refusal of telephone follow-up or medical record review at 30 days, 90 days and 180 days post-ED presentation.
- Patient (or Legal Representative) refusal for multiple blood sample collections over the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 Aug 2012.
- Derived from this study: PubMed 23453092Smith SW, Diercks DB, Nagurney JT, Hollander JE, Miller CD, Schrock JW, Singer AJ, Apple FS, McCullough PA, Ruff CT, Sesma A Jr, Peacock WF. Central versus local adjudication of myocardial infarction in a cardiac biomarker trial. Am Heart J. 2013 Mar;165(3):273-279.e1. doi: 10.1016/j.ahj.2012.12.012. Epub 2013 Jan 26.
- Derived from this study: PubMed 22093206Peacock WF, Nagurney J, Birkhahn R, Singer A, Shapiro N, Hollander J, Glynn T, Nowak R, Safdar B, Miller C, Peberdy M, Counselman F, Chandra A, Kosowsky J, Neuenschwander J, Schrock J, Plantholt S, Lewandrowski E, Wong V, Kupfer K, Diercks D. Myeloperoxidase in the diagnosis of acute coronary syndromes: the importance of spectrum. Am Heart J. 2011 Nov;162(5):893-9. doi: 10.1016/j.ahj.2011.08.017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites 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 Abbott RDx Cardiometabolic at 6 sites 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 7 inclusion and 3 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 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01134913, which also lists 2 linked publications.
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 Aug 2012.