Heart Disease, IschemicIMAgineNCT00355992
The Ischemia Modified Albumin In Diagnosing Ischemic New Events
An observational study of Heart Disease, Ischemic and Ischemia, Myocardial, run by Inverness Medical Innovations at 5 sites in 2 countries.
Trial summary
The purpose of the study is to evaluate the utility of Ischemia Modified Albumin (IMA) for risk stratification in patients presenting with chest discomfort and possible ischemic heart disease, and to evaluate the diagnostic and prognostic implication for IMA for major adverse cardiac events. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Disease, Ischemic, Ischemia, Myocardial, Ischemic Heart Disease
- How many people
- 1,250 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Sep 2006to Dec 2007
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who present in the emergency department at the listed institutions with suspected ischemic signs and or symptoms (chest pain) will be eligible for participation in the study as long as they meet inclusion and exclusion criteria and sign an informed consent.
Who may be able to join
- Patients with primary complaints of chest discomfort or patients with symptoms indicative of a moderate to high probability for unstable angina clinically indicated reason for evaluation for ACS in the Emergency Department meeting tyhe following inclusion criteria will be enrolled:
- Age >=21 years
- Presentation within two hours of relief of most recent episode of chest pain or presence of on-going symptoms suggestive of coronary ischemia, which should be at least 10 minutes in duration.
- Patients being evaluated for suspected ischemic signs and or symptoms (chest pain) at the time of presentation according to routine standard of care institutional chest pain protocol/pathway.
Who cannot join
- Administration of thrombolytic medication prior to first (presentation) blood draw
- Acute coronary syndrome (ACS) secondary to supply/demand inequity (i.e. known anemia, tachycardia, - defined as HR greater than 150 bpm, known sepsis, hypotension, defined as blood pressure < 90 mmHg).
- Established diagnosis of liver cirrhosis
- Other acute ischemic sources (ongoing severe claudication, mesenteric ischemia, acute TIA/CVA)
- Renal failure requiring dialysis
- Greater than 2 hours from relief of the most recent episode of chest pain or signs and symptoms suggestive of coronary ischemia.
Show all 15Show fewer
- Chest pain following traumatic injury to the chest
- Evidence for sever systemic infection, manifesting as fever (temperature >100 degrees) and systolic blood pressure <100 mmHg
- Patients unwilling or unable to provide written consent, without available next of kin
- Cocaine-related chest pain
- Pregnancy
- Known diagnosis of active malignancy
- Acute Bowel Ischemia
- Severe peripheral vascular disease
- Acute brain ischemia
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Massachusetts General Hospital
Boston, Massachusetts
Cleveland Clinic
Cleveland, Ohio, 44195
Dartmouth Medical Center
Lebanon, New Hampshire
Vanderbilt University
Nashville, Tennessee
About this study
Official title: The Ischemia Modified Albumin In Diagnosing Ischemic New Events (IMAGINE Study).
The purpose of the study is to evaluate the utility of Ischemia Modified Albumin (IMA) for risk stratification in patients presenting with chest discomfort and possible ischemic heart disease, and to evaluate the diagnostic and prognostic implication for IMA for major adverse cardiac events.
- Keywords
- Myocardial Ischemia, Chest pain, Ischemia Modified Albumin, Acute Coronary Syndrome
- Medical subject headings
- Myocardial Ischemia, Angina, Unstable, Chest Pain, Acute Coronary Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2006 (estimated)
- Study startSep 2006
- Study completionDec 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Disease, IschemicStudies 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
- 1,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inverness Medical Innovations
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James L Januzzi, M.D., Study director, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355992
- Sponsor's protocol ID
- IMA-0106-001.04
- Acronym
- IMAgine
- Status last verified
- May 2009
- First submitted
- 27 Jun 2006
- Last updated
- 12 May 2009
- Results posted
- No
Publications
Bhardwaj A, Truong QA, Peacock WF, Yeo KT, Storrow A, Thomas S, Curtis KM, Foote RS, Lee HK, Miller KF, Januzzi JL Jr. A multicenter comparison of established and emerging cardiac biomarkers for the diagnostic evaluation of chest pain in the emergency department. Am Heart J. 2011 Aug;162(2):276-282.e1. doi: 10.1016/j.ahj.2011.05.022.
PubMed 21835288
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ischemia Modified Albumin In Diagnosing Ischemic New Events (IMAGINE Study).
- ClinicalTrials.gov ID
- NCT00355992
- Acronym / sponsor ID
- IMAgine / IMA-0106-001.04
- Keywords
- Myocardial Ischemia, Chest pain, Ischemia Modified Albumin, Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 1,250 participants (estimated)
- Lead sponsor
- Inverness Medical InnovationsIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Study completion
- Dec 2007 (estimated)
- First posted
- 25 Jul 2006 (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.
The purpose of the study is to evaluate the utility of Ischemia Modified Albumin (IMA) for risk stratification in patients presenting with chest discomfort and possible ischemic heart disease, and to evaluate the diagnostic and prognostic implication for IMA for major adverse cardiac events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who present in the emergency department at the listed institutions with suspected ischemic signs and or symptoms (chest pain) will be eligible for participation in the study as long as they meet inclusion and exclusion criteria and sign an informed consent.
Key inclusion criteria (4 listed)
- Patients with primary complaints of chest discomfort or patients with symptoms indicative of a moderate to high probability for unstable angina clinically indicated reason for evaluation for ACS in the Emergency Department meeting tyhe following inclusion criteria will be enrolled:
- Age >=21 years
- Presentation within two hours of relief of most recent episode of chest pain or presence of on-going symptoms suggestive of coronary ischemia, which should be at least 10 minutes in duration.
- Patients being evaluated for suspected ischemic signs and or symptoms (chest pain) at the time of presentation according to routine standard of care institutional chest pain protocol/pathway.
Key exclusion criteria (15 listed)
- Administration of thrombolytic medication prior to first (presentation) blood draw
- Acute coronary syndrome (ACS) secondary to supply/demand inequity (i.e. known anemia, tachycardia, - defined as HR greater than 150 bpm, known sepsis, hypotension, defined as blood pressure < 90 mmHg).
- Established diagnosis of liver cirrhosis
- Other acute ischemic sources (ongoing severe claudication, mesenteric ischemia, acute TIA/CVA)
- Renal failure requiring dialysis
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 was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2009.
- Derived from this study: PubMed 21835288Bhardwaj A, Truong QA, Peacock WF, Yeo KT, Storrow A, Thomas S, Curtis KM, Foote RS, Lee HK, Miller KF, Januzzi JL Jr. A multicenter comparison of established and emerging cardiac biomarkers for the diagnostic evaluation of chest pain in the emergency department. Am Heart J. 2011 Aug;162(2):276-282.e1. doi: 10.1016/j.ahj.2011.05.022.
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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.
James L Januzzi, M.D. study director
Massachusetts General Hospital
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Disease, Ischemic and Ischemia, Myocardial, run by Inverness Medical Innovations at 5 sites in 2 countries.
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 4 inclusion and 15 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: stopped early, as of the sponsor's last update on 12 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. 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 was stopped early. Results are not available in the source record.
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 NCT00355992, which also lists 1 linked publication.
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 12 May 2009.