Acute Myocardial InfarctionNCT01059214
Cardiac MRI for Patients Enrolled in INFUSE-AMI
An observational study of Acute Myocardial Infarction and Coronary Artery Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
Background: INFUSE AMI is an ongoing clinical trial examining how patients with heart attacks are treated. The study's aim is to help determine the best way to treat patients with specific kinds of heart attacks caused by blood clots. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction, Coronary Artery Disease, Myocardial Fibrosis
- How many people
- 455 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2009to 11 Oct 2012
- 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
Who may be able to join
None listed.
Who cannot join
- Known hypersensitivity or contraindication to gadolinium contrast
- Severe kidney disease (eGFR <30 mLIminIl .73 m(2) BSA)
- Pregnancy
- Breast feeding (unless subject is willing to discard breast milk for 24 hours)
- Cardiac pacemaker or implantable defibrillator
- Non-MRI compatible aneurysm clip
Show all 11Show fewer
- Neural stimulator (e.g. TENS unit)
- Any implanted or magnetically activated device (e.g. insulin pump)
- Any type of non-MRI compatible metallic ear implant
- Metal shavings in the orbits
- Any metallic or foreign body, shrapnel, or bullet in a location which the physician feels would present a risk to the subject
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Background:
- INFUSE AMI is an ongoing clinical trial examining how patients with heart attacks are treated. The study's aim is to help determine the best way to treat patients with specific kinds of heart attacks caused by blood clots.
- To evaluate the effect of the heart attack on the heart tissue and function, participants in the INFUSE-AMI study will have magnetic resonance imaging (MRI) scans of the heart at specific times after their heart attack.
Read more
Objectives:
- To perform cardiac MRI scans on patients who are participating in the INFUSE-AMI study.
Eligibility:
- Individuals at least 18 years of age who are enrolled in the INFUSE-AMI study.
Design:
- Participants will have an MRI scan of the heart about 5 days and between 23 and 44 days after their heart attack. The MRI scan at day 5 is optional.
- Participants will provide a blood sample prior to the MRI scan.
- During the scan, participants will be given a contrast drug to show the blood flow to and within the heart. An electrocardiogram will be used to monitor the heart during the procedure.
- No other treatment will be provided in this protocol.
Read the detailed description
The purpose of this research protocol is to perform contrast enhanced cardiac MRI studies on patients enrolled in the INFUSE-AMI study (INFUSE-AMI is a multicenter, open-label controlled single-blind randomized study with up to 452 patients enrolled in approximately 50 US and European sites). Patients who present with anterior ST elevation myocardial infarction by electrocardiogram (STEMI) and an occluded proximal or mid left anterior descending artery (LAD) with TIMI 0/1 flow will be eligible for randomization to one of the following arms: 1) Local infusion of Abciximab and thrombus aspiration, 2) Local infusion of Abciximab and no thrombus aspiration, 3) No local infusion and thrombus aspiration, or 4) No local infusion and no thrombus aspiration. Cardiac MRI is performed to assess left ventricular function and infarct size for the primary INFUSE-AMI study. Thus, this local research protocol will provide the cardiac MRI scans at no cost to the participant. Additional images of the heart will be obtained for local research purposes. Cardiac MRI scans will be performed at around 5 days (optional) and at 30 days after myocardial infarction.
- Conditions
- Acute Myocardial Infarction, Coronary Artery Disease, Myocardial Fibrosis, Gadolinium, Myocardial Edema
- Keywords
- Acute Myocardial Infarction, Reperfusion, MRI, Heart Attack
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2010 (estimated)
- Study start10 Dec 2009
- Study completion11 Oct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
- Time perspective
- Prospective
- Enrolment
- 455 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Andrew E Arai, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01059214
- Sponsor's protocol ID
- 100034
- Other IDs
- 10-H-0034
- Status last verified
- 11 Oct 2012
- First submitted
- 28 Jan 2010
- Last updated
- 13 Sep 2019
- Results posted
- No
Publications
Frank JA, Mattay VS, Duyn J, Sobering G, Barrios FA, Zigun J, Sexton R, Kwok P, Woo J, Moonen C, et al. Measurement of relative cerebral blood volume changes with visual stimulation by 'double-dose' gadopentetate-dimeglumine-enhanced dynamic magnetic resonance imaging. Invest Radiol. 1994 Jun;29 Suppl 2:S157-60. doi: 10.1097/00004424-199406001-00052. No abstract available.
PubMed 7928216Mattay VS, Weinberger DR, Barrios FA, Sobering GS, Kotrla KJ, van Gelderen P, Duyn JH, Sexton RH, Moonen CT, Frank JA. Brain mapping with functional MR imaging: comparison of gradient-echo--based exogenous and endogenous contrast techniques. Radiology. 1995 Mar;194(3):687-91. doi: 10.1148/radiology.194.3.7862963.
PubMed 7862963Deo A, Fogel M, Cowper SE. Nephrogenic systemic fibrosis: a population study examining the relationship of disease development to gadolinium exposure. Clin J Am Soc Nephrol. 2007 Mar;2(2):264-7. doi: 10.2215/CJN.03921106. Epub 2007 Feb 7.
PubMed 17699423
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac MRI for Patients Enrolled in INFUSE-AMI
- ClinicalTrials.gov ID
- NCT01059214
- Acronym / sponsor ID
- 100034
- Conditions
- Acute Myocardial Infarction, Coronary Artery Disease, Myocardial Fibrosis, Gadolinium, Myocardial Edema
- Keywords
- Acute Myocardial Infarction, Reperfusion, MRI, Heart Attack
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 10 Dec 2009
- Study completion
- 11 Oct 2012
- First posted
- 29 Jan 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.
Background:
- INFUSE AMI is an ongoing clinical trial examining how patients with heart attacks are treated. The study's aim is to help determine the best way to treat patients with specific kinds of heart attacks caused by blood clots.
- To evaluate the effect of the heart attack on the heart tissue and function, participants in the INFUSE-AMI study will have magnetic resonance imaging (MRI) scans of the heart at specific times after their heart attack.
Objectives:
- To perform cardiac MRI scans on patients who are participating in the INFUSE-AMI study.
Eligibility:
- Individuals at least 18 years of age who are enrolled in the INFUSE-AMI study.
Design:
- Participants will have an MRI scan of the heart about 5 days and between 23 and 44 days after their heart attack. The MRI scan at day 5 is optional.
- Participants will provide a blood sample prior to the MRI scan.
- During the scan, participants will be given a contrast drug to show the blood flow to and within the heart. An electrocardiogram will be used to monitor the heart during the procedure.
- No other treatment will be provided in this protocol.
Detailed description
The purpose of this research protocol is to perform contrast enhanced cardiac MRI studies on patients enrolled in the INFUSE-AMI study (INFUSE-AMI is a multicenter, open-label controlled single-blind randomized study with up to 452 patients enrolled in approximately 50 US and European sites). Patients who present with anterior ST elevation myocardial infarction by electrocardiogram (STEMI) and an occluded proximal or mid left anterior descending artery (LAD) with TIMI 0/1 flow will be eligible for randomization to one of the following arms: 1) Local infusion of Abciximab and thrombus aspiration, 2) Local infusion of Abciximab and no thrombus aspiration, 3) No local infusion and thrombus aspiration, or 4) No local infusion and no thrombus aspiration. Cardiac MRI is performed to assess left ventricular function and infarct size for the primary INFUSE-AMI study. Thus, this local research protocol will provide the cardiac MRI scans at no cost to the participant. Additional images of the heart will be obtained for local research purposes. Cardiac MRI scans will be performed at around 5 days (optional) and at 30 days after myocardial infarction.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- Known hypersensitivity or contraindication to gadolinium contrast
- Severe kidney disease (eGFR <30 mLIminIl .73 m(2) BSA)
- Pregnancy
- Breast feeding (unless subject is willing to discard breast milk for 24 hours)
- Cardiac pacemaker or implantable defibrillator
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 13 Sep 2019.
- Background: PubMed 7928216Frank JA, Mattay VS, Duyn J, Sobering G, Barrios FA, Zigun J, Sexton R, Kwok P, Woo J, Moonen C, et al. Measurement of relative cerebral blood volume changes with visual stimulation by 'double-dose' gadopentetate-dimeglumine-enhanced dynamic magnetic resonance imaging. Invest Radiol. 1994 Jun;29 Suppl 2:S157-60. doi: 10.1097/00004424-199406001-00052. No abstract available.
- Background: PubMed 7862963Mattay VS, Weinberger DR, Barrios FA, Sobering GS, Kotrla KJ, van Gelderen P, Duyn JH, Sexton RH, Moonen CT, Frank JA. Brain mapping with functional MR imaging: comparison of gradient-echo--based exogenous and endogenous contrast techniques. Radiology. 1995 Mar;194(3):687-91. doi: 10.1148/radiology.194.3.7862963.
- Background: PubMed 17699423Deo A, Fogel M, Cowper SE. Nephrogenic systemic fibrosis: a population study examining the relationship of disease development to gadolinium exposure. Clin J Am Soc Nephrol. 2007 Mar;2(2):264-7. doi: 10.2215/CJN.03921106. Epub 2007 Feb 7.
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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.
Andrew E Arai, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
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 Myocardial Infarction and Coronary Artery Disease, run by National Heart, Lung, and Blood Institute (NHLBI) 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 0 inclusion and 11 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 13 Sep 2019. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01059214, which also lists 3 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 13 Sep 2019.